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Clinical Trials/NCT06332209
NCT06332209
Recruiting
Not Applicable

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

Medical University of South Carolina1 site in 1 country80 target enrollmentApril 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Traumatic Stress Disorder
Sponsor
Medical University of South Carolina
Enrollment
80
Locations
1
Primary Endpoint
Traumatic Stress Symptoms
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2025
End Date
September 30, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Regan Stewart

Associate Professor-Faculty

Medical University of South Carolina

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

Outcomes

Primary Outcomes

Traumatic Stress Symptoms

Time Frame: 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 Outcomes

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

Study Sites (1)

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