Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06332209
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Trauma Focused Cognitive Behavioral Therapy — BEHAVIORAL
    Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT; Cohen et al., 2017) is an evidence-based, manualized treatment protocol designed to treat posttraumatic stress and co-occurring symptoms such as depression and anxiety in trauma-exposed children and youth and their supportive and non-offending caregivers. TF-CBT is divided into nine cognitive and behavioral components, all of which incorporate gradual exposure to trauma memories and reminders

Study Details

The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery.

Key Dates

Start date
Apr 1, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Active Comparator: Tele-TF-CBT
    Trauma-Focused Cognitive Behavioral Therapy delivered via telehealth
  • Active Comparator: Clinic-TF-CBT
    Trauma-Focused Cognitive Behavioral Therapy delivered in clinic (in-person)

Primary Outcome Measure

Traumatic Stress Symptoms [ Time Frame: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Regan Stewart, PhD

Find similar trials in Charleston, SC

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Medical University of South Carolina· Charleston, SC

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