Alcohol Drinking Clinical Trial
— SAFERROfficial title:
Mobile Adaptive Intervention to Reduce Negative Consequences Associated With Simultaneous Alcohol and Marijuana Use in Young Adults in Primary Care
The goal of this treatment development project is to develop an adaptive ecological momentary intervention (a-EMI) for young adults using marijuana and alcohol that is grounded in self-regulation and social cognitive theories. To determine the most efficacious intervention strategies, the investigators will test variations of intervention components to identify the best combination. The study will take place at the Center for Integrated Health Care Research at Kaiser Permanente Hawaii (KPHI), located in Honolulu (island of Oahu). Following pilot testing with 6 participants, the study team will assess the feasibility and efficacy of intervention components on two primary outcomes (negative consequences and protective behavioral strategies [PBS]) using a fractional factorial experimental design, with post-intervention assessment and one- and three-month follow-ups. 136 diverse young adults recruited from KPHI who report current simultaneous alcohol and marijuana (SAM) use will be randomly assigned to one of eight groups, representing experimental conditions that include or do not include intervention strategies focused on craving reduction and PBS. As a result of this process, individual and/or combined components that lead to improved outcomes will be retained in a subsequent randomized controlled trial, while ineffective components will be eliminated.
Status | Recruiting |
Enrollment | 136 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - resident of state of Hawai'i and island of O'ahu - age 18-30 years - has sought services at Kaiser Permanente Hawaii within the past year - report marijuana use, heavy drinking, and simultaneous alcohol and marijuana use - report confidence in ability to use protective behavioral strategies - endorse at least 3 recent negative consequences from marijuana and/or alcohol - own a smartphone Exclusion Criteria: • any substance use treatment within the past 3 months |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Hawaii, Center for Integrated Health Care Research | Honolulu | Hawaii |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Negative consequences associated with alcohol, marijuana, and simultaneous alcohol and marijuana (SAM) use | Changes in negative consequences will be assessed using a measure that assesses alcohol, marijuana, and SAM use negative consequences. Items are rated dichotomously (yes/no). | Through study completion, an average of 5 months | |
Primary | Protective behavioral strategies for alcohol | Changes in protective behavioral strategies for alcohol will be assessed using the Protective Drinking Practices Scale (PDPS), which assesses use of protective behavioral strategies related to alcohol on a 1 (never) to 6 (always) scale. | Through study completion, an average of 5 months | |
Primary | Protective behavioral strategies for marijuana | Changes in protective behavioral strategies for marijuana will be assessed using the Protective Behavioral Strategies for Marijuana (PBSM) Scale, which assesses use of protective behavioral strategies related to marijuana on a 1 (never) to 6 (always) scale. | Through study completion, an average of 5 months | |
Secondary | Feasibility - study attrition | Number of completed study phases, including six weeks of ecological momentary assessment (EMA), the 4-week a-EMI period, post-intervention assessment, and one- and three-month follow-up assessments. | Through study completion, an average of 5 months | |
Secondary | Feasibility - response rate | Number of completed prompts across 6-week EMA | Week 7 | |
Secondary | Feasibility - module completion rate | Completion of introduction module focused on psychoeducation, personalized feedback, and goal setting | Week 7 | |
Secondary | Feasibility - acceptability of the intervention | The revised Client Satisfaction Questionnaire (CSQ-8) will assess satisfaction with the intervention, perceptions of format and language of the a-EMI messages, and usability of the a-EMI (e.g., manner in which information was presented, language, question/intervention strategy comprehension, strategy delivery, timing, and study and a-EMI burden). | Week 7 | |
Secondary | Feasibility - perceived helpfulness of intervention strategies | A Feedback Measure will assess perceptions of the helpfulness of particular intervention strategies, as well as other useful strategies that could be added. | Week 7 | |
Secondary | Feasibility - intervention implementation | Intervention implementation will be examined through a short survey that will assess the ease of app use and accessibility, any challenges requesting strategies when needed, and any problems with the technology. | Week 7 | |
Secondary | Feasibility - intervention engagement | Intervention engagement will be assessed by examining participant's use of intervention strategies. | Week 7 | |
Secondary | Feasibility - goal attainment | Participants will be asked to report whether they attained or made progress on goals identified in the a-EMI introduction module. | Through study completion, an average of 5 months |
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