- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility of STAR Intervention in Dyads
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 111148
- R61DA064790 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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