AddictionNCT07596251
Support Towards Addiction Recovery for Individuals With Criminal Legal System Involvement: The STAR Project
A study testing STAR Intervention in people with Addiction, run by Martha Tillson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Addiction
- What is being tested?
- STAR Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 1 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Martha Tillson, (859) 323-5771, martha.tillson@uky.edu
About this study
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...
Read more
- ...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
- Conditions
- Addiction
- Being tested
- STAR Intervention
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| STAR Intervention | Experimental | Not described Receives: Behavioral: STAR Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of STAR Intervention in Dyads
- 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.
Measured: Immediately following intervention sessions during 6-week feasibility pilot.
Acceptability of STAR Intervention in Dyads
- Acceptability will be assessed using the Focus Group Survey questions administered to dyad participants following intervention sessions. A higher score indicates greater perceived acceptability.
Measured: Immediately following intervention sessions during 6-week feasibility pilot.
Recovery capital
- 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.
Measured: Assessed at enrollment and 6- and 12-weeks post-enrollment
Psychological well-being
- 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.
Measured: Assessed at enrollment and 6- and 12-weeks post-enrollment
SUD and CLS knowledge and resource awareness
- 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.
Measured: Assessed at enrollment and 6- and 12-weeks post-enrollment
Support functions
- 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.
Measured: Assessed at enrollment and 6- and 12-weeks post-enrollment
Social connection
- 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.
Measured: Assessed at enrollment and 6- and 12-weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start15 Oct 2026
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martha Tillson
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Martha Tillson, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596251
- Sponsor's protocol ID
- 111148
- Other IDs
- R61DA064790
- Status last verified
- Oct 2026
- First submitted
- 13 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Towards Addiction Recovery for Individuals With Criminal Legal System Involvement: The STAR Project
- ClinicalTrials.gov ID
- NCT07596251
- Acronym / sponsor ID
- 111148
- Conditions
- Addiction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Martha TillsonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STAR Intervention | Experimental | Behavioral: STAR Intervention |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR InterventionThe 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. | Behavioural | STAR Intervention |
Primary outcome
Feasibility of STAR Intervention in Dyads
Time frame: Immediately following intervention sessions during 6-week feasibility pilot.
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.
Acceptability of STAR Intervention in Dyads
Time frame: Immediately following intervention sessions during 6-week feasibility pilot.
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.
Recovery capital
Time frame: Assessed at enrollment and 6- and 12-weeks post-enrollment
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.
Psychological well-being
Time frame: Assessed at enrollment and 6- and 12-weeks post-enrollment
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.
SUD and CLS knowledge and resource awareness
Time frame: Assessed at enrollment and 6- and 12-weeks post-enrollment
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.
Support functions
Time frame: Assessed at enrollment and 6- and 12-weeks post-enrollment
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.
Social connection
Time frame: Assessed at enrollment and 6- and 12-weeks post-enrollment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR Intervention in people with Addiction, run by Martha Tillson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha Tillson ((859) 323-5771, martha.tillson@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of STAR Intervention in Dyads (time frame: Immediately following intervention sessions during 6-week feasibility pilot.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.