NCT06132282

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 29, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

November 9, 2023

Results QC Date

December 2, 2024

Last Update Submit

January 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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.

Behavioral: Substance Use and Health Risk Intervention (SUHRI)

Interventions

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.

Substance Use and Health Risk Intervention (SUHRI)

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • on community supervision (e.g., deferred adjudication or probation), 1+ indicator of SU, English-speaking,

You may not qualify if:

  • no indication of suicide risk or thought disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76109, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Danica Knight
Organization
Texas Christian University

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 15, 2023

Study Start

June 21, 2022

Primary Completion

July 27, 2023

Study Completion

July 27, 2023

Last Updated

January 29, 2025

Results First Posted

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations