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NCT Number: NCT06332209

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

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Regan Stewart, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

  2. 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

  1. Anxiety and Depression Symptoms

    Time frame: baseline, post-treatment, 3-month follow-up

    Parent 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.

  2. Anxiety and Depression 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 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Regan Stewart, PhD

CONTACT

[email protected]

843-792-4195

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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