Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples

Официальное название

Developing and Testing an Online Intervention for Decreasing Alcohol and Cannabis Misuse and Increasing Healthy Relationship Skills Among Young Adult Couples: A Comprehensive Mixed-methods Approach

Обзор

The goal of this clinical trial is to develop and test a brief online intervention to reduce alcohol and cannabis misuse and improve healthy relationship skills among young adult couples. The main questions it aims to answer are: * Will the intervention be feasible and acceptable to young adult couples? * Will the intervention demonstrate initial efficacy in reducing risky substance use and increasing relationship functioning? Eligible couples will complete a virtual baseline session and be randomized to intervention condition (online intervention with 3-5 weeks of self-paced modules) or control condition (no intervention). Couples will complete two follow-up surveys (post-assessment - approximately 5 weeks after baseline, 3-month). Couples in the control condition will be offered the intervention after 3-month follow-up. Researchers will compare intervention and control groups to see if there there is a difference between the groups on substance misuse and relationship functioning at post-assessment and 3-month follow-up.

Вмешательства

• Поведенческое Online, couples-based intervention
  During Phase 1 of the present study, the intervention will be iteratively developed using a rigorous, user-centered design approach through integration of knowledge gained from Phase 1 dyadic analyses and qualitative interviews, and existing gold-standard treatments for substance use among couples, including Integrative Behavioral Couples Therapy (IBCT; Christensen \& Doss, 2016) and Behavioral Couples Therapy for Alcohol (ABCT; McCrady et al, 1995) and substance use brief interventions for youn

Первичные конечные точки

• Heavy episodic and high intensity drinking [Срок оценки: Screening, baseline, approximately 5 weeks after baseline, 3-month followup]
• Daily Drinking Questionnaire (DDQ) [Срок оценки: Screening, baseline, approximately 5 weeks after baseline, 3-month followup]
• Daily Marijuana Questionnaire (DMQ) [Срок оценки: Screening, baseline, approximately 5 weeks after baseline, 3-month followup]
• Intensity of Marijuana Use [Срок оценки: Screening, baseline, approximately 5 weeks after baseline, 3-month followup]
• Perceived Program Effects on Healthy Relationship Self-Efficacy items [Срок оценки: Screening, baseline, approximately 5 weeks after baseline, 3-month followup]
• Couples Satisfaction Index [Срок оценки: Screening, baseline, approximately 5 weeks after baseline, 3-month followup]

Критерии участия

Критерии включения

• Both partners in the couple are 18-29 years old
• In a committed romantic relationship (e.g., dating seriously, cohabiting, married) with each other for at least 3 months
• Face-to-face contact their partner at least 5 days per week
• Live in Washington State
• Have a valid email address and access to a cell phone
• Report alcohol and cannabis co-use at least three times in the past month
• Willingness to: complete online surveys during the allotted time frames, receive text messages and emails from the project, complete a baseline session, and participate during the same time period as their partner

Критерии исключения

• Couples who endorse any perpetration or receipt of severe interpersonal aggression during screening will be excluded and provided with resources

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Patrick ME. A Call for Research on High-Intensity Alcohol Use. Alcohol Clin Exp Res. 2016 Feb;40(2):256-9. doi: 10.1111/acer.12945. No abstract available. PMID 26842244
• Collins RL, Parks GA, Marlatt GA. Social determinants of alcohol consumption: the effects of social interaction and model status on the self-administration of alcohol. J Consult Clin Psychol. 1985 Apr;53(2):189-200. doi: 10.1037//0022-006x.53.2.189. No abstract available. PMID 3998247
• Lee CM, Kilmer JR, Neighbors C, Atkins DC, Zheng C, Walker DD, Larimer ME. Indicated prevention for college student marijuana use: a randomized controlled trial. J Consult Clin Psychol. 2013 Aug;81(4):702-9. doi: 10.1037/a0033285. Epub 2013 Jun 10. PMID 23750464
• Patrick ME, Veliz PT, Terry-McElrath YM. High-intensity and simultaneous alcohol and marijuana use among high school seniors in the United States. Subst Abus. 2017 Oct-Dec;38(4):498-503. doi: 10.1080/08897077.2017.1356421. Epub 2017 Jul 20. PMID 28726580
• Scott ME, Moore KA, Fish H, Benedetti A, Erikson S. OPRE Report #2015-65a. Prepared by Child Trends. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services. 2015. https://www.acf.hhs.gov/sites/default/files/documents/b_hmre_recommended_outcome_measures_for_adolescents_508_0.pdf
• Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572. PMID 18179329

Идентификаторы

NCT: NCT06422299 · STUDY00017992 · K23AA031034-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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