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

NCT06332209 · Medical University of South Carolina

Recruiting

In plain English

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Official title

Addressing Barriers to Care Among Underserved Youth: Telehealth Delivery of Trauma-Focused Cognitive Behavioral Therapy - A Randomized Effectiveness-Implementation Trial

About this study

The current study will use a randomized controlled trial to examine telehealth delivery of Trauma Focused-Cognitive Behavioral Therapy (TF-CBT) for youth with trauma symptoms receiving care in community based clinics in Puerto Rico. First, the effectiveness of Tele-TF-CBT in improving trauma symptoms will be examined compared with clinic-based TF-CBT. Next, the feasibility, acceptability, and engagement outcomes of Tele-TF-CBT will be examined in this population. Lastly, implementation factors will be explored.

Eligibility criteria

Inclusion Criteria: * 7-18 years old * experienced at least one traumatic event * present with clinically significant levels of post-traumatic stress symptoms Exclusion Criteria: * significant suicidal ideation * substance use disorder * active psychotic symptoms * pervasive developmental delays, * currently living with or in close contact with the perpetrator of their abuse

Study design

Enrollment target: 80 participants

Allocation: randomized

Masking: single

Age groups: child, adult

Timeline

Starts: 2025-04-01

Estimated completion: 2026-09-30

Last updated: 2025-05-23

Interventions

Behavioral: Trauma Focused Cognitive Behavioral Therapy

Primary outcomes

• Traumatic Stress Symptoms (baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment))
• Traumatic Stress Symptoms (baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment))

Sponsor

Medical University of South Carolina · other

Contacts & investigators

ContactRegan Stewart, PhD · contact · stewartr@musc.edu · 843-792-4195

All locations (1)

Medical University of South CarolinaRecruiting

Charleston, South Carolina, United States

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