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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06332209
Enrollment
80
Registered
2024-03-27
Start date
2025-04-01
Completion date
2026-09-30
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorder

Keywords

trauma focused cognitive behavioral therapy, telehealth, community implementation

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.

Interventions

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

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Traumatic Stress Symptomsbaseline, 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 Child Post Traumatic Stress Disorder Symptoms Scale. Scores range from 0 to 80 with higher scores indicating higher levels of post traumatic stress.

Secondary

MeasureTime frameDescription
Anxiety and Depression Symptomsbaseline, post-treatment, 3-month follow-upParent and youth rated anxiety and depression symptoms will be measured via the Revised Child Anxiety and Depression Scale Short form.Scores range from 0 to 75 with higher scores indicating higher levels of anxiety and depression.

Countries

United States

Contacts

CONTACTRegan Stewart, PhD
stewartr@musc.edu843-792-4195

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026