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Engaging Family Members During Early SUD Treatment: A Hybrid Trial

11 maj 2026 uppdaterad av: Karen Osilla, Stanford University

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Kirsten Becker, MPH
  • Telefonnummer: (866) 697-5620
  • E-post: becker@rand.org

Studieorter

    • California
      • San Diego, California, Förenta staterna, 92012
        • Family Health Centers of San Diego
        • Kontakt:
          • Joe Sepulveda, MD
          • Telefonnummer: (619) 515-2300
          • E-post: joes@fhcsd.org

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Faktoriell uppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / 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-jämförare: Aim 2: Arm 16
No Strategies
No engagement strategies

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Attendance
Tidsram: 2 months after baseline
Attend at least 1 eINSPIRE session
2 months after baseline

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility of Engagement Strategies
Tidsram: 6 months from enrollment
Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility
6 months from enrollment
Acceptability of Engagement Strategies
Tidsram: 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
Tidsram: 6 months from enrollment
Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness
6 months from enrollment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 juli 2026

Primärt slutförande (Beräknad)

31 januari 2027

Avslutad studie (Beräknad)

31 mars 2027

Studieregistreringsdatum

Först inskickad

6 maj 2026

Först inskickad som uppfyllde QC-kriterierna

6 maj 2026

Första postat (Faktisk)

12 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Aggregate quantitative survey data from Aim 2 will still be provided. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier (GUID) for the NIMH Data Archive (NDA) will be collected for each subject. Participant-level data, survey instruments, and measurement descriptions will be deposited to NIMH Data Archive in accordance with the NIH Data Management and Sharing Policy effective January 24, 2023.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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