Stepped Care for Children After Trauma: Optimizing Treatment

Study Overview
=================
Brief Summary
-----------------
Children who are exposed to traumatic events are at risk for developing PTSD and other mental health problems. Although effective treatments for childhood PTSD exist, service delivery approaches that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The proposed study furthers our pilot work and evaluates an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to optimize treatment in community settings and improve the value and efficiency of trauma-focused treatment for children compared to existing approaches, thereby reducing childhood PTSD and related societal impacts and costs.

Detailed Description
-----------------
Approximately 68-80% of youth will experience at least one potentially traumatic event during their childhood with about one third experiencing more than one traumatic event. Exposure to traumatic events markedly elevates the risk of developing posttraumatic stress disorder (PTSD) and associated impairment. Despite advances in effective trauma-focused treatments for children, the lack of efficient, accessible, personalized, and cost-effective trauma treatment for children is a major public health concern. Thus, there is a critical need for interventions to improve efficiency, access, and cost-effectiveness and to offer tailored approaches that meet the unique needs of the child. The present study builds on the investigators NIH-funded pilot work (1R34MH092373-01A1) that developed an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT). The purpose of the proposed study is to examine how to optimize the efficiency (e.g., via matching children to appropriate treatment dosage at baseline, utilizing second-stage tailoring variables, and identifying mechanisms of change) and cost-effectiveness of Stepped Care TF-CBT. The long-term goal is to develop an effective, efficient, accessible, and cost-effective adaptive Stepped Care TF-CBT intervention that can be available to more trauma-exposed children, and to advance knowledge about service delivery approaches that may be applicable to providing treatment for other childhood mental health disorders. The goal of the study is consistent with the strategic objective to Develop New and Better Interventions that Incorporate the Diverse Needs and Circumstances of People with Mental Illness, and the research priorities that call for trials that foster prescriptive, personalized mental health care, incorporate tailoring variables to match patient interventions, improve access to services, decrease costs of services, and incorporate measures of putative mechanisms of action in trials in real world settings. In a randomized clinical trial with 216 children ages 4 to 12 years at community-based agencies, the following aims are proposed: Aim 1: To examine Stepped Care TF-CBT (e.g., starting with Step One parent-led, therapist-assisted treatment and then either maintenance or Step Two TF-CBT) relative to standard TF-CBT (e.g., therapist-led treatment); Aim 2: To examine tailoring variables that could be used to individualize (i.e., tailor) the decision of which children should be assigned at baseline to Stepped Care TF-CBT versus standard TF-CBT; Aim 3: To examine if changes in the potential mechanisms of change variables (e.g., fear arousal, maladaptive cognitions, negative expectancy, and fear toleration) mediate treatment on child PTSD symptoms (PTSS) and impairment; Aim 4: To examine the economic cost of delivering Stepped Care TF-CBT versus standard TF-CBT. Children with PTSD are at considerable risk for numerous biopsychosocial problems. Without accessible, effective treatment, these problems tend to persist into adulthood. This study will yield clinically important data which will improve the value and efficiency of treatment of children with PTSD, thereby reducing childhood PTSD and related societal impacts and costs.

Official Title
-----------------
Stepped Care for Children After Trauma: Optimizing Treatment

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Stepped Care TF-CBT
* Behavioral: Standard TF-CBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Parent/Guardian-child dyads enrolled. Inclusion Criteria: Child experienced at least one traumatic event after the age of 36 months Child age 4-6 must meet at least four PTSD symptoms and children age 7 to 12 must meet at least five PTSD symptoms with at least one symptom in re-experiencing or one symptom in avoidance At enrollment, the child must be between 4-12 years of age The parent/guardian must be willing and able to participate in the treatment and complete informed consent Exclusion Criteria: Psychosis, mental retardation, autism spectrum disorder in the child or any condition that would limit the caregiver's ability to understand CBT and the child's ability to follow instructions Parent has had substance use disorder (SUD) within the past 3 months. Child or parent is suicidal Child or parent is not fluent in English Child is currently taking psychotropic medication and is not on a stable medication regimen for at least 4 weeks prior to admission to the study. For stimulants or benzodiazepines, the medication regimen must be stable for 2 weeks. If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage the child may be enrolled in the study. Child is receiving trauma-focused psychotherapy during study treatment. Parent/caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home Child is having unsupervised face-to-face contact with the identified perpetrator Siblings

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stepped Care TF-CBT<br>Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. | Behavioral: Stepped Care TF-CBT<br>* Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks<br>|
| Active Comparator: Standard TF-CBT<br>Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. | Behavioral: Standard TF-CBT<br>* Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms. | Post treatment | 
| Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms. | 6-month Follow up | 
| Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms. | 12-month follow up | 
| Child Sheehan Disability Scale Parent Version | The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment. | Post treatment | 
| Child Sheehan Disability Scale Parent Version | The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment. | 6-month follow up | 
| Child Sheehan Disability Scale Parent Version | The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment. | 12-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Behavior Checklist Internalizing Symptoms | Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms. | Post treatment | 
| Child Behavior Checklist Internalizing Symptoms | Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms. | 6-month follow up | 
| Child Behavior Checklist Internalizing Symptoms | Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms. | 12-month follow up | 
| Child Behavior Checklist Externalizing Symptoms | Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems. | Post treatment | 
| Child Behavior Checklist Externalizing Symptoms | Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems. | 6-month follow up | 
| Child Behavior Checklist Externalizing Symptoms | Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems. | 12-month follow up | 
| Clinical Global Impression-Severity (CGI-S) | The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity. | Post treatment | 
| Clinical Global Impression-Severity (CGI-S) | The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity. | 6-month assessment | 
| Clinical Global Impression-Severity (CGI-S) | The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity. | 12-month follow up | 
| Clinical Global Impression-Improvement (CGI-I) | The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response. | Post treatment | 
| Clinical Global Impression-Improvement (CGI-I) | The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response. | 6-month treatment | 
| Clinical Global Impression-Improvement (CGI-I) | The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response. | 12-month follow up |