Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trauma Focused Cognitive Behavioral Therapy.
- Who it may be relevant to
- Registry conditions: Post-Traumatic Stress Disorder. Basic parameters: 7 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Addressing Barriers to Care Among Underserved Youth: Telehealth Delivery of Trauma-Focused Cognitive Behavioral Therapy - A Randomized Effectiveness-Implementation Trial
Overview
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
- Behavioral Trauma Focused Cognitive Behavioral Therapy
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 outcome measures
- Traumatic Stress Symptoms [Time frame: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)]
- Traumatic Stress Symptoms [Time frame: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)]
Secondary outcome measures (2)
- Anxiety and Depression Symptoms [Time frame: baseline, post-treatment, 3-month follow-up]
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT06332209 · Pro00135303 · U66RH31458