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

Marijuana Abuse Clinical Trial

— MOMENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762696
• Other study ID #: 1R34DA030535-01A1
• Status: Completed
• Phase: N/A
• First received: January 4, 2013
• Last updated: December 9, 2016
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: December 2016
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 24 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marijuana Abuse

Intervention

Behavioral:
• MET
Motivational Enhancement Therapy only
• 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

Locations

Country	Name	City	State
United States	Boston Children's Hospital Adolescent/Young Adult Medical Clinic	Boston	Massachusetts
United States	Martha Eliot Health Center Adolescent Clinic	Jamaica Plain	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marijuana desire	Desire to use marijuana when in top-3 trigger context	3 months	No
Primary	Marijuana use following trigger exposure	Marijuana use following exposure to top-3 trigger context	3 months	No
Primary	Frequency of marijuana use	Marijuana use events/day	3 months	No
Primary	Percent days abstinent	30-day percent days abstinent from marijuana use	3 months	No
Primary	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	3 months	No