- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05619185
Eine SMART-Bewertung einer adaptiven webbasierten AUD-Behandlung für Servicemitglieder und ihre Partner
The purpose of this study is to evaluate the efficacy of an adaptive web intervention (Partners Connect) on military spouse drinking behaviors (CPs) and service member help-seeking (SMs). The investigators want to identify for whom this intervention is most efficacious and on what drinking behaviors and mechanisms. The investigators hypothesize that the intervention will reduce concerned partner drinking and increase service member help-seeking, compared to website resources, and that phone-based CRAFT will increase help-seeking behaviors, compared to those who are guided via a CRAFT workbook.
Our outcome is to evaluate the efficacy of an adaptive CP intervention on CP well-being and service member help-seeking.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Kat Nameth, BS
- Telefonnummer: 6505429699
- E-Mail: knameth@stanford.edu
Studienorte
-
-
California
-
Palo Alto, California, Vereinigte Staaten, 94305
- Rekrutierung
- Stanford University
-
Kontakt:
- Kat Nameth, BS
- Telefonnummer: 6505429699
- E-Mail: knameth@stanford.edu
-
Hauptermittler:
- Karen Osilla, PhD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- at least 18 years of age;
- be living together with their partner, with no plans to change that status in the next 2 months;
- not be in the military themselves (to reduce concerns about mandated reporting of alcohol use);
- score ≥4 on the AUDIT-C for females or ≥5 for males/other;
- respond yes to "Do you feel safe in your current relationship?" from the Partner Violence Screen;
- report not currently being in mental health or alcohol treatment (CP and SM)
- understand English fluently,
- be willing to try an online program to address risky drinking.
We require cohabitating CPs and SMs with no anticipated changes in the next two months to ensure close contact and opportunity to practice new skills, and those who would feel safe participating.
Exclusion Criteria:
- CPs in substance use treatment or their SM was in treatment in the last three months;
- does not feel safe in the current relationship;
- does not understand English fluently;
- has an impaired capacity (cognitive, visual, or hearing);
- is not cohabitating with their SM
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Intervention
Those randomized to the CRAFT intervention will receive a web-based intervention |
Session 1 addresses CPs' mental health issues and drinking. CPs select reasons why they are seeking help and steps they will take towards those goals. Session 2 is focused on improving their relationship through communication exercises. Session 3 is focused on functional analysis of their partner's drinking, and how to positively reinforce their partner's sobriety and negatively reinforce their drinking. Finally, Session 4 focuses on continuing self-care and talking with their partner about their concerns while interacting with them in healthy ways. The WBI contains audio, video, text, and exercises that utilize digital storytelling and vignettes to convey teaching points - a method utilized by the military to address stigma and increase treatment utilization. Actresses portrayed different experiences that the CP may be going through and modeled skills. CPs clicked on the vignette that they most connected with and followed that character across all the sessions.
Andere Namen:
The phone-based CRAFT intervention consists of six individual sessions with a CRAFT clinician that will explore what they learned from the WBI and additional skills they need. Session content includes positive reinforcement of non-drinking SM behaviors, refraining from interfering in SM's consequences of alcohol use, communication skills, and self-care.
Andere Namen:
The self-directed CRAFT workbook Table 1.Partners Connect WBI has a parent and partner version that uses CRAFT to help the CP help with understanding, self-care, communication, and actions (e.g., how to react when a partner has been using substances and when they have not been using substances, how to talk to partner so that they are more likely to be heard) and includes more information about communicating than the WBI and several interactive worksheets.
Andere Namen:
|
|
Aktiver Komparator: Control
Those randomized to CONTROL will complete a self-guided intervention |
To match time spent reviewing the website, CPs will receive an orientation guide that includes the website URL and a 4-week guide for how they can navigate this website for 20-30 minutes per week (e.g., read article "'It's Not My Fault!': Why Defensiveness is Damaging" and write down one tool to dissolve defensiveness you're willing to try). We will send reminder emails each week to visit the website and include questions in the emails and our first online follow-up survey asking CPs approximately how many times they visited the website and how long they spent viewing content on the website. Reminder emails will be programmed such that CPs get directed automatically to the website if the CP notes no time spent on it. |
|
Experimental: Phone Based CRAFT
If a member of the recruited dyad does not respond, then participants will be randomized to receive phone-based CRAFT |
Session 1 addresses CPs' mental health issues and drinking. CPs select reasons why they are seeking help and steps they will take towards those goals. Session 2 is focused on improving their relationship through communication exercises. Session 3 is focused on functional analysis of their partner's drinking, and how to positively reinforce their partner's sobriety and negatively reinforce their drinking. Finally, Session 4 focuses on continuing self-care and talking with their partner about their concerns while interacting with them in healthy ways. The WBI contains audio, video, text, and exercises that utilize digital storytelling and vignettes to convey teaching points - a method utilized by the military to address stigma and increase treatment utilization. Actresses portrayed different experiences that the CP may be going through and modeled skills. CPs clicked on the vignette that they most connected with and followed that character across all the sessions.
Andere Namen:
The phone-based CRAFT intervention consists of six individual sessions with a CRAFT clinician that will explore what they learned from the WBI and additional skills they need. Session content includes positive reinforcement of non-drinking SM behaviors, refraining from interfering in SM's consequences of alcohol use, communication skills, and self-care.
Andere Namen:
|
|
Aktiver Komparator: CRAFT Workbook
If a member of the recruited dyad does not respond, then participants will be randomized to receive a CRAFT workbook |
Session 1 addresses CPs' mental health issues and drinking. CPs select reasons why they are seeking help and steps they will take towards those goals. Session 2 is focused on improving their relationship through communication exercises. Session 3 is focused on functional analysis of their partner's drinking, and how to positively reinforce their partner's sobriety and negatively reinforce their drinking. Finally, Session 4 focuses on continuing self-care and talking with their partner about their concerns while interacting with them in healthy ways. The WBI contains audio, video, text, and exercises that utilize digital storytelling and vignettes to convey teaching points - a method utilized by the military to address stigma and increase treatment utilization. Actresses portrayed different experiences that the CP may be going through and modeled skills. CPs clicked on the vignette that they most connected with and followed that character across all the sessions.
Andere Namen:
The self-directed CRAFT workbook Table 1.Partners Connect WBI has a parent and partner version that uses CRAFT to help the CP help with understanding, self-care, communication, and actions (e.g., how to react when a partner has been using substances and when they have not been using substances, how to talk to partner so that they are more likely to be heard) and includes more information about communicating than the WBI and several interactive worksheets.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
CP Depression
Zeitfenster: Baseline to 6 month follow-up
|
Depression as measured by the global score on the Patient Health Questionnaire 9-item (PHQ-9). Scores range from 0 - 27. Higher scores indicate more severe depression. |
Baseline to 6 month follow-up
|
|
CP Anxiety
Zeitfenster: Baseline to 6 month follow-up
|
Anxiety as measured by the global score on the Generalized Anxiety Disorder 7-item scale (GAD-7). Scores range from 0 - 21. Higher scores indicate more severe anxiety. |
Baseline to 6 month follow-up
|
|
Service Member help-seeking
Zeitfenster: Baseline to 6 month
|
Completion of the personalized normalized feedback (PNF) component of the intervention as a signal of increase help-seeking behavior |
Baseline to 6 month
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
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
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 67087
- 1R01AA030258 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
There will be no IPD shared
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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