Health TrialsbyHealthPanel

Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults

ConditionsAlcohol DrinkingCannabis Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorKaiser Permanente

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Factorial

Treatments tested in this trial

  • Condition 1: Craving daily+PBS daily

    Behavioral

    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.

  • Condition 2: Craving daily+PBS trigger

    Behavioral

    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.

  • Condition 3: Craving trigger+PBS daily

    Behavioral

    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.

  • Condition 4: Craving trigger+PBS trigger

    Behavioral

    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.

  • Condition 5: PBS daily+ PBS trigger

    Behavioral

    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.

  • Condition 6: Craving daily+Craving trigger

    Behavioral

    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.

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

    Behavioral

    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.

  • Condition 8: No daily or trigger craving or PBS

    Behavioral

    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.

Treatment groups

136 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Condition 1: Craving daily+PBS dailyExperimental treatment 1 intervention
Group B: Condition 2: Craving daily+PBS triggerExperimental treatment 1 intervention
Group C: Condition 3: Craving trigger+PBS dailyExperimental treatment 1 intervention
Group D: Condition 4: Craving trigger+PBS triggerExperimental treatment 1 intervention
Group E: Condition 5: PBS daily+ PBS triggerExperimental treatment 1 intervention
Group F: Condition 6: Craving daily+Craving triggerExperimental treatment 1 intervention
Group G: Condition 7: Craving daily+Craving trigger+PBS daily+PBS triggerExperimental treatment 1 intervention
Group H: Condition 8: No daily or trigger craving or PBSOther 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Through study completion, an average of 5 months
2

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.

Time frame
Through study completion, an average of 5 months
3

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.

Time frame
Through study completion, an average of 5 months

Secondary outcomes

1

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.

Time frame
Through study completion, an average of 5 months
2

Feasibility - response rate

Number of completed prompts across 6-week EMA

Time frame
Week 7
3

Feasibility - module completion rate

Completion of introduction module focused on psychoeducation, personalized feedback, and goal setting

Time frame
Week 7
4

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).

Time frame
Week 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaiser Permanente

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
Apply now