Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT)

Summary

One of the most common and widely disseminated trauma treatments is Trauma Focused Cognitive Behavioral Therapy (TF-CBT). TF-CBT is a therapist-led, structured and sequential intervention, with treatment organized around P.R.A.C.T.I.C.E. (Psychoeducation, Parent training, Relaxation, Affective Regulation, Cognitive Coping, Trauma Narrative, In-Vivo Exposure, Cognitive Reprocessing, and Enhancing Safety) components. Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT) is an alternative delivery system that incorporates the best available evidence on the treatment of childhood Post-traumatic Stress Disorder (PTSD) within a stepped care model and utilizes task-shifting with caregiver involvement, which engages caregivers in actively helping their children. Stepped care approaches are characterized by a personalized approach to care in which a lower intensity (i.e., fewer number of sessions) intervention is initially provided before the child is reevaluated or ''stepped up'' for additional care should symptoms persist. The goal of this study is to assess a personalized modification of SC-CBT-CT for Latino families (pSC-CBT-CT). The hypothesis is that personalizing SC-CBT-CT will improve outcomes for Latino children.

Conditions

• Trauma
• Posttraumatic Stress Disorder

Interventions

BEHAVIORAL

Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)

The SC-CBT-CT intervention in this study is a data driven, stakeholder-informed revision of SC-CBT-CT that incorporates Latino specific values and beliefs, that is, personalized SC-CBT-CT (pSC-CBT-CT). The intervention consists of two steps utilizing Cognitive Behavioral Therapy (CBT). Step one (Stepping Together for Children after Trauma, SC-CT) involves a caregiver-led, therapist-assisted first step with narrative, imaginal, and exposure therapy, and step two consists of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), which utilizes gradual exposure. SC-CT includes three therapist-led caregiver-child meetings over 6-9 weeks, with brief weekly phone support (10-15 minutes) from the therapist to caregiver. During 11 home-based, caregiver-led meetings, the child and caregiver work together on therapeutic tasks (i.e., exposure tasks, a trauma narrative, and in-vivo exposure reminders) guided by an empirically supported activity book.

BEHAVIORAL

Treatment as Usual (TAU)

Participants in the TAU condition will be given a list of community resources offering child mental health services for trauma survivors. TAU will likely be Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) or another trauma-informed psychotherapy, which may include similar components.

Sponsors & Collaborators

• Texas Child Mental Health Care Consortium

  collaborator UNKNOWN

• Baylor College of Medicine

  collaborator OTHER

• University of South Florida

  collaborator OTHER

• University of Houston

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Leslie K Taylor, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-06-01

Completion

2027-08-31

Countries

• United States

Study Locations