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

Not Applicable

Recruiting

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Behavioral: Trauma Focused Cognitive Behavioral Therapy

• Registration Number: NCT06332209
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-27
• Status Verified: 2025-01
• Study Start: 2025-04-01
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinic-TF-CBT	Trauma Focused Cognitive Behavioral Therapy	Trauma-Focused Cognitive Behavioral Therapy delivered in clinic (in-person)
Tele-TF-CBT	Trauma Focused Cognitive Behavioral Therapy	Trauma-Focused Cognitive Behavioral Therapy delivered via telehealth

Primary Outcome Measures

Name	Time	Method
Traumatic Stress Symptoms	baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)	Parent and youth rated trauma symptoms will be measured via the the UCLA Post Traumatic Stress Disorder Reaction Index Interview. Scores range from 0 to 80 with higher scores indicating higher levels of post traumatic stress.

Secondary Outcome Measures

Name	Time	Method
Anxiety and Depression Symptoms	baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)	Parent and youth rated anxiety and depression symptoms will be measured via the Pediatric Symptom Checklist. Scores range from 0 to 70 with higher scores indicating higher levels of impairments.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States