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

Primary Purpose

Marijuana Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MET
MOMENT
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse focused on measuring marijuana, intervention, adolescent, young adult, primary care, mobile

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital Adolescent/Young Adult Medical Clinic
  • Martha Eliot Health Center Adolescent Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MET only

MOMENT

Arm Description

Motivational Enhancement Therapy only

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

Outcomes

Primary Outcome Measures

Marijuana desire
Desire to use marijuana when in top-3 trigger context
Marijuana use following trigger exposure
Marijuana use following exposure to top-3 trigger context
Frequency of marijuana use
Marijuana use events/day
Percent days abstinent
30-day percent days abstinent from marijuana use
Motivation to reduce marijuana use
Daily score on 3 scales - readiness to reduce marijuana use, importance of reducing use, and confidence in ability to reduce use

Secondary Outcome Measures

Full Information

First Posted
January 4, 2013
Last Updated
December 9, 2016
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01762696
Brief Title
A Real-time, Contextual Intervention Using Mobile Technology to Reduce Marijuana Use in Youth
Acronym
MOMENT
Official Title
A Real-time, Contextual Intervention Using PDAs to Reduce Marijuana Use in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse
Keywords
marijuana, intervention, adolescent, young adult, primary care, mobile

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MET only
Arm Type
Active Comparator
Arm Description
Motivational Enhancement Therapy only
Arm Title
MOMENT
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
MET
Other Intervention Name(s)
Motivational Enhancement Therapy
Intervention Description
Motivational Enhancement Therapy only
Intervention Type
Behavioral
Intervention Name(s)
MOMENT
Intervention Description
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
Primary Outcome Measure Information:
Title
Marijuana desire
Description
Desire to use marijuana when in top-3 trigger context
Time Frame
3 months
Title
Marijuana use following trigger exposure
Description
Marijuana use following exposure to top-3 trigger context
Time Frame
3 months
Title
Frequency of marijuana use
Description
Marijuana use events/day
Time Frame
3 months
Title
Percent days abstinent
Description
30-day percent days abstinent from marijuana use
Time Frame
3 months
Title
Motivation to reduce marijuana use
Description
Daily score on 3 scales - readiness to reduce marijuana use, importance of reducing use, and confidence in ability to reduce use
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia A Shrier, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital Adolescent/Young Adult Medical Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Martha Eliot Health Center Adolescent Clinic
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

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

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