- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07596251
Support Towards Addiction Recovery for Individuals With Criminal Legal System Involvement: The STAR Project
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: STAR Intervention
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of STAR Intervention in Dyads
Tidsramme: 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.
|
Immediately following intervention sessions during 6-week feasibility pilot.
|
|
Acceptability of STAR Intervention in Dyads
Tidsramme: 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.
|
Immediately following intervention sessions during 6-week feasibility pilot.
|
|
Recovery capital
Tidsramme: 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.
|
Assessed at enrollment and 6- and 12-weeks post-enrollment
|
|
Psychological well-being
Tidsramme: 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.
|
Assessed at enrollment and 6- and 12-weeks post-enrollment
|
|
SUD and CLS knowledge and resource awareness
Tidsramme: 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.
|
Assessed at enrollment and 6- and 12-weeks post-enrollment
|
|
Support functions
Tidsramme: 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.
|
Assessed at enrollment and 6- and 12-weeks post-enrollment
|
|
Social connection
Tidsramme: 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.
|
Assessed at enrollment and 6- and 12-weeks post-enrollment
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 111148
- R61DA064790 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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-
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