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NCT06332209 | Not yet recruiting | Post-Traumatic Stress Disorder


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

Medical University of South Carolina

Information provided by (Responsible Party):

Regan Stewart

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.

Condition or disease

Post-Traumatic Stress Disorder

Intervention/treatment

Trauma Focused Cognitive Behavioral Therapy

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 80 participants
Masking : Single
Primary Purpose : Treatment
Official Title : Addressing Barriers to Care Among Underserved Youth: Telehealth Delivery of Trauma-Focused Cognitive Behavioral Therapy - A Randomized Effectiveness-Implementation Trial
Actual Study Start Date : June 1, 2024
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025
Arm Intervention/treatment

Active Comparator: Tele-TF-CBT

Trauma-Focused Cognitive Behavioral Therapy delivered via telehealth

Behavioral: Trauma Focused Cognitive Behavioral Therapy

Active Comparator: Clinic-TF-CBT

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

Behavioral: Trauma Focused Cognitive Behavioral Therapy

Ages Eligible for Study: 7 Years to 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

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

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