Engaging Family Members During Early SUD Treatment: A Hybrid Trial
The goal of this study is a fractional factorial optimization trial to optimize engagement in a CRAFT program for family members with loved ones in outpatient treatment for a substance use disorder.
This study aims to identify family engagement strategies that are feasible, acceptable, and appropriate and effective in increasing family member initiation with CRAFT. Participants will complete an iterative, online process where they will evaluate and rank different engagement strategies to identify the most optimal in increasing engagement and then participate in an optimization trial to identify which strategies were most effective in increasing family member engagement.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Family members (FMs) of people with substance use disorder (SUD)-including biological, extended, or chosen family-face chronic stress and are at high risk for mental and physical health problems. The impact is worsened by stigma, guilt, shame, and self-blame that often accompany a loved one's substance use, leading to social isolation and uncertainty about how to support recovery. Although FMs are motivated to help with treatment navigation, many do not seek support for themselves. Programs like Community Reinforcement and Family Training (CRAFT) can support FMs and provide tools to improve their own lives while assisting their loved one's recovery. While CRAFT is well-established in community settings for increasing a family member's initiation into treatment, its applicability in clinical SUD settings is less clear. It remains unknown whether CRAFT can enhance patient treatment retention in clinical settings and whether FMs who might not seek care would participate.
To advance the science of engaging and supporting families impacted by SUD, investigators will (1) Conduct an iterative online process with FMs and clinic staff to identify potential family engagement strategies that community health centers (CHCs) can deliver that are effective, feasible, acceptable, and appropriate, and (2) Test those strategies using a fractional factorial trial.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Kat Nameth, MS
- Telefonnummer: 650-542-9699
- E-mail: knameth@stanford.edu
Undersøgelse Kontakt Backup
- Navn: Kirsten Becker, MPH
- Telefonnummer: (866) 697-5620
- E-mail: becker@rand.org
Studiesteder
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-
California
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San Diego, California, Forenede Stater, 92012
- Family Health Centers of San Diego
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Kontakt:
- Joe Sepulveda, MD
- Telefonnummer: (619) 515-2300
- E-mail: joes@fhcsd.org
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
FAMILY MEMBERS:
Inclusion Criteria:
- 18 years old or older
- A parent, child, sibling, spouse/romantic partner, or other adult supporting a loved one who initiated SUD treatment in past 3 months
- Cohabitating with their loved one
- In frequent contact (in-person or virtual) with their loved one (at least 3x/week)
- Not worried about potential physical harm from their loved one
- Report no illicit drug use in the past year
PATIENTS:
Inclusion Criteria:
- 18 years old or older
- In frequent contact with a family member (at least 3x/week) that they cohabitate with
- Have initiated substance use treatment in past 3 months
CLINIC PROVIDERS:
Inclusion Criteria:
- Counselor/Clinician providing care at our partner clinic for SUD
Exclusion Criteria (ALL):
- Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)
- Does not understand English fluently
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Aim 2: Arm 1
All 4 Engagement Strategies
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 2
Strategies 1-3
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 3
Strategies 1-2
|
Engagement Strategy
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 4
Strategies 2-4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 5
Strategies 3-4
|
Engagement Strategy
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 6
Strategies 1 & 3
|
Engagement Strategy
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 7
Strategies 2 & 4
|
Engagement Strategy
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 8
Strategies 1, 2 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 9
Strategies 2-3
|
Engagement Strategy
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 10
Strategies 1, 3 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 11
Strategy 1
|
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 12
Strategy 2
|
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 13
Strategy 3
|
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 14
Strategy 4
|
Engagement Strategy
|
|
Aktiv komparator: Aim 2: Arm 15
Strategy 1 & 4
|
Engagement Strategy
Engagement Strategy
|
|
Placebo komparator: Aim 2: Arm 16
No Strategies
|
No engagement strategies
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Attendance
Tidsramme: 2 months after baseline
|
Attend at least 1 eINSPIRE session
|
2 months after baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of Engagement Strategies
Tidsramme: 6 months from enrollment
|
Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility
|
6 months from enrollment
|
|
Acceptability of Engagement Strategies
Tidsramme: 6 months from enrollment
|
Assessed via the Acceptability of Intervention Measure; 70%+ agree/strongly agree indicates acceptability
|
6 months from enrollment
|
|
Appropriateness of Engagement Strategies
Tidsramme: 6 months from enrollment
|
Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness
|
6 months from enrollment
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Karen Osilla, PhD, Stanford University
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
- IRB-86357
- 1R61DA064789-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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-
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-
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