A Real-time, Contextual Intervention Using Mobile Technology to Reduce Marijuana Use in Youth (MOMENT)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Marijuana Abuse	Behavioral: MET; Behavioral: MOMENT	Not Applicable

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 youth to one of two arms (goal 30 per arm completing 3-month follow-up): 1) MOMENT (MET + momentary self-monitoring + context-dependent feedback), or 2) MET-only. The two study arms will permit evaluation of the 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. 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:

2. 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?

1. 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.
2. The increase in motivation to reduce or discontinue use will be greater at three months.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	A Real-time, Contextual Intervention Using PDAs to Reduce Marijuana Use in Youth
Study Start Date :	May 2013
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	May 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: MET only; Motivational Enhancement Therapy only	Behavioral: MET; Motivational Enhancement Therapy only; Other Name: Motivational Enhancement Therapy
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; Motivational Enhancement Therapy only; Other Name: Motivational Enhancement Therapy Behavioral: 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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Marijuana desire [ Time Frame: 3 months ]
   Desire to use marijuana when in top-3 trigger context
2. Marijuana use following trigger exposure [ Time Frame: 3 months ]
   Marijuana use following exposure to top-3 trigger context
3. Frequency of marijuana use [ Time Frame: 3 months ]
   Marijuana use events/day
4. Percent days abstinent [ Time Frame: 3 months ]
   30-day percent days abstinent from marijuana use
5. Motivation to reduce marijuana use [ Time Frame: 3 months ]
   Daily score on 3 scales - readiness to reduce marijuana use, importance of reducing use, and confidence in ability to reduce use

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	15 Years to 24 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Boston Children's Hospital Adolescent/Young Adult Medical Clinic
Boston, Massachusetts, United States, 02115
Martha Eliot Health Center Adolescent Clinic
Jamaica Plain, Massachusetts, United States, 02130

Sponsors and Collaborators

Boston Children’s Hospital

Investigators

Principal Investigator:	Lydia A Shrier, MD, MPH	Boston Children’s Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Lydia Shrier, Attending Physician, Adolescent Medicine, Boston Children's Hospital
ClinicalTrials.gov Identifier:	NCT01762696 History of Changes
Other Study ID Numbers:	1R34DA030535-01A1 ( U.S. NIH Grant/Contract )
First Posted:	January 8, 2013
Last Update Posted:	December 12, 2016
Last Verified:	December 2016

Keywords provided by Lydia Shrier, Boston Children's Hospital:

marijuana; intervention; adolescent, young adult; primary care; mobile

Additional relevant MeSH terms:

Marijuana Abuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders