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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07396974
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - 14 Years
Healthy Volunteers
Accepted

Interventions

  • Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) — BEHAVIORAL
    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.
  • Treatment as Usual (TAU) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Jan 2026
Primary completion
Jun 1, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index (RI) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (UCLA-RI-5) - Child Reported [ Time Frame: baseline, week 7, week 15 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77054
Leslie K Taylor, PhD
[email protected]
713-486-2728

Find similar trials in Houston, TX

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
The University of Texas Health Science Center at Houston· Houston, TX

Related Studies