- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT05619185
SMART-arvio mukautuvasta verkkopohjaisesta AUD-hoidosta palvelun jäsenille ja heidän kumppaneilleen
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Kat Nameth, BS
- Puhelinnumero: 6505429699
- Sähköposti: knameth@stanford.edu
Opiskelupaikat
-
-
California
-
Palo Alto, California, Yhdysvallat, 94305
- Rekrytointi
- Stanford University
-
Ottaa yhteyttä:
- Kat Nameth, BS
- Puhelinnumero: 6505429699
- Sähköposti: knameth@stanford.edu
-
Päätutkija:
- Karen Osilla, PhD
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
|
|
Active Comparator: 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. |
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
|
|
Active Comparator: 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.
Muut nimet:
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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
CP Depression
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 67087
- 1R01AA030258 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
There will be no IPD shared
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .