A Real-time, Contextual Intervention Using Mobile Technology to Reduce Marijuana Use in Youth (MOMENT)
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| First Received Date ICMJE | January 4, 2013 | ||||||||
| Last Updated Date | January 4, 2013 | ||||||||
| Start Date ICMJE | January 2013 | ||||||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Real-time, Contextual Intervention Using Mobile Technology to Reduce Marijuana Use in Youth | ||||||||
| Official Title ICMJE | A Real-time, Contextual Intervention Using PDAs to Reduce Marijuana Use in Youth | ||||||||
| Brief Summary | 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. |
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| 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
(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?
2c. Will improvements in both levels of outcomes be greater with MOMENT vs. No-feedback? |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Marijuana Abuse | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 108 | ||||||||
| Estimated Completion Date | December 2015 | ||||||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 15 Years to 24 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01762696 | ||||||||
| Other Study ID Numbers ICMJE | 1R34DA030535-01A1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Lydia Shrier, Children's Hospital Boston | ||||||||
| Study Sponsor ICMJE | Children's Hospital Boston | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital Boston | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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