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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 trial, testing the web-based intervention using a 1-arm design whereby 60 enrolled youth (who meet eligibility requirements) from one juvenile probation department are enrolled to participate. This clinical trial submission, and the accompanying IRB protocol are based on pilot 2 only.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substance Use and Health Risk Intervention (SUHRI) | Experimental | 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. This is the only arm for this clinical trial; and reflects pilot 2 only with accompanying IRB protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Substance Use and Health Risk Intervention (SUHRI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Service Initiation | Number of Participants Who Initiated Substance Use or Health Services; obtained through client interviews. | Baseline |
| Service Initiation | Number of Participants Who Initiated Substance Use or Health Services; obtained through client interviews. | Week 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Christian University | Fort Worth | Texas | 76109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Substance Use and Health Risk Intervention (SUHRI): 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. There is only one arm for this study, represented by pilot 2, and the accompanying IRB protocol |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Substance Use and Health Risk Intervention (SUHRI): 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Service Initiation | Number of Participants Who Initiated Substance Use or Health Services; obtained through client interviews. | Posted | Count of Participants | Participants | Baseline |
|
15 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Substance Use and Health Risk Intervention (SUHRI): 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danica Knight | Texas Christian University | 817-257-4391 | d.knight@tcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2023 | Jan 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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|
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Service Initiation | Number of Participants Who Initiated Substance Use or Health Services; obtained through client interviews. | those who completed the week 7 follow-up assessment | Posted | Count of Participants | Participants | Week 7 |
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| 0 |
| 40 |
| 7 |
| 40 |
| 0 |
| 40 |
| detention | Social circumstances | Non-systematic Assessment |
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