NCT04678960

Brief Summary

Across the US, substance use is a significant public health concern, with juvenile justice (JJ)-involved youth representing a particularly vulnerable population. The current study proposes to adapt and test an intervention Trust-based Relational Intervention® (TBRI®) for preventing initiation and/or escalation of opioid misuse among older adolescents involved in the JJ system. Successful completion of study aims will provide information on TBRI's utility for older JJ adolescents, barriers and facilitators of sustainment, and provide training and implementation support for sustainment in participating facilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

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

First Submitted

Initial submission to the registry

November 11, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

4.6 years

First QC Date

November 11, 2020

Last Update Submit

December 10, 2025

Conditions

Keywords

trauma-informed carejustice-involved youthprevention for opioid use and other substancesTrust-based relational intervention (TBRI)youth-caregiver relationship

Outcome Measures

Primary Outcomes (3)

  • Youth days to opioid (and other substance use) initiation

    Initiation to opioid and other substance use (e.g., alcohol, marijuana, methamphetamine) over 15 months follow-up in days, measured by the scale of Timeline follow-back, Substance Use Involvement (i.e., during the past 30 days, how many days did you use alcohol or drugs; developed by the HEAL Prevention Cooperative), urinalysis results. Scores: 0-450 days; a higher score indicating a better outcome.

    15 months

  • Youth months to opioid (and other substance use) initiation

    Initiation to opioid and other substance use over 15 months follow-up in months, monthly check-ins (any opioid use; any alcohol, other drug use in the past month). Scores: 0-15 months; a higher score indicating a better outcome.

    15 months

  • Youth substance use severity

    Opioid use and other substance use (e.g., alcohol, marijuana, methamphetamine) over 15 months; measured by TCU Drug Screen 5 and TCU Drug Screen 5 - Opioid Supplement. Scores: 0-11, a higher score indicating a worse outcome.

    15 months

Secondary Outcomes (15)

  • Self-regulation (youth) - positive and negative urgency

    15 months

  • Self-regulation (youth) - delayed discounting

    15 months

  • Self-regulation (youth) - emotion regulation

    15 months

  • Self-regulation (youth) - executive functioning

    15 months

  • Self-efficacy (youth)

    15 months

  • +10 more secondary outcomes

Other Outcomes (7)

  • Frequency of receiving substance use treatment

    15 months

  • Times of hospital visits related to substance use

    15 months

  • Times of treatment referral for substance use

    15 months

  • +4 more other outcomes

Study Arms (4)

Standard Reentry Practice

NO INTERVENTION

Youth/safe adult participants only receive assessments (baseline assessment while youth are at the facility; 3, 6, 12, 18 months follow-up assessments after youth are released from the facility).

TBRI Training only

EXPERIMENTAL

Youth/safe adult dyads participate in 9 TBRI caregiver modules (caregivers only), 9 youth modules (youth only), and 4 Nurture Groups (caregiver and youth joint role-play activities) prior to youth's release. After the youth's release, they would receive phone support (only when requested by the caregiver or youth).

Behavioral: Trust-based Relational Intervention Training

TBRI Training + TBRI In-Home Structured Coaching

EXPERIMENTAL

Youth/safe adult dyads participate in 9 TBRI caregiver modules (caregivers only), 9 youth modules (youth only), and 4 Nurture Groups (caregiver and youth joint role-play activities) prior to youth's release. After youth's release, trained TCU TBRI Practitioners provide coaching sessions to youth/safe adult dyads in which they meet 4 times (once monthly) over the first 4 months following release.

Behavioral: Trust-based Relational Intervention TrainingBehavioral: Trust-based Relational Intervention In-Home Structured Coaching

TBRI Training + TBRI In-Home Responsive Coaching

EXPERIMENTAL

Youth/safe adult dyads participate in 9 TBRI caregiver modules (caregivers only), 9 youth modules (youth only), and 4 Nurture Groups (caregiver and youth joint role-play activities) prior to youth's release. After youth's release, trained TCU TBRI Practitioners provide coaching sessions to youth/safe adult dyads. They meet a minimum of 2 times during the first 2 months after release. Starting from Month 3, TBRI Practitioners would provide additional coaching when requested or when a research assistant (RA) identifies a need for additional coaching sessions.

Behavioral: Trust-based Relational Intervention TrainingBehavioral: Trust-based Relational Intervention In-Home Responsive Coaching

Interventions

The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching. TBRI Group Training is comprised of three components: TBRI Youth Group Training (youth only), Caregiver Training (caregivers only), and Nurture Groups (youth-caregiver joint roleplay activities), which is conducted prior to youth's release.

Also known as: TBRI
TBRI Training + TBRI In-Home Responsive CoachingTBRI Training + TBRI In-Home Structured CoachingTBRI Training only

The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching. TBRI In-Home Structured Training includes four structured in-home coaching sessions.

Also known as: TBRI Structured Coaching
TBRI Training + TBRI In-Home Structured Coaching

The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching. TBRI In-Home Responsive Training includes at least 2 structured in-home coaching sessions plus additional sessions indefinitely as needed.

Also known as: TBRI Responsive Coaching
TBRI Training + TBRI In-Home Responsive Coaching

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • For the effectiveness component,
  • Youth ages 15-18 at study enrollment
  • Being disposed to community supervision (i.e., probation) following a minimum of 2 months in the secure residential JJ facility
  • No indication of active suicide risk
  • Being able to identify one safe adult that is willing to participate in the study.
  • For the implementation component:
  • All staff with direct care or supervisory responsibilities within and outside the facilities (i.e., officers supervising youth after release) working with TCU on the LeSA project.

You may not qualify if:

  • Youth outside the age range described above
  • Active suicide risk at the time of recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Illinois Youth Center - Chicago

Chicago, Illinois, 60612, United States

Location

Illinois Youth Center - Pere Marquette

Grafton, Illinois, 62037, United States

Location

Illinois Youth Center- Harrisburg

Harrisburg, Illinois, 62946, United States

Location

Illinois Youth Center- Warrenville

Naperville, Illinois, 60563, United States

Location

Illinois Youth Center - St. Charles

St. Charles, Illinois, 60175, United States

Location

Grayson County Juvenile Center/Boot Camp

Denison, Texas, 75020, United States

Location

Texas Monarch Academy for Girls/Rite of Passage

Denison, Texas, 75020, United States

Location

Williamson County Juvenile Services

Georgetown, Texas, 78626, United States

Location

Lake Granbury Youth Services/Rite of Passage

Granbury, Texas, 76048, United States

Location

Harris County Youth Village

Houston, Texas, 77586, United States

Location

Collin County Juvenile Probation Services

McKinney, Texas, 75071, United States

Location

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MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Danica K Knight, Ph.D.

    Texas Christian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: An effectiveness-Implementation Hybrid Design - Type 1; Randomized controlled trial and delayed-start study testing the effectiveness of Trust-based Relational Intervention and three different support formats (no coaching/structured coaching/adaptive coaching) among Juvenile Justice (JJ)-involved youth transitioning to their communities and a safe adult (e.g. parent/guardian, extended family member). In the delayed-start design, JJ agencies are randomly assigned to four different starting points with two months apart for starting the project. The last 18-months of the delayed-start design will provide a naturalistic investigation of sustainment of the intervention within the facilities after responsibility for intervention delivery has been transferred from TCU to the JJ agencies (TCU provide trainings to foster in-house TBRI expertise and assistance for implementation).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2020

First Posted

December 22, 2020

Study Start

February 15, 2021

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All data will be further de-identified (e.g., by systematically scrambling Study IDs within study sites) before being shared with the HEAL Prevention Coordinating Center. The Coordinating Center will not have access to identifying information, nor will they have access to or knowledge of how participant study identification numbers were scrambled. The data will also be shared publicly, following the HEAL Prevention Guidance for Appropriate Public Access and Data Sharing Plans, including the following aspects: * Electronic copies of publications will be deposited within 4 weeks of acceptance * Publications will be published under the Creative Commons Generic License * Publications will be made publicly available immediately without embargo * Underlying Primary Data for the Publications will be made broadly available * Sharing of Underlying Primary Data must be responsive to protecting confidential and proprietary data and is consistent with applicable laws and regulations.

Time Frame
The data will be shared with the HEAL Prevention Cooperative between 2021 and 2024. Sharing of underlying primary data for the publications will be made broadly available through an appropriate data repository, such as the NIH HEAL Initiative central data repository, or a non-NIH repository that conforms to the principles articulated in the HEAL Public Access and Data Sharing Policy (referred to in the URL included below).
Access Criteria
All research teams that participate in the NIH Helping to End Addiction Long-term (HEAL) Initiative. https://heal.nih.gov/files/2020-01/2020-01-16\ data-sharing-4.pdf
More information

Locations