NCT07596251

Brief Summary

The goal of this clinical trial is to determine whether a new, paired coaching intervention improves outcomes for individuals with criminal legal system involvement recovering from substance use disorder, as well as the loved ones of those individuals. The initial phase (Year 1) includes a small preliminary pilot examining the feasibility of the intervention. During the full clinical trial (Years 2-5), this study aims to answer whether this approach...

  • ...improves the recovering person's recovery capital?
  • ...improves well-being, as well as resource knowledge and awareness, for the loved one?
  • ...improves social support and connection among both individuals? Participants will:
  • Meet regularly one-on-one with their individual coaches (a Recovery Coach for the recovering person; a Loved One Coach for the loved one) during the 6 week intervention period
  • Meet regularly as a group of four (both coaches and both participants) during this same period
  • Complete follow-up interviews with research staff at 6- and 12-weeks after beginning the study

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
55mo left

Started Sep 2026

Longer than P75 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

4.5 years

First QC Date

May 13, 2026

Last Update Submit

May 22, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • Feasibility of STAR Intervention in Dyads

    a. Feasibility will be assessed using the STAR Project Focus Group Survey questions administered to dyad participants following intervention sessions. A higher score indicates greater perceived feasibility.

    Immediately following intervention sessions during 6-week feasibility pilot.

  • Acceptability of STAR Intervention in Dyads

    a. Acceptability will be assessed using the Focus Group Survey questions administered to dyad participants following intervention sessions. A higher score indicates greater perceived acceptability.

    Immediately following intervention sessions during 6-week feasibility pilot.

  • Recovery capital

    a. For recovering persons: The internal and external resources that impact an individual's capacity to initiate and sustain recovery, including physical, cultural, human, and social resources. Assessed using the Multidimensional Inventory of Recovery Capital (MIRC) a 28-item questionnaire. Higher scores indicate greater recovery capital.

    Assessed at enrollment and 6- and 12-weeks post-enrollment

  • Psychological well-being

    a. For loved ones: Positive affect, life satisfaction, and an overall sense of purpose and meaning. Assessed using the Neuro-QOL Positive Affect and Well-Being Scale, a 23-item questionnaire, Higher scores indicate greater psychological well-being.

    Assessed at enrollment and 6- and 12-weeks post-enrollment

  • SUD and CLS knowledge and resource awareness

    a. For loved ones: Knowledge regarding Substance Use Disorder (SUD) including recovery, treatment, harm reduction, and Criminal Legal System (CLS) involvement as well as awareness of local recovery and resources. Assessed using study developed knowledge assessment questions and count of local resources known. Higher scores indicate greater knowledge and resource awareness.

    Assessed at enrollment and 6- and 12-weeks post-enrollment

  • Support functions

    a. For loved ones and recovering persons: Number and types of support functions provided by social network members. Assessed using egocentric social network inventory questionnaire evaluating functional support provided by network members. Higher scores indicate greater perceived social support.

    Assessed at enrollment and 6- and 12-weeks post-enrollment

  • Social connection

    a. For loved ones and recovering persons: Level of trust, emotional closeness, and frequency of contact with social network members. Assessed using egocentric social network inventory questionnaire. Higher scores indicate stronger social connection and network engagement.

    Assessed at enrollment and 6- and 12-weeks post-enrollment

Study Arms (1)

STAR Intervention

EXPERIMENTAL
Behavioral: STAR Intervention

Interventions

The STAR intervention is a dyadic coaching model designed to support individuals with substance use disorder and criminal legal system involvement alongside their identified loved ones.

STAR Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recovering Persons:
  • At least 18 years old
  • Must have been involved with the criminal legal system (arrested, incarcerated, or on community supervision like parole or probation) within the past 12 months
  • Substance use disorder within the past 12 months
  • Interested in working with a recovery coach to support your recovery (defined as engaging in any changes to improve your health and wellness)
  • Can identify at least one person who is supportive of their recovery.
  • Loved Ones:
  • At least 18 years old
  • Interested in receiving additional supports and/or information about their loved one's substance use and criminal legal system involvement
  • Anticipate being available for weekly participation in intervention activities
  • Willing to support their loved one's recovery

You may not qualify if:

  • Loved ones:
  • Already have a professional relationship with the recovering person (e.g., as a counselor, sponsor, or peer recovery support specialist)
  • Meet substance use disorder criteria for any past 30-day drug or alcohol use
  • Have a history of domestic violence or protective orders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Design

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

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 19, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Last Updated

May 28, 2026

Record last verified: 2026-05