- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07579299
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Kat Nameth, MS
- Telefoonnummer: 650-542-9699
- E-mail: knameth@stanford.edu
Studie Contact Back-up
- Naam: Kirsten Becker, MPH
- Telefoonnummer: (866) 697-5620
- E-mail: becker@rand.org
Studie Locaties
-
-
California
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San Diego, California, Verenigde Staten, 92012
- Family Health Centers of San Diego
-
Contact:
- Joe Sepulveda, MD
- Telefoonnummer: (619) 515-2300
- E-mail: joes@fhcsd.org
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Aim 2: Arm 1
All 4 Engagement Strategies
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 2
Strategies 1-3
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 3
Strategies 1-2
|
Engagement Strategy
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 4
Strategies 2-4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 5
Strategies 3-4
|
Engagement Strategy
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 6
Strategies 1 & 3
|
Engagement Strategy
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 7
Strategies 2 & 4
|
Engagement Strategy
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 8
Strategies 1, 2 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 9
Strategies 2-3
|
Engagement Strategy
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 10
Strategies 1, 3 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 11
Strategy 1
|
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 12
Strategy 2
|
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 13
Strategy 3
|
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 14
Strategy 4
|
Engagement Strategy
|
|
Actieve vergelijker: Aim 2: Arm 15
Strategy 1 & 4
|
Engagement Strategy
Engagement Strategy
|
|
Placebo-vergelijker: Aim 2: Arm 16
No Strategies
|
No engagement strategies
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Attendance
Tijdsspanne: 2 months after baseline
|
Attend at least 1 eINSPIRE session
|
2 months after baseline
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility of Engagement Strategies
Tijdsspanne: 6 months from enrollment
|
Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility
|
6 months from enrollment
|
|
Acceptability of Engagement Strategies
Tijdsspanne: 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
Tijdsspanne: 6 months from enrollment
|
Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness
|
6 months from enrollment
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Karen Osilla, PhD, Stanford University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB-86357
- 1R61DA064789-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
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