CClinicalTrials.gg
CompletedNCT06132282SUHRIUpdated Jan 29, 2025Results posted

The Substance Use and Health Risk Intervention (SUHRI) for Justice-involved Youth

An interventional study of Substance Use and Health Risk Intervention (SUHRI) in Substance Use Disorders, sponsored by Texas Christian University. Completed at 1 site in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by Texas Christian University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jun 2022, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
14 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Substance Use Disorders
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 40 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Texas Christian University is the lead sponsor of 33 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • no indication of suicide risk or thought disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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. 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

  • BehavioralSubstance 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.

06

What researchers measure

Primary outcomes

  1. Service Initiation

    Number of Participants Who Initiated Substance Use or Health Services; obtained through client interviews.

    Time frame: Baseline

  2. Service Initiation

    Number of Participants Who Initiated Substance Use or Health Services; obtained through client interviews.

    Time frame: Week 7

07

Results

Posted Jan 29, 2025

Participant flow

Participant flow — Overall Study
MilestoneSubstance Use and Health Risk Intervention (SUHRI)
Started40
Completed9
Not completed31
Withdrew: Lost to follow-up31

Outcome measures

PrimaryService Initiation

Number of Participants Who Initiated Substance Use or Health Services; obtained through client interviews.

Time frame:
Baseline
Reported as:
Count of participants · Participants
Service Initiation
ParticipantsSubstance Use and Health Risk Intervention (SUHRI)
Service Initiation15
PrimaryService Initiation

Number of Participants Who Initiated Substance Use or Health Services; obtained through client interviews.

Time frame:
Week 7
Reported as:
Count of participants · Participants
Service Initiation
ParticipantsSubstance Use and Health Risk Intervention (SUHRI)
Service Initiation4

Adverse events

Collected over 15 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Substance Use and Health Risk Intervention (SUHRI)0/40 (0%)7/40 (17.5%)0/40 (0%)
Most frequent serious events
Most frequent serious events
EventSubstance Use and Health Risk Intervention (SUHRI)
detentionSocial circumstances4/40
hospitalizationGeneral disorders3/40

Baseline characteristics

Age, Continuous
Age, Continuous(years)Substance Use and Health Risk Intervention (SUHRI)
Mean15.76 (14 to 18)
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Substance Use and Health Risk Intervention (SUHRI)
FEMALE8
MALE27
UNKNOWN5
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Substance Use and Health Risk Intervention (SUHRI)
Hispanic or Latino11
Not Hispanic or Latino23
Unknown or Not Reported6
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Substance Use and Health Risk Intervention (SUHRI)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American17
White10
More than one race3
Unknown or Not Reported10
Region of Enrollment
Region of Enrollment(participants)Substance Use and Health Risk Intervention (SUHRI)
United States40
08

Study locations

1 site
  • Texas Christian University
    Fort Worth, Texas 76109, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 8, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06132282
Lead sponsor
Texas Christian University
Responsible party
DanicaKnight (Professor, Texas Christian University) — Principal investigator
First posted
Nov 15, 2023
Start date
Jun 21, 2022
Primary completion
Jul 27, 2023
Completion
Jul 27, 2023
Results posted
Jan 29, 2025
Last update
Jan 29, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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