Post-Traumatic Stress DisorderNCT06332209
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
A study testing Trauma Focused Cognitive Behavioral Therapy in people with Post-Traumatic Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Trauma Focused Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 7-18 years old
- experienced at least one traumatic event
- present with clinically significant levels of post-traumatic stress symptoms
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Regan Stewart, PhD
About this study
Official title: Addressing Barriers to Care Among Underserved Youth: Telehealth Delivery of Trauma-Focused Cognitive Behavioral Therapy - A Randomized Effectiveness-Implementation Trial
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Trauma Focused Cognitive Behavioral Therapy
- Keywords
- trauma focused cognitive behavioral therapy, telehealth, community implementation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Focused Cognitive Behavioral TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Tele-TF-CBT | Active comparator | Trauma-Focused Cognitive Behavioral Therapy delivered via telehealth Receives: Behavioral: Trauma Focused Cognitive Behavioral Therapy |
| Clinic-TF-CBT | Active comparator | Trauma-Focused Cognitive Behavioral Therapy delivered in clinic (in-person) Receives: Behavioral: Trauma Focused Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traumatic Stress Symptoms
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.
Measured: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)
Traumatic Stress Symptoms
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.
Measured: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)
Secondary outcomes (2)
Anxiety and Depression Symptoms
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.
Measured: baseline, post-treatment, 3-month follow-up
Anxiety and Depression Symptoms
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.
Measured: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Apr 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332209
- Sponsor's protocol ID
- Pro00135303
- Other IDs
- U66RH31458
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Barriers to Care Among Underserved Youth: Telehealth Delivery of Trauma-Focused Cognitive Behavioral Therapy - A Randomized Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT06332209
- Acronym / sponsor ID
- Pro00135303
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- trauma focused cognitive behavioral therapy, telehealth, community implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-TF-CBT | Active comparator | Behavioral: Trauma Focused Cognitive Behavioral TherapyTrauma-Focused Cognitive Behavioral Therapy delivered via telehealth |
| Clinic-TF-CBT | Active comparator | Behavioral: Trauma Focused Cognitive Behavioral TherapyTrauma-Focused Cognitive Behavioral Therapy delivered in clinic (in-person) |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 7-18 years old
- experienced at least one traumatic event
- present with clinically significant levels of post-traumatic stress symptoms
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Focused Cognitive Behavioral TherapyTrauma-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 | Behavioural | Clinic-TF-CBT, Tele-TF-CBT |
Primary outcome
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.
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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Focused Cognitive Behavioral Therapy in people with Post-Traumatic Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regan Stewart, PhD (843-792-4195, stewartr@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traumatic Stress Symptoms (time frame: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.