- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kat Nameth, MS
- Numéro de téléphone: 650-542-9699
- E-mail: knameth@stanford.edu
Sauvegarde des contacts de l'étude
- Nom: Kirsten Becker, MPH
- Numéro de téléphone: (866) 697-5620
- E-mail: becker@rand.org
Lieux d'étude
-
-
California
-
San Diego, California, États-Unis, 92012
- Family Health Centers of San Diego
-
Contact:
- Joe Sepulveda, MD
- Numéro de téléphone: (619) 515-2300
- E-mail: joes@fhcsd.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Aim 2: Arm 1
All 4 Engagement Strategies
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 2
Strategies 1-3
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 3
Strategies 1-2
|
Engagement Strategy
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 4
Strategies 2-4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 5
Strategies 3-4
|
Engagement Strategy
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 6
Strategies 1 & 3
|
Engagement Strategy
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 7
Strategies 2 & 4
|
Engagement Strategy
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 8
Strategies 1, 2 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 9
Strategies 2-3
|
Engagement Strategy
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 10
Strategies 1, 3 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 11
Strategy 1
|
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 12
Strategy 2
|
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 13
Strategy 3
|
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 14
Strategy 4
|
Engagement Strategy
|
|
Comparateur actif: Aim 2: Arm 15
Strategy 1 & 4
|
Engagement Strategy
Engagement Strategy
|
|
Comparateur placebo: Aim 2: Arm 16
No Strategies
|
No engagement strategies
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Attendance
Délai: 2 months after baseline
|
Attend at least 1 eINSPIRE session
|
2 months after baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of Engagement Strategies
Délai: 6 months from enrollment
|
Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility
|
6 months from enrollment
|
|
Acceptability of Engagement Strategies
Délai: 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
Délai: 6 months from enrollment
|
Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness
|
6 months from enrollment
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Karen Osilla, PhD, Stanford University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-86357
- 1R61DA064789-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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