PTSD - Post Traumatic Stress DisorderNCT07682441
CBITS-RTM Pilot Study
A study testing Adapted Cognitive Behavioral Intervention for Trauma in Schools (CBITS) with a Racial Trauma Module (RTM) in people with PTSD - Post Traumatic Stress Disorder and Substance Use, run by University of California, San Francisco at 1 site in United States.
Trial summary
This pilot study, conducted in partnership with juvenile detention centers, evaluates an adapted CBITS-RTM intervention delivered in a detention school setting. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, Substance Use
- What is being tested?
- Adapted Cognitive Behavioral Intervention for Trauma in Schools (CBITS) with a Racial Trauma Module (RTM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Dec 2027
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Youth must 1) be currently incarcerated in a partnering juvenile detention center, 2) be between 13-18 years of age, and 3) have a minimum of 3 months remaining on their sentence (i.e., sufficient time required to complete CBITS-RTM). Youth will complete a screening with a study team member involving the 2-item Abbreviated PTSD Checklist-Civilian version, with scores ≥4 considered a positive screen
- Clinicians are eligible if they are behavioral health staff working with youth at the detention school..
Who cannot join
- Observable cognitive or developmental delays or active psychosis that would interfere with completing consent, assessment or intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jeanne McPhee, PhD contact
United States1 site
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, 94131
Principal Investigator, PhD, johanna.folk@ucsf.edu
About this study
Official title: Preventing Substance Use Among Incarcerated Youth Through Addressing Posttraumatic Stress
This pilot study, conducted in partnership with juvenile detention centers, evaluates an adapted CBITS-RTM intervention delivered in a detention school setting.
Read the detailed description
The study examines the intervention's feasibility and acceptability, as well as its effectiveness in reducing incarcerated youth's posttraumatic stress symptoms, improving academic functioning, and decreasing intentions to use substances post-release.
- Being tested
- Adapted Cognitive Behavioral Intervention for Trauma in Schools (CBITS) with a Racial Trauma Module (RTM)
- Keywords
- Incarcerated youth, Juvenile detention school, CBITS-RTM
- Medical subject headings
- Combat Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Cognitive Behavioral Intervention for Trauma in Schools (CBITS) with a Racial Trauma Module (RTM)Behavioural
Also called CBITS-RTM
The Cognitive Behavioral Intervention for Trauma in Schools (CBITS) program is a school-based, group and individual intervention designed to reduce symptoms of post-traumatic stress disorder (PTSD), depression, and behavioral problems, and to improve functioning, grades and attendance, and coping skills. The CBITS intervention was adapted to juvenile justice settings with an added Racial Trauma Module (RTM), which provides youth with an overview of the effects of racism on levels of traumatic stress.
| Study group | Role | What they receive |
|---|---|---|
| Adapted CBITS-RTM Intervention | Experimental | Not described Receives: Behavioral: Adapted Cognitive Behavioral Intervention for Trauma in Schools (CBITS) with a Racial Trauma Module (RTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child PTSD Symptom Scale (CPSS)
The CPSS is used to measure posttraumatic stress among youth (8-18 years). It assesses past month posttraumatic stress symptom severity and impairment of endorsed symptoms on daily functioning. Scores range from 0-80, with 31+ indicating probable PTSD.
Measured: Baseline, 3 months post-baseline
Secondary outcomes (2)
Youth Alcohol and Drug Use Survey
The Youth Alcohol and Drug Use Survey will be used to gather youth's intention to use substances post-release using items rated on a scale from 1 (unlikely) to 10 (very likely).
Measured: Baseline, 3 months post-baseline
Texas Christian University (TCU) Drug Screen
The TCU will be administered to gather information on substance use quantity and frequency as well as risk for SUD (corresponds with DSM-5 criteria) on the 3-months prior to incarceration and past 3 months at post-release.
Measured: Baseline, 3-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johanna Folk, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682441
- Sponsor's protocol ID
- 25-45799
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Substance Use Among Incarcerated Youth Through Addressing Posttraumatic Stress
- ClinicalTrials.gov ID
- NCT07682441
- Acronym / sponsor ID
- 25-45799
- Keywords
- Incarcerated youth, Juvenile detention school, CBITS-RTM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jul 2026 (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.
This pilot study, conducted in partnership with juvenile detention centers, evaluates an adapted CBITS-RTM intervention delivered in a detention school setting.
Detailed description
The study examines the intervention's feasibility and acceptability, as well as its effectiveness in reducing incarcerated youth's posttraumatic stress symptoms, improving academic functioning, and decreasing intentions to use substances post-release.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adapted CBITS-RTM Intervention | Experimental | Behavioral: Adapted Cognitive Behavioral Intervention for Trauma in Schools (CBITS) with a Racial Trauma Module (RTM) |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Youth must 1) be currently incarcerated in a partnering juvenile detention center, 2) be between 13-18 years of age, and 3) have a minimum of 3 months remaining on their sentence (i.e., sufficient time required to complete CBITS-RTM). Youth will complete a screening with a study team member involving the 2-item Abbreviated PTSD Checklist-Civilian version, with scores ≥4 considered a positive screen
- Clinicians are eligible if they are behavioral health staff working with youth at the detention school..
Key exclusion criteria (1 listed)
- Observable cognitive or developmental delays or active psychosis that would interfere with completing consent, assessment or intervention.
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 |
|---|---|---|
| Adapted Cognitive Behavioral Intervention for Trauma in Schools (CBITS) with a Racial Trauma Module (RTM)Also: CBITS-RTMThe Cognitive Behavioral Intervention for Trauma in Schools (CBITS) program is a school-based, group and individual intervention designed to reduce symptoms of post-traumatic stress disorder (PTSD), depression, and behavioral problems, and to improve functioning, grades and attendance, and coping skills. The CBITS intervention was adapted to juvenile justice settings with an added Racial Trauma Module (RTM), which provides youth with an overview of the effects of racism on levels of traumatic stress. | Behavioural | Adapted CBITS-RTM Intervention |
Primary outcome
Child PTSD Symptom Scale (CPSS)
Time frame: Baseline, 3 months post-baseline
The CPSS is used to measure posttraumatic stress among youth (8-18 years). It assesses past month posttraumatic stress symptom severity and impairment of endorsed symptoms on daily functioning. Scores range from 0-80, with 31+ indicating probable PTSD.
2 secondary outcomes
Youth Alcohol and Drug Use Survey
Time frame: Baseline, 3 months post-baseline
Texas Christian University (TCU) Drug Screen
Time frame: Baseline, 3-months post-baseline
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 6 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for PTSD - Post Traumatic Stress Disorder
Not yet recruiting
FUS Neuromodulation for PTSD
Post Traumatic Stress Disorder PTSD
Recruiting
Evaluating Evidenced Based Options for PTSD Treatment
PTSD - Post Traumatic Stress Disorder
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
Recruiting
PTSD Screening in Pregnant Black Women
Pregnancy Early, PTSD
Not yet recruiting
Salience Network Informed rTMS for PTSD
Stress Disorders, Post-Traumatic
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.
Jeanne McPhee, PhD contact
Johanna Folk, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Cognitive Behavioral Intervention for Trauma in Schools (CBITS) with a Racial Trauma Module (RTM) in people with PTSD - Post Traumatic Stress Disorder and Substance Use, run by University of California, San Francisco 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 6 Jul 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 Johanna B Folk, PhD (415-602-9521, johanna.folk@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child PTSD Symptom Scale (CPSS) (time frame: Baseline, 3 months post-baseline). 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 6 Jul 2026.