Recruiting

Tele-TF-CBT

Sponsor:

Medical University of South Carolina

Code:

NCT06332209

Conditions

Post-Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

Interventions

Trauma Focused Cognitive Behavioral Therapy

Study Details

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

Study ID

NCT06332209

Start date

Apr 1, 2025

Status verified date

Apr, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

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

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

Trauma Focused Cognitive Behavioral Therapy

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

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) ]
  • 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 and Locations

Central contacts

Regan Stewart, PhD

843-792-4195stewartr@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

More Information

Sponsor

Medical University of South Carolina

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • trauma focused cognitive behavioral therapy
  • telehealth
  • community implementation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-04-23.