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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06132282
Other study ID # R34DA048065
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 21, 2022
Est. completion date July 27, 2023

Study information

Verified date November 2023
Source Texas Christian University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 27, 2023
Est. primary completion date July 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Texas Christian University Fort Worth Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas Christian University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary problem recognition 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
Primary decision making 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
Primary intention to reduce personal risk 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
Primary service initiation 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). Baseline, Week 7, Week 15
Primary substance use 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
Primary sexual/STI health risk 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
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