- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07682441
CBITS-RTM Pilot Study
2 juli 2026 uppdaterad av: University of California, San Francisco
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.
Studieöversikt
Status
Har inte rekryterat ännu
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
28
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Johanna B Folk, PhD
- Telefonnummer: 415-602-9521
- E-post: johanna.folk@ucsf.edu
Studera Kontakt Backup
- Namn: Jeanne McPhee, PhD
- E-post: jeanne.mcphee@ucsf.edu
Studieorter
-
-
California
-
San Francisco, California, Förenta staterna, 94131
- UCSF Zuckerberg San Francisco General Hospital
-
Kontakt:
- Principal Investigator, PhD
- E-post: johanna.folk@ucsf.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- 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..
Exclusion Criteria:
- Observable cognitive or developmental delays or active psychosis that would interfere with completing consent, assessment or intervention.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Adapted CBITS-RTM Intervention
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Child PTSD Symptom Scale (CPSS)
Tidsram: 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.
|
Baseline, 3 months post-baseline
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Youth Alcohol and Drug Use Survey
Tidsram: Baseline, 3 months post-baseline
|
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).
|
Baseline, 3 months post-baseline
|
|
Texas Christian University (TCU) Drug Screen
Tidsram: Baseline, 3-months post-baseline
|
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.
|
Baseline, 3-months post-baseline
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Youth Background Characteristics
Tidsram: Baseline
|
Demographics questionnaire used to gather standard demographics (e.g., age, gender, race) and information such as state agency involvement (e.g., age at first contact with juvenile legal system, number of prior arrests), immigration status.
|
Baseline
|
|
Treatment Acceptability Form
Tidsram: 3-months post-baseline
|
This form will be used to assess the acceptability of the adapted CBITS-RTM intervention.
Items are scored from 1 "Strongly disagree" to 5 "Strongly agree."
Scores range from 10-50 with higher scores indicating higher acceptability.
|
3-months post-baseline
|
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CBITS-RTM Group Evaluation Posttest
Tidsram: 3-months post-baseline
|
This will assess knowledge of trauma, changes in ability to cope with stress, and acceptability of the intervention and its delivery.
Items are true/false or qualitative in nature.
|
3-months post-baseline
|
|
Clinician personal and professional background characteristics
Tidsram: Baseline
|
Questionnaire used to gather personal and professional background characteristics (e.g., clinical discipline, experience with trauma treatment, years of practice in juvenile detention setting).
|
Baseline
|
|
Cognitive Behavioral Intervention for Trauma in Schools-Fidelity Adherence Measure 2.0
Tidsram: 20% of the sessions
|
This measure will be used to assess how closely clinicians adhere to the adapted CBITS-RTM intervention.
The scale describes the core components expected to be covered in each session, and the rater indicates the degree to which each component was delivered with fidelity using a 4-point item rating ranging from 0 (not covered at all) to 3 (covered thoroughly).
Higher item scores indicate greater fidelity to the intervention curriculum.
|
20% of the sessions
|
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The Evidence-Based Practice Attitude Scale (EBPAS)
Tidsram: Baseline
|
The EBPAS (15-items) will be used to assess clinician's attitudes toward adopting new evidence-based practices (EBPs).
It consists of four subscales: appeal, requirements, openness, and divergence.
Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (to a very great extent).
Higher scores on the Appeal, Requirements, and Openness subscales indicate more positive attitudes toward adopting EBPs, whereas higher Divergence scores indicate less favorable attitudes.
|
Baseline
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Johanna Folk, PhD, University of California, San Francisco
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
30 juni 2027
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
26 juni 2026
Först inskickad som uppfyllde QC-kriterierna
26 juni 2026
Första postat (Faktisk)
2 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25-45799
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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