Stepped Care for Children After Trauma: Optimizing Treatment
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Intervention name(s): Stepped Care TF-CBT; Standard TF-CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; 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.).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment