A Real-time, Contextual Intervention Using Mobile Technology to Reduce Marijuana Use in Youth (MOMENT)
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Purpose
The purpose of this study is to further develop and test the Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual intervention to reduce marijuana use among primary care patients.
| Condition | Intervention |
|---|---|
|
Marijuana Abuse |
Behavioral: MET Behavioral: Mobile self-monitoring Behavioral: Motivational feedback messages |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A Real-time, Contextual Intervention Using PDAs to Reduce Marijuana Use in Youth |
- Marijuana desire [ Time Frame: 3 months ] [ Designated as safety issue: No ]Desire to use marijuana when in top-3 trigger context
- Marijuana use following trigger exposure [ Time Frame: 3 months ] [ Designated as safety issue: No ]Marijuana use following exposure to top-3 trigger context
- Frequency of marijuana use [ Time Frame: 3 months ] [ Designated as safety issue: No ]Marijuana use events/day
- Percent days abstinent [ Time Frame: 3 months ] [ Designated as safety issue: No ]30-day percent days abstinent from marijuana use
- Motivation to reduce marijuana use [ Time Frame: 3 months ] [ Designated as safety issue: No ]Daily score on 3 scales - readiness to reduce marijuana use, importance of reducing use, and confidence in ability to reduce use
| Estimated Enrollment: | 108 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: MET only
Motivational Enhancement Therapy only
|
Behavioral: MET
Other Name: Motivational Enhancement Therapy
|
|
Experimental: No feedback
Motivational Enhancement Therapy + momentary and daily mobile self-monitoring, but no feedback on triggers or use behaviors
|
Behavioral: MET
Other Name: Motivational Enhancement Therapy
Behavioral: Mobile self-monitoring
|
|
Experimental: MOMENT
The full MOMENT intervention: Motivational Enhancement Therapy + momentary and daily mobile self-monitoring + motivational feedback messages prompting participants to consider their individualized coping strategies to avoid using marijuana
|
Behavioral: MET
Other Name: Motivational Enhancement Therapy
Behavioral: Mobile self-monitoring
Behavioral: Motivational feedback messages
|
Detailed Description:
This study proposes a pilot randomized trial to further develop and test the Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual intervention to reduce marijuana use over three months in 15-to-24-year-old primary care patients who use frequently. We will randomize 108 youth to one of three arms: 1) MOMENT (MET + momentary self-monitoring + context-dependent feedback), 2) No-feedback (MET + momentary self-monitoring), or 3) MET-only. The three study arms will permit evaluation of the relative contributions of the self-monitoring and feedback components of the intervention above-and-beyond the MET and directly test the influence of the intervention on the link between momentary context and marijuana-related outcomes.
The specific aims of the study are
Specific Aim 1: Continued Feasibility Evaluation. In our preliminary work, we demonstrated that 1) youth perceive MOMENT to be easy to understand, comfortable, motivating, and helpful in reducing their marijuana use, 2) we can recruit 4 participants/month (minimum rate for the proposed study), and 3) we can successfully implement a MOMENT intervention study in the proposed recruitment sites. Based on this work, we have identified additional areas of feasibility on which to focus in the proposed study. Specifically, we aim to achieve:
1a. A signal response rate of at least 70% during each of three periods of momentary data collection - baseline, intervention, and 3-month follow-up.
1b. A diary response rate of at least 70% during each momentary data collection period
c. A retention rate of at least 80% of participants at the 3-month follow-up.
Specific Aim 2. Early-Stage Efficacy Exploration. Our preliminary work showed that both momentary and individual-level outcomes improved from baseline to three months post-intervention. The primary momentary outcomes are desire to use marijuana when in a triggering context and likelihood of use following exposure to a triggering context. The primary individual-level outcomes are number of use events/week, 30-day percent of days abstinent, dose/use event, and measures of motivation (importance of, readiness for, and confidence about reducing use). Based on the preliminary findings, we will explore these early-stage efficacy questions:
- a. Will improvements in momentary outcomes be observed with MOMENT, but not MET-only?
(1) The association between exposure to self-identified trigger contexts and momentary desire to use marijuana will be attenuated at three months, compared to pre-intervention.
(2) The likelihood of marijuana use following exposure to a trigger context will be reduced at three months.
2b. Will improvements in individual-level outcomes be greater with MOMENT vs. MET-only?
- The reduction in marijuana use frequency (events/week and 30-day percent of days abstinent) and dose (per use event) will be greater at three months.
- The increase in motivation to reduce or discontinue use will be greater at three months.
2c. Will improvements in both levels of outcomes be greater with MOMENT vs. No-feedback?
Eligibility| Ages Eligible for Study: | 15 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female between the ages of 15-24 years
- Patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Clinic or Martha Elliot Health Center Adolescent Clinic
- Ability to read and understand English
Exclusion Criteria:
- Medically or emotionally unstable, intoxicated or "high,", or otherwise unable to give consent at the time of their appointment
- Have previously participated in this study
- Does not meet the above inclusion criteria
Contacts and Locations| Contact: Allegra Spalding, BS | 617-355-2668 | allegra.spalding@childrens.harvard.edu |
| Contact: Lydia A Shrier, MD, MPH | 617-355-8306 |
| United States, Massachusetts | |
| Boston Children's Hospital Adolescent/Young Adult Medical Clinic | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Martha Eliot Health Center Adolescent Clinic | Not yet recruiting |
| Jamaica Plain, Massachusetts, United States, 02130 | |
| Principal Investigator: | Lydia A Shrier, MD, MPH | Boston Children's Hospital |
More Information
No publications provided
| Responsible Party: | Lydia Shrier, Attending Physician, Adolescent Medicine, Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT01762696 History of Changes |
| Other Study ID Numbers: | 1R34DA030535-01A1 |
| Study First Received: | January 4, 2013 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Federal Government United States: Institutional Review Board |
Keywords provided by Children's Hospital Boston:
|
marijuana intervention adolescent, young adult primary care mobile |
Additional relevant MeSH terms:
|
Marijuana Abuse Marijuana Smoking Substance-Related Disorders |
Mental Disorders Smoking Habits |
ClinicalTrials.gov processed this record on May 19, 2013