- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06132282
The Substance Use and Health Risk Intervention (SUHRI) for Justice-involved Youth (SUHRI)
November 30, 2023 updated by: DanicaKnight, Texas Christian University
This investigation will adapt and pilot test an integrated health risk-reduction and motivational enhancement intervention for Juvenile Justice (JJ) youth that will ultimately be (after full testing through a subsequent large-scale RCT) a sustainable intervention implemented within a JJ supervision/case management context to teach and facilitate positive, pro-social, and expected behaviors.
The intervention will use graphical approaches to encourage introspection and problem identification, enhance self-regulation, improve analytical problem-solving skills, and promote healthy behaviors in two inter-related target areas: substance use and risky sex practices.
Existing evidence-based intervention materials will be incorporated and delivered through a web-based application.
Sessions will be self-directed (require minimal instruction/interaction assistance), and also include a service referral piece whereby youth are provided with a list of treatment and health agencies at the end of sessions that address specific topics.
Research activities will be carried out in two pilot studies: (1) Intervention Adaptation and Feasibility and (2) Protocol Feasibility and Preliminary Efficacy Trial.
In Pilot 1, intervention content will be adapted from existing evidence-based interventions so that it is developmentally appropriate for the target population and suitable for a web-based format (N = 30; 20 youth, 10 JJ staff).
Pilot 2 will test a scaled-down version of an intervention efficacy randomized control trial (RCT), comparing the web-based intervention to a time-matched, information-only group using a 2-arm, randomized design whereby 120 enrolled youth (who meet eligibility requirements) from one juvenile probation department are randomly assigned to condition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A 1-arm design was used to examine preliminary efficacy of the adapted intervention.
Youth aged 14 to 18 who are disposed to community supervision (deferred adjudication or probation) and meet eligibility requirements (1+ indicator of substance use, under community supervisions, English-speaking, no indication of suicide risk or thought disorder) were sampled from a large urban Texas juvenile probation department.
Protocol administration was proctored by a TCU research assistant at a private space within a juvenile justice office or mutually agreed upon location of participant's choosing.
Youth were asked to complete all assessments and participate in the 4 individualized technology-based intervention sessions where youth received information and engaged in decision making scenario-based games about substance use, sex risk practices, and related health-risk.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Fort Worth, Texas, United States, 76109
- Texas Christian University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- on community supervision (e.g., deferred adjudication or probation), 1+ indicator of SU, English-speaking,
Exclusion Criteria:
- no indication of suicide risk or thought disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Substance Use and Health Risk Intervention (SUHRI)
A technology-based application (administered via tablet) that addresses the interrelated topics of substance use and risky sex practices, within the context of personal relationships.
|
Technology-based intervention designed as 4 sessions administered on a tablet as a self-directed approach (requiring an onsite proctor) for addressing factors that increase risk for significant health problems.
Topics such as SU and risky sex are important but often sensitive or difficult for juvenile justice staff to address in their role as probation officers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
problem recognition
Time Frame: Baseline, Week 7, Week 15
|
The proximal outcome, problem recognition (acknowledging that SU is causing problems with family, school, health), is a continuous measure and will come from the TCU MOT.
|
Baseline, Week 7, Week 15
|
decision making
Time Frame: Baseline, Week 7, Week 15
|
The proximal outcome, decision making (considering causes and consequences of actions), is a continuous measure and will be elicited using the TCU PSY form.
|
Baseline, Week 7, Week 15
|
intention to reduce personal risk
Time Frame: Baseline, Week 7, Week 15
|
The proximal outcome, intention to reduce health risk(confidence in ability to abstain from SU), is a continuous measure and will come from the TCU THK.
|
Baseline, Week 7, Week 15
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service initiation
Time Frame: Baseline, Week 7, Week 15
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The proximal outcome, service utilization, will be a dichotomous measure consisting of information obtained through existing records (initiated SU, Yes or No; initiated health services, Yes or No).
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Baseline, Week 7, Week 15
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substance use
Time Frame: Baseline, Week 7, Week 15
|
The distal outcome, substance use, will be elicited using the Timeline Follow Back (calendar function) and will result in frequency of use during specific (3-month) time frames.
Self-report will be corroborated using positive urinalysis tests.
|
Baseline, Week 7, Week 15
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sexual/STI health risk
Time Frame: Baseline, Week 7, Week 15
|
The distal outcome, sexual/STI risk will include frequency of self-reported unprotected intercourse, use of condoms, and conversations with partners about STI risk in the past 3 months.
|
Baseline, Week 7, Week 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2022
Primary Completion (Actual)
July 27, 2023
Study Completion (Actual)
July 27, 2023
Study Registration Dates
First Submitted
November 9, 2023
First Submitted That Met QC Criteria
November 9, 2023
First Posted (Actual)
November 15, 2023
Study Record Updates
Last Update Posted (Estimated)
December 7, 2023
Last Update Submitted That Met QC Criteria
November 30, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34DA048065 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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