Showing posts with label Posttraumatic Stress Disorder (PTSD). Show all posts
Showing posts with label Posttraumatic Stress Disorder (PTSD). Show all posts

Monday, July 20, 2026

Randomized Controlled Trial on the ASSYST Treatment Intervention with Female Children Polytraumatized by Adverse Childhood Experiences, Neglect, and Maltreatment- Juniper Publishers

 

Pediatrics & Neonatology- Juniper Publishers


Abstract

The aim of this randomized controlled trial with an intention-to-treat analysis was to evaluate the effectiveness, efficacy, and safety of the Acute Stress Syndrome Stabilization Individual (ASSYST-I) treatment intervention in reducing posttraumatic stress disorder (PTSD) symptoms in female children polytraumatized by adverse childhood experiences, neglect, and maltreatment. A total of 40 female children met the inclusion criteria and participated in the study. Participants’ ages ranged from 8 to 17 years old (M =14.67 years). A two-arm randomized controlled trial (RCT) design was applied. PTSD symptoms were measured in three-time points for all participants in the study. Results showed that the intervention had a significant effect for time on PTSD symptoms (F (2,76) = 36.92 p <.000, η² = .493). A significant effect for group was also found (F (1, 38 = 32.7, p<.005, η² = .896) with a large effect, and a significant interaction between time and group, (F (2, 76) = 56.00, p <.000, η² = .600). Means comparison using t test between groups showed significant differences between the Treatment Group (TG) and the Control Group (CG) in the three-time points comparisons showing a large effect on Time 2 (Post-treatment assessment) which was maintained on Time 3 (Follow-up assessment). Results on the Reliable Change Index (RCI) and the Clinically Significant Change (CSC) Margin showed that the ASSYST-I treatment intervention exhibited reliable change on PTSD symptom reduction and clinically significant change, indicating that the treatment group participants are more likely to belong to the non-PTSD population after the intervention. Conversely, the control group participants are more likely to belong to the PTSD population. No adverse effects or events were reported by the participants during the treatment procedure administration or at follow-up. None of the participants showed clinically significant worsening/exacerbation of symptoms after treatment. Participants in the control group received the intervention treatment after the follow-up assessment, fulfilling our ethical criteria.

Keywords: Acute Stress Syndrome Stabilization; ASSYST; Posttraumatic stress disorder (PTSD), Female Children; Adverse Childhood Experiences; Neglect and Maltreatment

Introduction

Childhood abuse, neglect, and maltreatment, and especially polytraumatization, are known contributing factors to long-term insidious detrimental health defects. While definitions of abuse, neglect, and maltreatment vary and have evolved, the consensus in the scientific literature is that child maltreatment refers to acts of both commission (abuse) and omission or deprivation (neglect) that result in harm, potential harm, or threat of harm to a child and encompasses a variety of lived experiences [1]. These health defects in adults, such as diabetes, heart attack, obesity, cardiovascular and respiratory diseases, cancer, higher mortality rate, drug abuse, depression, anxiety, have been correlated with those who have lived adverse childhood experiences or ACEs, which include child abuse, neglect, and maltreatment, and are partially due to homeostatic changes to physiology and epigenetic processes during critical developmental periods [2-9].

Specifically, ages 3–5 have been associated with hippocampus development and exposure to abuse, neglect, and maltreatment may result in heightened vulnerability to later dissociation and posttraumatic stress disorder (PTSD), with ages 11–13 a key period affecting hippocampal development if exposed to abuse and neglect, age 10-11 affecting amygdala development, and ages 14-16 affecting prefrontal cortex development [10]. The neural processes affected in those who have experienced child abuse, neglect, and maltreatment are mainly in fronto-limbic networks including the medial prefrontal cortex, orbitofrontal cortex, anterior cingulate cortex, hippocampus, and amygdala, with neglect related to developmental changes in insula activation during risk processing and abuse related to developmental changes in fronto-parietal activation during cognitive control [11]. Studies also show that a smaller volume and altered activity patterns in the ventromedial region of the prefrontal cortex (vmPFC) have been observed in children with PTSD, suggesting the implication of frontal lobe circuitry in altered fear extinction features, affecting fear conditioning and learning, having important treatment implications [12].

The prevalence of child abuse, neglect, and maltreatment is alarming. On April 6, 2022, the United States Center for Disease Control and Prevention (CDC) reported that 1,750 children died of abuse and neglect in the year 2020 and that of the 74.2 million children in the US 10.6 million, or 1 out of 7, has experienced maltreatment in the previous year, which is likely underestimated due to lack of reporting [13]. Therefore, the need for prevention of child abuse, neglect, and maltreatment is crucial. In instances where prevention is not occurring, effective, efficient, and safe evidence-based PTSD treatment interventions for polytraumatized children is essential for the health, growth, and functioning of individuals, families, and communities.

AIP Theoretical Model

According to the Adaptive Information Processing (AIP) theoretical model memory networks of stored experiences are the basis of both human mental health and human pathology across the clinical spectrum. AIP disruptions due to high arousal states from adverse life experiences result in pathogenic memories that are inadequately processed and dysfunctionally stored in the brain. The information stored in these neurophysiological memory networks generates the present suffering, difficulties, and symptoms across the clinical spectrum [14,15].

PTSD and Intrusion Symptoms

According to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition; DSM-5) posttraumatic stress disorder (PTSD) is a trauma- and stressor-related disorder occurring after exposure to one or more traumatic events (Criterion A). These Criterion A events include, but are not limited to, threatened or actual physical assault (e.g., childhood physical abuse, physical attack), threatened or actual sexual violence (e.g., forced sexual penetration, alcohol/drug-facilitated sexual penetration, abusive sexual contact, noncontact sexual abuse, sexual trafficking) (p. 274) [16].

PTSD Intrusion Symptoms associated with the traumatic event(s), beginning after the traumatic event occurred, are 1. Recurrent, involuntary, and intrusive distressing memories of the traumatic event(s). 2. Recurrent distressing dreams in which the content and/or affect of the dream are related to the traumatic event(s). 3. Dissociative reactions (e.g., flashbacks) in which the individual feels or acts as if the traumatic event(s) were recurring. 4. Intense or prolonged psychological distress at exposure to internal or external cues that symbolize or resemble an aspect of the traumatic event(s). 5. Marked physiological reactions to internal or external clues that symbolize or resemble an aspect of the traumatic event(s). “These intrusive memories often include sensory (e.g., sensing the intense heat that was perceived in a house fire), emotional (e.g., experiencing the fear of believing that one was about to be stabbed), or physiological (e.g., experiencing the shortness of breath that one suffered during a near-drowning) components.Some individuals with the disorder do not have intrusive memories of the event itself, but instead experience intense psychological distress or physiological reactivity when they are exposed to triggering events that resemble or symbolize an aspect of the traumatic event” (p. 271, 282-283) [16].

Acute Stress Syndrome Stabilization Individual Treatment Intervention

The Acute Stress Syndrome Stabilization (ASSYST) Individual treatment intervention was born during humanitarian fieldwork and is an AIP-informed, evidence-based, carefully field-tested, and user-friendly psychophysiological algorithmic approach, whose reference is the EMDR Protocol for Recent Critical Incidents and Ongoing Traumatic Stress (EMDR-PRECI) [17-25]. This treatment intervention is specifically designed to provide in-person or online support to clients who present Acute Stress Disorder (ASD) or Posttraumatic Stress Disorder (PTSD) intense psychological distress and/or physiological reactivity caused by the disorders’ intrusion symptoms associated with the memories of the adverse experience(s).

The objective of this treatment intervention is focused on the patient’s Autonomic Nervous System sympathetic branch hyperactivation regulation through the reduction or removal of the activation produced by the sensory, emotional, or physiological components of the pathogenic memories of the adverse experience(s) to achieve optimal levels of Autonomic Nervous System activation, stop the three major stress hormones [adrenaline (epinephrine), noradrenaline (norepinephrine), and cortisol] secretion, and reestablish the Prefrontal Cortex functions (e.g., processing of information); thus, facilitating the AIP-system and the subsequent adaptive processing of information [26].

Previous ASSYST Treatment Intervention Studies:

Seven previous studies on the ASSYST treatment interventions have proven their efficacy and safety with different populations: (I) General population in lockdown and with ongoing traumatic stress during the COVID-19 Pandemic. (II) TeleMental Health counseling to the general population after adverse experiences. (III) Mental Health Professionals working during the COVID-19 Pandemic with patients suffering from trauma-related disorders and stressors. (IV) General population with non-recent pathogenic memories. (V) Adult Syrian refugees living in Lebanon. (VI) Adult Females with Adverse Childhood Experiences. (VII) Public sector workers during the COVID-19 pandemic [27-33].

Reliable Change Index and Clinically Significant Change Margin

To know whether PTSD symptoms change does indeed indicate reliable and clinical significant change in this study, we used the Reliable Change Index (RCI) and the Clinically Significant Change (CSC) Margin. The RCI is used to determine if the magnitude of observed change over time on a given measure is beyond what should be attributed to measurement error. The CSC is used to determine if an observed end score on a measure of symptomatology indicates that respondent is more likely to belong to the non-disordered population than the disordered population. For the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL- 5), the more conservative value of the RCI is 18-points and ≤ 28 end score for the CSC margin [34].

Objective

The objective of this randomized controlled trial with intention-to-treat analysis was to evaluate the effectiveness, efficacy, and safety of the Acute Stress Syndrome Stabilization Individual (ASSYST-I) treatment intervention in reducing posttraumatic stress disorder (PTSD) symptoms in female children polytraumatized by adverse childhood experiences, neglect, and maltreatment.

Method

Study design

To measure the effectiveness of the ASSYST-I on the dependent variable PTSD symptoms, this study with an intention-to-treat analysis used a two-arm randomized controlled trial (RCT) with a waitlist no-treatment control group design. PTSD symptoms were measured at three time points for all participants in the study: Time 1. Pre-treatment assessment; Time 2. Post-treatment assessment; and Time 3. Follow-up assessment. For ethical reasons, all participants in the control group received the intervention treatment after the follow-up assessment was competed.

Ethics and research quality

The research protocol was reviewed and approved by the EMDR Mexico International Research Ethics Review Board (also known in the United States of America as an Institutional Review Board) in compliance with the International Committee of Medical Journal Editors recommendations, the Guidelines for Good Clinical Practice of the European Medicines Agency (version 1 December 2016), and the Helsinki Declaration as revised in 2013. The research quality of this study was based on the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement and the Standard Protocol Items Recommendation for Interventional Trials (SPIRIT) 2013 checklist [35,36].

Participants

This study was conducted in Toluca City, Mexico, from May to July 2023, with the Mexican (Latina) female child population with pathogenic memories from adverse childhood experiences (ACEs), neglect, and maltreatment living in a center under the Mexican Government’s protection. Forty-seven potential participants were recruited. Inclusion criteria was: (a) being a female child, (b) having pathogenic memories from ACEs, neglect, and maltreatment causing current distress, (c) voluntarily participating in the study, (d) not receiving specialized trauma therapy, (e) not receiving drug therapy for PTSD symptoms, (f) having a PCL-5 total score of 33 points or more. Exclusion criteria was: (a) ongoing self-harm/suicidal or homicidal ideation, (b) diagnosis of schizophrenia, psychotic, or bipolar disorder, (c) diagnosis of a dissociative disorder, (d) organic mental disorder, (e) a current, active chemical dependency problem, (f) significant cognitive impairment (e.g., severe intellectual disability, dementia), (g) presence of uncontrolled symptoms due to a medical illness. Seven of the 47 potential participants were excluded due to having PCL-5 scores under 33 points (subclinical symptoms). These seven participants have been living in the center since they were very young and were not exposed to prolonged adverse experiences like the other participants. A total of 40 females children met the inclusion criteria and participated in the study. Participants’ ages ranged from 8 to 17 years old (M =14.67 years). Participation was voluntary with the participants’ and their legal guardians signed informed consent in accordance with the Mental Capacity Act 2005.

Instruments for Psychometric Evaluation

a) We used the Trauma Screen Checklist from the Child PTSD Symptom Scale for DSM-5 for trauma-exposed children and adolescents for the study participants to choose the traumatic events they have lived prior to being rescued by the Mexican Government. This list contains 15 frightening or stressful events that can happen to children and all of them fulfill DSM-5 PTSD Criterion A. Participants chose the event that bothered them the most to answer the PCL-5 during the three assessment times [37,38].

b) To measure PTSD symptom severity and treatment response, we used the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) provided by the National Center for PTSD (NCPTSD) with the time interval for symptoms to be the past week. The instrument was translated and back-translated to Spanish. It contains 20 items, including three new PTSD symptoms (compared with the PTSD Checklist for DSM-IV) [39,40]: blame, negative emotions, and reckless or self-destructive behavior. Respondents indicated how much they have been bothered by each PTSD symptom over the past week (rather than the past month), using a 5-point Likert scale ranging from 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. A total symptom score of zero to 80 can be obtained by summing the items. The sum of the scores yields a continuous measure of PTSD symptom severity for symptom clusters and the whole disorder. Psychometrics for the PCL-5, validated against the Clinician- Administered PTSD Scale-5 (CAPS-5) diagnosis, suggest that a score of 31-33 is optimal to determine probable PTSD diagnosis, and a score of 33 is recommended for use at present [38-40].

Procedure

Randomization, Allocation Concealment Mechanism, and Blinding Procedure

A computer-generated simple randomization with a 1:1 allocation ratio was used. Two independent assessors blind to treatment conditions conducted the randomization process to avoid allocation influence. The treatment random allocation sequence was concealed using sequentially numbered, opaque, sealed, and stapled envelopes who were open only after they were irreversibly assigned to the participants. The safekeeping of the envelopes and the assignment of participants to each arm of the trial (implementation of the random allocation sequence) was overseen by a person not involved in the research study and independent of the enrollment personnel. The treatment allocation of the participants was blinded for the research assistants who conducted the intake interview, initial assessment, and enrollment, and also for the independent assessors who conducted the followup assessments. Participants were instructed to not reveal their treatment allocation to the persons conducting the assessments. Twenty participants were allocated in the treatment group (TG) and twenty participants in the control group (CG). See Figure 1. Flow Diagram.

Enrollment, Assessments Times, Blind Data Collection, and Confidentiality of Data

Treatment group (TG) and control group (CG) participants completed the instruments in person and on an individual basis during distinct assessment moments. During Time 1, research assistants formally trained in all of the instruments’ administration, who were not blind to the study, but blind to the participant’s treatment allocation, conducted the intake interview, collected demographic data (e.g., name, age, gender, and contact information), assessed potential participants for eligibility based on the inclusion/exclusion criteria, obtained signed informed consent from the participants and their legal guardians, conducted the pre-treatment application of instruments, enrolled participants in the study, and randomly assigned each treatment group participant to one of the four clinicians formally trained in the ASSYST-I that participated in this study.

The research assistants also assisted the participants in identifying the pathogenic memory of their worst adverse experience from the Trauma Screen Checklist to be treated with the ASSYST-I. Each identified memory was written down by the research assistants on the Memory Record Sheets that were utilized by the clinicians during the ASSYST-I treatment intervention and utilized by participants during the three assessments times to ensure participants were focusing on the same memory when they received the treatment intervention, as well as the specific assessment time when they completed the assessment tools.

To obtain maximally interpretable PCL-5 scores, research assistants and independent assessors a) discussed with each participant the purpose of the instrument in detail, b) encouraged attentive and specific responding, c) invited participants to read each question carefully before responding and to select the correct answer, d) clarified their questions about some the symptoms, such as differentiating between intrusive memories and flashbacks, e) reworded conceptually complex symptoms (i.e., symptoms in the reexperiencing cluster) when necessary, f) reminded participants of the last-week symptom’s time frame, as well as, g) to only report symptoms related to the pathogenic memory of their worst adverse experience and not based on their everyday general distress.

During Time 2 (post-treatment assessment 7 days after treatment), and Time 3 (follow-up assessment 30 days after treatment), assessments were conducted for all participants by blind to treatment allocation independent assessors with formal training in administration of the instruments. The data safe keeper independent assessor received the participant’s assessment instruments that were answered during Times 1, 2, and 3. All data was collected, stored, and handled in full compliance with the EMDR Mexico International Research Ethics Review Board requirements to ensure confidentiality. Each study participant and their legal guardians gave their consent for access to their data, which was strictly required for study quality control. All procedures for handling, storing, destroying, and processing data were in compliance with the Data Protection Act 2018. All persons involved in this research project were subject to a signed professional confidentiality agreement.

Withdrawal from the Study and Missing Data

All research participants had the right to withdraw from the study without justification at any time and with assurances of no prejudicial result. If participants decided to withdraw from the study, they were no longer followed up in the research protocol. There were no withdrawals or missing data during this study.

Treatment

Clinicians and Treatment Fidelity

The ASSYST-I was provided in-person to individual participants by four licensed clinicians formally trained in this treatment intervention. Clinicians received on-going supervision and clinical feedback from the research project Clinical Director through daily group supervision and completing detailed session summary forms for each session with each participant that they were assigned that were designed specifically for the ASSYST-I treatment intervention to guide, elicit, monitor, and facilitate clinicians’ treatment adherence.

Treatment Description and Treatment Safety

An AIP & Symptom trajectory-based stepped care approach to adverse experiences was used during this study. This means a stepped progression of mental health care provided in an increasingly intensified manner based on the ongoing monitoring of the PTSD symptom trajectory during the study. The main objectives of this approach are a) to strategize treatment, b) to provide the treatment interventions according to the progression of the pathophysiology, and c) to improve symptom relief and clinical outcomes. After an adverse experience, the steps we follow are based on current evidence-based interventions. Step 1. Watchful waiting (monitoring of symptoms over time). Step 2. Psychoeducation, and support from families and close friends. Step 3. ASSYST for Individuals or Groups. Step 4. EMDR Integrative Group Treatment Protocol. Step 4. EMDR Protocol for Recent Critical Incidents and Ongoing Traumatic Stress. Step 5. Pharmacotherapy.

Participants’ treated memories were an average of 4.56 years old and received six in-person sessions, with an average length of 35-40 minutes per session. The ASSYST-I treatment intervention focused on the pathogenic memory produced by the worst adverse experience selected during T1. Pre-treatment assessment. To ensure the continuity and congruency of the intervention and measurement of its efficiency and efficacy, as mentioned above, during the intake interview after the memory was selected, the research assistants conducting the intake interview wrote down the specific memory on a Memory Record Sheet, which was used during each session of the ASSYST-I treatment procedure and was referenced to answer T1, T2, and T3 assessments.

At the beginning of the first treatment session, the participants were asked to run a mental movie of the specific previously selected memory, and then to choose the worst part. The treatment intervention was considered complete when the participant’s subjective levels of disturbance associated with the pathogenic memory decreased to zero or one (ecological/realistic). The ASSYST treatment intervention was provided to all the treatment group participants in an intensive treatment modality with two 60 minutes (max) sessions provided per day over three consecutive days.

Treatment safety was defined as the absence of adverse effects, events, or symptoms worsening. Therefore, participants were instructed by their clinicians to immediately report any adverse effects (e.g., dissociative symptoms [derealization/ depersonalization], fear, panic, freeze, shut down, collapse, fainting); events (e.g., suicidal ideation, suicide attempts, selfharm, homicidal ideation); or symptoms worsening during the entire study timeframe. A clinician working at the center on a regular basis was in charge of reporting to the research project Clinical Director any adverse effects, events, or worsening of symptoms during the study. No adverse effects or events were reported by the TG participants during the treatment procedure administration or at thirty-day follow-up. None of the participants in the TG showed clinically significant worsening/exacerbation of symptoms on the PCL-5 after treatment.

Examples of the Pathogenic Memories Treated with the ASSYST-I

Participants chose an average of five out of the fifteen traumatic events from the Trauma Screen Checklist. Examples of pathogenic memories treated during the ASSYST-I sessions were: a) Having been expelled from her house at age 8, being homeless, suffering continuous sexual rape including 10 men at the same time, and severe physical violence for years; b) having been burned on the genitals and legs with a lighter and on the back with a frying pan, and stabbed in the hand with a knife by the stepmother; c) attempted drowning in a water tank, hit with an electric cable, and burned by the stepmother; d) having been kidnapped, and for a whole year sexually abused, beaten, and her body used to test injected drugs; e) having been exploited by a sect; f) being tied to a chair and beaten by both parents.

Statistical Analysis

To analyze the effect of the ASSYST-I treatment on PTSD symptoms, analyses of variance (ANOVA) for three times repeated measurements (Time 1. Pre-treatment assessment; Time 2. Post-treatment assessment; and Time 3. Follow-up assessment), comparing Treatment group (TG) vs Control group (CG) was carried out. Eta squared (η²) is reported to show the effect sizes. Mean comparisons between and within groups using t test were conducted; Cohen´s d, is included to report the effect size.

Results

Effects on PTSD symptoms

Results showed that the intervention had a significant effect for time on PTSD symptoms (F (2,76) = 36.92 p <.000, η² = .493). A significant effect for group was also found (F (1, 38 = 32.7, p<.005, η² = .896) with a large effect, and a significant interaction between time and group, (F (2, 76) = 56.00, p <.000, η² = .600).

Mean comparisons between groups

Means comparison using t test between groups showed significant differences between the Treatment Group (TG) and the Control Group (CG) in the three time-point comparisons. For Time 1. Pre-treatment assessment (M = 55.70, SD = 10.50 vs M = 46.40, SD = 14.50), t (38) = 2.32, p<.05, d = .73, with a medium effect size. For Time 2. Post-treatment assessment. (M = 27.55, SD = 20.71 vs M = 52.00, SD = 15.74), t (38) = -4.20, p = .000, d = -1.72, with a large effect size and for Time 3. Follow-up assessment (M = 20.65, SD = 18.62 vs M = 48.95, SD = 15.46), t (38) = - 5. 22, p = .000, d = -1.65, also with a large effect size.

Mean comparisons within groups:

Intragroup means comparisons using t test for Treatment group (TG) showed significant differences between Time 1 Pretreatment assessment and Time 2. Post-treatment assessment, t (19) = 7.40, p=.000, d = .73, with a medium effect size. Comparisons between Time 2. Post-treatment assessment and Time 3 Follow-up assessment, t (19) = 2.17, p < .05, d =. 24 also showed significant differences, with a small effect size.

Intragroup means comparisons using t test for Control group (CG) showed significant differences both with a small effect size. between Time 1. Pre-treatment assessment and Time 2. Posttreatment assessment, t (19) = -2.56, p =.01, d = -.25 and between Time 2. Post-treatment assessment and Time 3. Follow-up assessment, t (19) = 3.70, p=.001, d = .13. See Table 1 and Figure 2.

*Statistically significant differences between groups with a large effect size.

Discussion

The aim of this randomized controlled trial with an intentionto- treat was to evaluate the effectiveness, efficacy, and safety of the Acute Stress Syndrome Stabilization Individual (ASSYST-I) treatment intervention in reducing posttraumatic stress disorder (PTSD) symptoms in female children polytraumatized by adverse childhood experiences, neglect, and maltreatment. A total of 40 females children met the inclusion criteria and participated in the study. Participants’ ages ranged from 8 to 17 years old (M =14.67 years). A two-arm randomized controlled trial (RCT) design was applied.

Result showed statistically significant differences between groups from the pre-treatment assessment with a lower score for PTSD symptoms for the Control group, the effect size of these differences by Time 1 was considered small according to Cohen´s calculator. However, significant differences with a large effect size were found for the Post-treatment and Follow-up assessment comparing the two groups. For the Post-treatment assessment scores had increased for the Control Group in contrast with the Treatment group, this statistically significant difference was confirmed with the large effect size obtained. These differences between groups were maintained by the follow up assessment and can be attributed to the treatment.

Regarding the Reliable Change Index (RCI), 18 out of 20 TG participants (90%) exhibited reliable change on symptom reduction with an average of 37.61 points of PTSD symptom reduction, 18-points being the more conservative value. This is indicative that the ASSYST-I treatment intervention reduced PTSD symptom severity beyond what is attributable to measurement error.

In reference to the Clinically Significant Change (CSC) margin, 14 out of 20 TG participants (70%) exhibit clinically significant change, indicating that these participants are more likely to belong to the non-PTSD population. Following our AIP & Symptom trajectory-based stepped care approach to adverse experiences, EMDR therapy was provided to the six participants that did not reach a CSC margin after the Time 3 Follow-up assessment.

Conclusion

The evidence of the detrimental mental and physical effects of ACEs, particularly child abuse, neglect, and maltreatment, has been well documented and researched, and the individual and societal negative outcomes are widely known. Prevention is the most effective and ideal approach to combating PTSD and PTSD symptoms in children and adolescents. For those who have experienced ACEs or various types of child maltreatment, vital to the health of children, and long-term health outcomes of adults is an effective and efficient (time and cost) PTSD treatment intervention that can be used with children to prevent undesirable long-term health outcomes. With the abundance of studies demonstrating the negative effects of ACEs and childhood maltreatment, there is a lack of studies with evidence for effective PTSD treatment in polytraumatized children, which is a devastating problem that does not know regional confinement, causing mental and physical health problems, at a neural and structural level, that requires high quality, evidence-based PTSD treatment interventions. This paper is intended to fill some of the gap in the lack of research and evidence for PTSD treatment interventions for polytraumatized children.

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Wednesday, February 28, 2024

Clinical Control Trial on the Healing Drawing Procedure (HDP) Trauma Treatment Intervention Provided by Non-Specialist Mental Health Providers to Vulnerable Children Living in Taraz, Republic of Kazakhstan - Juniper publishers

 Psychology and Behavioral Science- Juniper Publishers




Abstract

This clinical controlled trial had two objectives: 1) to evaluate the effectiveness, efficacy, and safety of the Healing Drawing Procedure (HDP) group trauma treatment intervention in reducing posttraumatic stress disorder (PTSD) symptoms among vulnerable children living in Taraz, Kazakhstan and 2) to explore the effectiveness and safety of non-specialist mental health providers (MHPs) being trained in and delivering the HDP group trauma treatment intervention as part of the task-sharing focused Trauma Healing Training Program (THTP), which is being developed to safely bring effective mental health treatment interventions to high-need, low-resource contexts, specifically in low-and-middle-income countries (LMICs). A total of 22 children between the ages of 7-14 (M = 10.09 years old) met the inclusion criteria and participated in the study. To evaluate the effectiveness, efficacy, and safety of the HDP treatment intervention in reducing PTSD symptoms in vulnerable children, repeated-measures ANOVA was applied, comparing the Treatment Group (TG) and the Control Group (CG). Results showed that the HDP treatment intervention had a significant effect for time, with a medium effect size (F (2,40) = 17.72 p <.000, η² = 470), and a significant effect for group with a lower effect size (F (1, 20 = 76.66, p<.001, η² = .404). Intragroup comparisons of means showed significant differences for the Treatment Group (TG) between Time 1. Pre-test assessment and Time 2. Post-treatment assessment with a large effect, t (14) = 5.42, p=.00, d = .955. These data confirm the effectiveness, efficacy, and safety of the HDP group trauma treatment intervention in reducing posttraumatic stress disorder (PTSD) symptoms in children. Results also show the Trauma Healing Training Program’s success in safely bringing an effective mental health treatment intervention provided by specially trained non-specialist mental health providers in a low-resource country.

Keywords: Healing Drawing Procedure, HDP; Posttraumatic Stress Disorder (PTSD); Non-Specialist Mental Health Providers; Low-And-Middle-Income Countries (LMIC); Adaptive Information Processing

Abbreviations: HDP: Healing Drawing Procedure; PTSD: Posttraumatic Stress Disorder; MHPs: Mental Health Providers; THTP: Trauma Healing Training Program; LMICs: Low-and-Middle-Income Countries; TG: Treatment Group; CG: Control Group; WHO: World Health Organization; ISTSS: International Society for Traumatic Stress Studies; PTs: Psychological Treatments; AIP: Adaptive Information Processing; EMDR-IGTP-OTS: Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress; CCT: Clinical Controlled Trial; EPT: Emotional Protection Team; ANOVA: Analyses of variance

Introduction

It is well established that Adverse Childhood Experiences (ACEs), (e.g., child maltreatment, abuse, neglect, witnessing domestic violence between parents) can lead to the development of posttraumatic stress disorder (PTSD) and can have a profound impact on an individual’s physical health [1-4]. Evidence also shows a dose-response relationship between ACE scores and adult physical health, as well as mental health problems. For example, Merrick et al. found that higher ACE scores increased the odds of experiencing drug and alcohol use, suicide attempts, and depressed affect in adulthood [5]. It is also known that PTSD is common and devastating disorder, that half of global cases of PTSD are considered persistent, and only a very small minority of those with severe PTSD symptoms in low-and-middle income countries (LMICs) receive specialty health care to treat the symptoms of PTSD [6]. While the long-term impacts of the effective treatment of ACEs during childhood are unknown at this time, a parallel issue to be considered is the lack of availability of mental health services in Kazakhstan, as well as globally, to provide such treatment during childhood, and even into adulthood. According to an official 2019 estimate by the United Nations, the population of Kazakhstan is 18,551,428 [7]. The Mental Health Atlas 2020, published by the World Health Organization (WHO), finds that there are an estimated 4,476 specialist mental health providers (MHPs), or mental health professionals, in Kazakhstan. Only 778 of those professionals specialize in the treatment of children and adolescents. That means that there are an estimated 24.13 specialist MHPs per 100,000 citizens resulting in only 12.10 specialist MHPs per 100,000 citizens that specialize in the care of children and adolescents [8]. The need for more available mental health services in Kazakhstan is great, to say the least.

As declared by the WHO, mental health is a basic human right [9]. Yet, like the situation in Kazakhstan, the worldwide shortage of specialist MHPs and the ever-growing gap between the availability of providers and the need for their services is widely understood. Most recently, the International Society for Traumatic Stress Studies (ISTSS) published a briefing paper advocating for increased access to psychological treatments (PTs) in the global context and called for task-sharing and the training of non-specialist MHPs to be seen as a primary source to begin narrowing the gap between the need for mental health services and the availability of such services [10]. While there continues to be much work to be done, there is a small body of evidence that task-sharing PTs can be safely and effectively administered by non-specialist mental health providers [11-15]. This study hopes to contribute to that ever-growing body of evidence.

The Trauma Healing Training Program

This study was conducted as part of the development of the Trauma Healing Training Program (THTP), which is a specialized training being developed in the vein of task-sharing as part of the solution to the global mental health care crisis, particularly in LMICs. This training is being designed to equip non-specialist MHPs with safe and effective AIP-Informed trauma processing interventions to begin narrowing the great divide between mental health services needed and mental health services available in their communities. The THTP is a two-week training that includes learning two different group interventions as well as two individual interventions. Fieldwork is conducted on all four interventions with the in-person supervision and support of the THTP trainer. Specifically, for the HDP portion of the THTP, trainees receive a two-day in-person training on the HDP which includes demonstration of the HDP, lecture including defining trauma and recognizing its impact, learning self-soothing skills, provided understanding of the window of tolerance, as well working memory theory. Besides fieldwork, the training also includes practicum within the training team, so trainees can practice the administration of the HDP on each other before providing it to participants of this research project. In-person supervision and feedback from the trainer was provided throughout the training as well as during all fieldwork. Discussions of how to make the administration of the HDP culturally successful within the Kazakh culture and the specific context of the Caring Heart Public Fund were included. Six months of virtual follow up consultation from the trainer will be provided to the training team along with continued communication with the executive director of Caring Heart as the training team continues to utilize all the intervention tools of the THTP as they work to provide much needed mental health serices to the children of Caring Heart.

AIP Theoretical Model

In her 2018 text, Shapiro describes the Adaptive Information Processing (AIP) model and posits that memory networks of stored experiences are the basis of both mental health as well as pathology across the clinical spectrum [16]. When memories are adequately processed and adaptively stored, they form the foundation for learning and future perceptions, behaviors, and responses. When memories are inadequately processed and maladaptively stored due to high autonomic nervous system arousal states produced by adverse life experiences, pathogenic memory networks are formed, resulting in present-day suffering, difficulty, and symptoms (e.g., PTSD, anxiety, depression) [16]. Shapiro’s AIP theoretical model is the basis for the development of all treatment interventions incorporated in the THTP.

Posttraumatic Stress Disorder

Posttraumatic stress disorder (PTSD) is a pervasive mental health disorder with devastating individual and societal effects, such as deterioration of basic functioning, hindrance of personal and professional relationships, and extreme psychological and physiological distress. PTSD leads to maladaptive responses that manifest in different forms, which include, but are not limited to hyperarousal, hypervigilance, flashbacks, nightmares, fear, horror, and impaired affective prosody and inability to adequately interpret emotional cues [17].

Healing Drawing Procedure Group Treatment Intervention

There are three levels to the THTP, and this study was conducted on Level 1, The Healing Drawings Procedure (HDP) Group Treatment Intervention. The HDP is modeled exclusively after the empirically based Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) developed and extensively field-tested by Jarero et al. [18-22]. Like the EMDR-IGTP-OTS, the HDP is a scripted intervention incorporating elements of art therapy and utilizes the butterfly hug method as a selfadministered bilateral stimulation [19] to process traumatic material.

Previous Treatment Intervention Studies

The EMDR-IGTP-OTS, after which the HDP is modeled, was initially developed by members of the Mexican Association for Mental Health Support in Crisis (AMAMECRISIS) when they were overwhelmed by the extensive need for mental health services after Hurricane Pauline ravaged the coasts of Oaxaca and Guerrero in 1997 [18]. While this study is the initial research project to study the effectiveness of the HDP being provided by non-specialist MHPs, there have been numerous studies showing the efficacy of the EMDR-IGTP-OTS, including with children [23- 27], and provided by frontline workers, or non-specialist MHPs [11].

Objective

This clinical controlled trial had two objectives:

i) To evaluate the effectiveness, efficacy, and safety of the Healing Drawing Procedure (HDP) group trauma treatment intervention in reducing posttraumatic stress disorder (PTSD) symptoms among vulnerable children living in Taraz, Kazakhstan.

ii) To explore the effectiveness and safety of non-specialist mental health providers (MHPs), being trained in and delivering the HDP group treatment intervention as part of the task-sharing focused, Trauma Healing Training Program (THTP).

Method

Study design

To measure the effectiveness of the HDP on the dependent variable PTSD symptoms, this study used a two-arm clinical controlled trial (CCT) with a waitlist no-treatment control group design. PTSD symptoms were measured at three-time points for all participants in the study: Time 1. Pre-treatment assessment; Time 2. Post-treatment assessment; and Time 3. Follow-up assessment. For ethical reasons, all participants in the control group received intervention treatment after the follow-up assessment was completed.

Ethics and Research Quality

Due to the lack of an Institutional Review Board in the country of the study, the research protocol was reviewed and approved by the EMDR Mexico International Research Ethics Review Board (also known in the United States of America as an Institutional Review Board) in compliance with the International Committee of Medical Journal Editors recommendations, the Guidelines for Good Clinical Practice of the European Medicines Agency (version 1 December 2016), and the Helsinki Declaration as revised in 2013.

Participants

This study was conducted between September and November 2023 in the city of Taraz, Republic of Kazakhstan, in Central Asia. A total of 22 children (12 female, 10 male) ages 7-14 (M=10.09 years old) living in Taraz, Kazakhstan, met inclusion criteria and were able to complete participation in the study. Children were recruited for this study through their involvement with Caring Heart Public Fund, a legally registered non-profit organization in Taraz, Kazakhstan, focused on meeting the needs of vulnerable children and single mothers. All the children who participated in the study came there each weekday as part of the day program in conjunction with attending local schools. Participation was voluntary, and the participants verbally consented to the treatment while a parent or legal guardian signed a written consent in accordance with the Mental Capacity Act 2005. Inclusion criteria for the participants receiving the intervention were:

a) Being a child less than 18 years old.

b) Being a participant of the programs and services offered by Caring Heart.

c) Voluntarily participating in the study.

d) Not receiving specialized trauma therapy.

e) Not receiving drug therapy for PTSD

symptoms.

Exclusion criteria were:

a) ongoing self-harm/suicidal or homicidal ideation,

b) diagnosis of schizophrenia, psychotic, or bipolar disorder,

c) diagnosis of a dissociative disorder,

d) organic mental disorder,

e) a current, active chemical dependency problem,

f) significant cognitive impairment (e.g., severe intellectual disability, dementia),

g) presence of uncontrolled symptoms due to a medical illness.

Instrument for Psychometric Evaluation

To measure PTSD symptom severity and treatment response, the optimal short-form of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) was used. This screening scale was not used to render clinical diagnoses. Rather, it was used to measure and track the severity of symptoms of PTSD in a context where the administration of the full PCL-5 was not feasible. The optimal short-form PCL-5 has been shown to detect virtually all cases meeting DSM-5 criteria of PTSD that would be detected by the full PCL-5, making it ideal for measuring and tracking symptoms of PTSD [28]. The instrument was translated and backtranslated to Russian, and the time interval for symptoms was the past week. The screening tool contains four items including:

i. Suddenly feeling or acting as if the stressful experience were happening again.

ii. Avoiding external reminders of stressful experiences.

iii. Feeling distant or cut off from other people.

iv. Irritable behavior, angry outbursts, or acting aggressively.

Respondents indicated how much they have been bothered by each PTSD symptom over the past week (rather than the past month), using a 5-point Likert scale ranging from 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. A total-symptoms score of 0 to 16 can be obtained by summing the items. The sum of the scores yields a continuous measure of PTSD symptom severity and can serve as a screen for detecting PTSD. Psychometrics for the optimal short-form PCL-5, validated against the full PCL-5, suggests that a score of 6 is the minimum to determine probable PTSD status based on DSM-5 diagnostic rules [28].

Procedure

Enrollment, Assessments, Data Collection, and Confidentiality of Data

Children were divided into a treatment group (TG) and a control group (CG) dictated by their school schedules. The children who went to school in the afternoon were available to participate in this study in the morning and vice versa. To provide the initial treatment to as many children as possible, the 15 children available in the morning (the morning group) were chosen as the treatment group as there were more children in the morning group. There were seven children available in the afternoon (the afternoon group), and so they were chosen as the control group. Which children went to school in the morning vs. the afternoon was dictated by the schedules of the school they attended. Age or educational level did not determine which school schedule each child had or their placement in the treatment or control groups. After the conclusion of all data collection for this study, for ethical reasons, the children in the control group were also provided with the same HDP intervention. For data collection Time 1, Trainees of the THTP were all trained in completing the optimal short-form PCL-5 with the children. The optimal short-form PCL- 5 was translated and back-translated into Russian as the entire training was conducted in English, with Russian translation. All trainees spoke Russian, and some trainees were also fluent in Kazakh. As each child was paired with a trainee to complete the assessments, care was taken to match Kazakh-speaking children with a Kazakh-speaking trainee and Russian-speaking children with Russian-speaking trainees. Trainees instructed the child to play a mental movie of all their difficult life experiences to identify the memory that bothered them the most. That memory was noted on the short form PCL-5 assessment paper and was used for all subsequent assessments as well as the HDP treatment intervention. Demographic information and consent forms, which also incorporated the exclusion criteria, were completed by a parent or legal guardian for each child as well.

]

For data collection, Time 2. Post-treatment, the short-form PCL-5 was completed in person with each child one week after the completion of the HDP treatment intervention. The THTP trainees reminded each child of the memory that bothered them the most before answering the instrument to ensure participants were focusing on the same adverse experience each time, they completed the assessment tool. For data collection Time 3, three-week follow-up, the optimal short-form PCL-5 assessment was conducted three weeks after treatment was completed. The assessments were completed with each child in person by the same THTP trainee that had previously conducted the assessments with each child for data collection Times 1 and 2. All data was collected, stored, and handled in full compliance with the EMDR Mexico International Research Ethics Review Board requirements to ensure confidentiality. Each study participant gave their consent to collect their data, which was strictly required for study quality control. All procedures for handling, storing, destroying, and processing data were following the Data Protection Act 2018. All people involved in this research project were subject to professional confidentiality.

Withdrawal from the Study and Missing Data

All research participants had the right to withdraw from the study without justification at any time and with assurances of no prejudicial result. If participants decided to withdraw from the study, they were no longer followed up in the research protocol. There were no withdrawals during this study.

Treatment

Participants received six administrations of the Healing Drawings Procedure (HDP) treatment intervention as a group to reprocess pathogenic memories that were an average of 51.4 months old (4.28 years old). Two administrations of the intervention were provided each day for three consecutive days, totaling six hours of treatment. All administrations of the intervention were done in Russian with Kazakh translation. A different team member from the THTP training team volunteered to administer each set of the HDP while three other team members served as the Emotional Protection Team (EPT) per the 1:5 adultto- child ratio required for the HDP intervention. The remaining team members who were not either the leader or part of the EPT observed from the back of the room. Throughout the three days, all team members served either as the leader or as an EPT member; many served in both roles.

Clinicians and Treatment Fidelity

Nine of the non-specialist MHPs participated in the THTP and were members of the training teamwork for Caring Heart. Two trainees work for a similar organization in Shymkent, Kazakhstan. Consequently, the trainees all had different roles within their organizations, including teacher, program coordinator, administrative assistant, speech therapist, house mom, and social worker. While there are professional mental health services available in Taraz, they are quite limited in general and are not specialized in treating trauma to the best of the author’s knowledge. These non-specialist MHPs successfully administered the HDP intervention to the participants as part of the fieldwork portion of the THTP. The THTP trainer, a licensed mental health professional in the United States, also an EMDRIA Approved Consultant and EMDR Basic trainer, provided the two-day HDP portion of the training in person and supervised the fieldwork as part of the overall THTP. This team of non-specialist MHPs were chosen to participate in this training and research project primarily because of their demonstrated competence as leaders and teachers and because they already have working relationships and rapport developed with the children.

Treatment Safety

Treatment safety was defined as the absence of worsening adverse effects, events, or symptoms. No adverse reactions were reported or identified during subsequent post-treatment data collections or the remainder of the THTP.

Examples of the Pathogenic Memories Treated with the HDP

Examples of pathogenic memories treated during the HDP sessions were: Being physically abused and / or neglected, witnessing domestic violence between parents or other adults, being taken to a state-run orphanage, and subsequent fear of being returned there.

Clinicians’ Experience with the HDP Treatment Intervention

While trainees initially were concerned about asking the children to focus on their disturbing memories, they were quite pleased to see the results as the children processed through the traumatic experiences as witnessed through the reduction in the identified SUD (Subjective Unit of Disturbance) as is utilized in the HDP. Trainees were particularly impressed that they could provide relief to 15 children over the course of 6 hours rather than working with them individually on simple behavior modification.

Statistical Analyses

Analyses of variance (ANOVA) for repeated measurements comparing two groups, Treatment Group (TG) vs Control Group (TG) was applied to analyze the effects of the Healing Drawings Procedure (HDP) treatment intervention across the time at threetime measurements: Time 1. Pre-treatment assessment; Time 2. Post-treatment assessment; and Time 3. Follow-up assessment. Eta squared (η²) is reported to show the effect size. Comparison of means analyses was carried out using the t-test for both independent samples and within groups. Cohen´s d is included to report the effect size for t-test results.

PTSD

Results showed that the intervention had a significant effect for time on PTSD with a medium effect size (F (2,40) = 17.72 p <.000, η² = 470), a significant effect for group with a lower effect size was observed (F (1, 20 = 76.66, p<.001, η² = .404), no significant interaction was found.). Comparison of means between groups did not show significant differences for Time 1. Pre-test assessment (M = 6.53, SD = 3.22 vs M = 9.42, SD = 3.86). For Time 2. Post-treatment assessment, significant differences between the Treatment Group (TG) and Control Group (CG) were found, with a large effect size, t (20) = - 3.78, p=.001, d = -1.72, (M = 1.73, SD = 1.62 vs M = 7.57, SD = 5.62). For Time 3 Follow-up assessment, significant differences between the Treatment Group (TG) and Control Group (CG) group were also found, with a large effect, t (20) = - 3.85, p=.001, d = - 1.37, (M = 1.53 SD = 1.68 vs M = 7.00, SD = 5.03). Intragroup comparisons of means showed significant differences for the Treatment group (TG) between Time 1. Pretest assessment and Time 2. Post-treatment assessment with a large effect, t (14) = 5.42, p=.00, d = .955. See Table 1 and Figure 1.

*Statistically significant differences between groups

Discussion

This clinical controlled trial has two objectives: 1) to evaluate the effectiveness, efficacy, and safety of the Healing Drawings Procedure (HDP) group trauma treatment intervention in reducing posttraumatic stress disorder (PTSD) symptoms in a population of vulnerable children and 2) to explore the efficacy and safety of non-specialist MHPs being trained in and conducting the HDP intervention as part of the task-sharing focused Trauma Healing Training Program (THTP) being developed. A total of 22 child participants met the inclusion criteria and participated in the study. Participants’ ages ranged from 7 to 14 years old (M = 10.09 years). The data supports the effectiveness, efficacy, and safety of the HDP group trauma treatment intervention in reducing posttraumatic stress disorder (PTSD) symptoms in children. The results of the statistical analyses showed that the HDP group treatment intervention had a significant effect for time, with a medium effect size, and a significant effect for group with a lower effect size. A comparison of means between the treatment and control groups did not find significant differences for Time 1.

Pre-test assessment and for Time 2. Post-treatment assessment showing a similar baseline. Significant differences between groups were found for Time 2. Post-treatment and for Time 3. Follow-up with a large effect size in both assessments. Intragroup analyses of means showed significant differences for the Treatment Group (TG) compared Time 1. Pre-test assessment and Time 2. Post-treatment assessment with a large effect. Scores were maintained for Time 3. Follow-up assessment in this group confirming the effect of the treatment. In reference to objective number 2, exploring the effectiveness and safety of non-specialist mental health providers (MHPs), being trained in and delivering the HDP group treatment intervention as part of the task-sharing focused Trauma Healing Training Program (THTP), the study results also show the THTP success in safely bringing an effective mental health treatment intervention provided by specially trained non-specialist mental health providers in a low-resource country.

Conclusion, Limitations, and Future Directions

PTSD is a pervasive mental health disorder that has devastating effects on individuals and society. Therefore, there is a need for evidence-based, time-limited, cost-effective, and safe interventions to enhance the treatment of posttraumatic psychopathology. This study’s results showed that the HDP group treatment intervention can effectively, efficiently, and safely be provided in person to a child population with pathogenic memories to reduce PTSD symptoms. The participants reported no adverse effects or events during the treatment intervention administration or at the three-week follow-up. None of the participants showed clinically significant worsening/exacerbation of intrusion symptoms on the short-form PCL-5. Clinicians’ reports based on their experiences also suggest that the HDP is a provider friendly treatment intervention that can be successfully applied by novice and seasoned providers alike, yielding similar treatment results, facilitating clinician confidence. Limitations of this study are the lack of randomization, the different sizes of the groups with a small sample, and the three-week follow-up. Therefore, we recommend a randomized controlled trial with a child population with pathogenic memories (e.g., adverse childhood experiences) or on PTSD Criteria-A experiences, with larger samples, and with follow-up at three or six months to evaluate the long-term treatment effects.


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