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

NCT06332209 | Recruiting

• 2 other identifiers: Pro00135303U66RH31458
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

trauma focused cognitive behavioral therapy; telehealth; community implementation

Outcome Measures

Primary Outcomes (2)

• Traumatic Stress Symptoms

  Parent and youth rated trauma symptoms will be measured via the Child Post Traumatic Stress Disorder Symptoms Scale. Scores range from 0 to 80 with higher scores indicating higher levels of post traumatic stress.

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

• Traumatic Stress Symptoms

  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.

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

Secondary Outcomes (2)

• Anxiety and Depression Symptoms

  baseline, post-treatment, 3-month follow-up

• Anxiety and Depression Symptoms

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

Study Arms (2)

Tele-TF-CBT

ACTIVE COMPARATOR

Trauma-Focused Cognitive Behavioral Therapy delivered via telehealth

Behavioral: Trauma Focused Cognitive Behavioral Therapy

Clinic-TF-CBT

ACTIVE COMPARATOR

Trauma-Focused Cognitive Behavioral Therapy delivered in clinic (in-person)

Behavioral: Trauma Focused Cognitive Behavioral Therapy

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

Clinic-TF-CBT; Tele-TF-CBT

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• experienced at least one traumatic event
• present with clinically significant levels of post-traumatic stress symptoms

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Regan Stewart, PhD

CONTACT

843-792-4195; stewartr@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 27, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)