Trial record 7 of 113 for:    Open Studies | "Marijuana Abuse"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Lydia Shrier, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01762696
First received: January 4, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • 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

  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.

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762696

Contacts
Contact: Allegra Spalding, BS 617-355-2668 allegra.spalding@childrens.harvard.edu
Contact: Lydia A Shrier, MD, MPH 617-355-8306

Locations
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
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Lydia A Shrier, MD, MPH Children's Hospital Boston
  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 July 24, 2014