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Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults (SAFERR)

Primary Purpose

Alcohol Drinking, Cannabis Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Condition 1: Craving daily+PBS daily
Condition 2: Craving daily+PBS trigger
Condition 3: Craving trigger+PBS daily
Condition 4: Craving trigger+PBS trigger
Condition 5: PBS daily+ PBS trigger
Condition 6: Craving daily+Craving trigger
Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger
Condition 8: No daily or trigger craving or PBS
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Other

    Arm Label

    Condition 1: Craving daily+PBS daily

    Condition 2: Craving daily+PBS trigger

    Condition 3: Craving trigger+PBS daily

    Condition 4: Craving trigger+PBS trigger

    Condition 5: PBS daily+ PBS trigger

    Condition 6: Craving daily+Craving trigger

    Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger

    Condition 8: No daily or trigger craving or PBS

    Arm Description

    EMA + Introduction Module + Craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily

    EMA + Introduction Module + Craving reduction messages delivered once daily and PBS trigger messages

    EMA + Introduction Module + Craving reduction trigger messages and PBS messages delivered once daily

    EMA + Introduction Module + Craving reduction trigger and PBS trigger messages

    EMA + Introduction Module + PBS delivered once daily and PBS trigger messages

    EMA + Introduction Module + Craving reduction delivered once daily and craving reduction trigger messages

    EMA + Introduction Module + Craving reduction delivered once daily, craving reduction trigger messages, PBS delivered once daily, and PBS trigger messages

    EMA + Introduction Module + no other messages

    Outcomes

    Primary Outcome Measures

    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).
    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.
    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.

    Secondary Outcome Measures

    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.
    Feasibility - response rate
    Number of completed prompts across 6-week EMA
    Feasibility - module completion rate
    Completion of introduction module focused on psychoeducation, personalized feedback, and goal setting
    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).
    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.
    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.
    Feasibility - intervention engagement
    Intervention engagement will be assessed by examining participant's use of intervention strategies.
    Feasibility - goal attainment
    Participants will be asked to report whether they attained or made progress on goals identified in the a-EMI introduction module.

    Full Information

    First Posted
    May 1, 2023
    Last Updated
    August 7, 2023
    Sponsor
    Kaiser Permanente
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05991882
    Brief Title
    Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults
    Acronym
    SAFERR
    Official Title
    Mobile Adaptive Intervention to Reduce Negative Consequences Associated With Simultaneous Alcohol and Marijuana Use in Young Adults in Primary Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    January 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaiser Permanente
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking, Cannabis Use

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    Participants will be randomly assigned to one of eight conditions
    Masking
    Participant
    Masking Description
    Participants in the factorial trial will be informed generally of the assigned condition (i.e., introduction module + no daily messages or introduction module + daily messages), but not given detailed content.
    Allocation
    Randomized
    Enrollment
    136 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Condition 1: Craving daily+PBS daily
    Arm Type
    Experimental
    Arm Description
    EMA + Introduction Module + Craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily
    Arm Title
    Condition 2: Craving daily+PBS trigger
    Arm Type
    Experimental
    Arm Description
    EMA + Introduction Module + Craving reduction messages delivered once daily and PBS trigger messages
    Arm Title
    Condition 3: Craving trigger+PBS daily
    Arm Type
    Experimental
    Arm Description
    EMA + Introduction Module + Craving reduction trigger messages and PBS messages delivered once daily
    Arm Title
    Condition 4: Craving trigger+PBS trigger
    Arm Type
    Experimental
    Arm Description
    EMA + Introduction Module + Craving reduction trigger and PBS trigger messages
    Arm Title
    Condition 5: PBS daily+ PBS trigger
    Arm Type
    Experimental
    Arm Description
    EMA + Introduction Module + PBS delivered once daily and PBS trigger messages
    Arm Title
    Condition 6: Craving daily+Craving trigger
    Arm Type
    Experimental
    Arm Description
    EMA + Introduction Module + Craving reduction delivered once daily and craving reduction trigger messages
    Arm Title
    Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger
    Arm Type
    Experimental
    Arm Description
    EMA + Introduction Module + Craving reduction delivered once daily, craving reduction trigger messages, PBS delivered once daily, and PBS trigger messages
    Arm Title
    Condition 8: No daily or trigger craving or PBS
    Arm Type
    Other
    Arm Description
    EMA + Introduction Module + no other messages
    Intervention Type
    Behavioral
    Intervention Name(s)
    Condition 1: Craving daily+PBS daily
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Condition 2: Craving daily+PBS trigger
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Condition 3: Craving trigger+PBS daily
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Condition 4: Craving trigger+PBS trigger
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Condition 5: PBS daily+ PBS trigger
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Condition 6: Craving daily+Craving trigger
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Condition 8: No daily or trigger craving or PBS
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Negative consequences associated with alcohol, marijuana, and simultaneous alcohol and marijuana (SAM) use
    Description
    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
    Title
    Protective behavioral strategies for alcohol
    Description
    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
    Title
    Protective behavioral strategies for marijuana
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Feasibility - study attrition
    Description
    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
    Through study completion, an average of 5 months
    Title
    Feasibility - response rate
    Description
    Number of completed prompts across 6-week EMA
    Time Frame
    Week 7
    Title
    Feasibility - module completion rate
    Description
    Completion of introduction module focused on psychoeducation, personalized feedback, and goal setting
    Time Frame
    Week 7
    Title
    Feasibility - acceptability of the intervention
    Description
    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
    Title
    Feasibility - perceived helpfulness of intervention strategies
    Description
    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
    Title
    Feasibility - intervention implementation
    Description
    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
    Title
    Feasibility - intervention engagement
    Description
    Intervention engagement will be assessed by examining participant's use of intervention strategies.
    Time Frame
    Week 7
    Title
    Feasibility - goal attainment
    Description
    Participants will be asked to report whether they attained or made progress on goals identified in the a-EMI introduction module.
    Time Frame
    Through study completion, an average of 5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristina Phillips, PhD
    Phone
    808-432-4687
    Email
    kristina.t.phillips@kp.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan Lai, BSN
    Phone
    808-476-1747
    Email
    jonathan.ws.lai@kp.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kristina Phillips, PhD
    Organizational Affiliation
    Kaiser Permanente Hawaii
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults

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