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

Medical University of South Carolina (MUSC)

Status: Not yet enrolling

Conditions: Post-Traumatic Stress Disorder

Treatments: Behavioral: Trauma Focused Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06332209

U66RH31458 (Other Grant/Funding Number)

Pro00135303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Tele-TF-CBT

Active Comparator group

Description:

Trauma-Focused Cognitive Behavioral Therapy delivered via telehealth

Treatment:

Behavioral: Trauma Focused Cognitive Behavioral Therapy

Clinic-TF-CBT

Active Comparator group

Description:

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

Treatment:

Behavioral: Trauma Focused Cognitive Behavioral Therapy