NCT Number: NCT05991882
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.
Interested in participating?
Request Info18 year–30 year
All sexes
Interventional
Not applicable
Honolulu, Hawaii, 96815, United States
Location status: Recruiting
Kara Tsuzaki, PharmD
CONTACT
Kristina Phillips, PhD
CONTACT
Kristina Phillips, PhD
PRINCIPAL_INVESTIGATOR
Up to one-third of young adults report use of marijuana or alcohol in the past month, with sizable numbers reporting daily marijuana use and heavy episodic drinking. Simultaneous alcohol and marijuana (SAM) use, defined as use of both substances at the same time or within a few hours of each other with overlapping effects, is common among young adults. Recent research has shown that SAM use leads to greater negative consequences compared to use of either substance alone. No current intervention addresses SAM use specifically and few leverage new technological methods (e.g., smartphones) or strategies (e.g., protective behavioral strategies [PBS]) to engage young adults.
The goal of this Stage I treatment development project is to develop a fully mobile adaptive ecological momentary intervention (a-EMI) titled "Smartphone App For Effectively Reducing Risk (SAFERR)" 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. They will assess the feasibility and efficacy of intervention components on two outcomes (negative consequences and PBS) using a fractional factorial experimental design.
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, the SAFERR a-EMI will be administered to 6 eligible participants. Based on the feedback, the app will be revised and a trial of the SAFERR intervention will begin. 136 diverse young adults who report current SAM use will be recruited from primary care clinics at KPHI. Eligible individuals will complete a baseline assessment and then be randomly assigned (by sex) to one of eight conditions using stratified randomization. Each condition either includes or does not include four different intervention strategies focused on craving reduction and PBS. All participants will complete signal-contingent (random prompts three times per day) and event-related ecological momentary assessment (EMA) for 6 weeks using a smartphone application (app). EMA will continue during the 4-week intervention phase. At the beginning of the intervention, all participants will complete an introduction module via the study app that includes psychoeducation, personalized feedback, and goal setting. Participants will then begin the a-EMI via the study app, with components delivered based on their condition assignment.
Following completion of the intervention, participants will complete a post-intervention assessment and follow-up assessments at one- and three-months. The feasibility of the a-EMI and design will be examined by assessing: study attrition and response rates/time, module completion rates, acceptability (satisfaction, usability), perceived helpfulness, goal attainment, and implementation and intervention engagement. The efficacy of intervention components on negative consequences and PBS during EMA and at post-intervention and one-month and three-month follow-ups will be examined. In a future, larger study, the most useful components will be incorporated into a full intervention package and tested in a randomized controlled trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in this condition will complete ecological momentary assessment (EMA) for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily, until the end of the six-week period.
Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages delivered once daily and PBS trigger messages that will be based on responses to signal-contingent EMA questions.
Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages that will be delivered based on responses to signal-contingent EMA questions and PBS delivered once daily.
Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and PBS messages delivered based on responses to signal-contingent EMA questions.
Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive PBS messages delivered once daily and PBS trigger messages that will be based on responses to signal-contingent EMA questions.
Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages delivered once daily and craving reduction trigger messages that will be based on responses to signal-contingent EMA questions.
Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and PBS messages delivered once daily and non-repetitive craving reduction and PBS trigger messages that will be based on responses to signal-contingent EMA questions.
Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will not receive any further intervention strategies.
Time frame: Through study completion, an average of 5 months
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).
Time frame: Through study completion, an average of 5 months
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.
Time frame: Through study completion, an average of 5 months
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.
Time frame: Through study completion, an average of 5 months
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.
Time frame: Week 7
Number of completed prompts across 6-week EMA
Time frame: Week 7
Completion of introduction module focused on psychoeducation, personalized feedback, and goal setting
Time frame: Week 7
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).
Time frame: Week 7
A Feedback Measure will assess perceptions of the helpfulness of particular intervention strategies, as well as other useful strategies that could be added.
Time frame: Week 7
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.
Time frame: Week 7
Intervention engagement will be assessed by examining participant's use of intervention strategies.
Time frame: Through study completion, an average of 5 months
Participants will be asked to report whether they attained or made progress on goals identified in the a-EMI introduction module.
Contact information is provided by the study sponsor or research team.
Kaiser Permanente
Other
Mobile Adaptive Intervention to Reduce Negative Consequences Associated With Simultaneous Alcohol and Marijuana Use in Young Adults in Primary Care
Acronym: SAFERR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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