NCT02537678

Stepped Care for Children After Trauma: Optimizing Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 4 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Stepped Care TF-CBT	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
BEHAVIORAL	Standard TF-CBT	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.).

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-07-23
• Completion: 2020-07-23
• First posted: 2015-09-02
• Last updated: 2022-05-06
• Results posted: 2022-05-06

Locations

6 sites across 1 country: United States