Stepped Care for Children After Trauma: Optimizing Treatment

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.

Inclusion Criteria:

1. Child experienced at least one traumatic event after the age of 36 months

2. Child must meet at least five PTSD symptoms with at least one symptom in
re-experiencing and avoidance

3. Child has functional impairment

4. At enrollment, the child must be between 4-12 years of age

5. The parent/guardian must be willing and able to participate in the treatment and
complete informed consent

Exclusion Criteria:

1. 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

2. Parent has had substance use disorder (SUD) within the past 3 months.

3. Child or parent is suicidal

4. Child or parent is not fluent in English

5. 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.

6. Child is receiving trauma-focused psychotherapy during study treatment.

7. Parent/caregiver who would be treatment participant was the perpetrator, or the child
was perpetrated by a person who still lives in the home

8. Child is having unsupervised face-to-face contact with the identified perpetrator

9. Siblings