Master Mind Program Evaluation Study (MasterMind)

December 6, 2019 updated by: Innovation Research & Training

Elementary School Mindfulness-Based Substance Use Prevention Program

The purpose of this study is to conduct a randomized controlled trial to evaluate the efficacy of the Master Mind program, a mindfulness education substance abuse prevention program. The program has the goal of enhancing coping strategies and decision-making skills and preventing substance abuse in late elementary school students.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

518

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • innovation Research & Training

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English Fluency

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Master Mind is a 25-lesson elementary school, mindfulness education substance abuse prevention program for 4th and 5th grade classrooms.
Behavioral: Master Mind
Master Mind is a 25-lesson elementary school mindfulness education substance abuse prevention program. Each lesson takes approximately 15 minutes and is designed to be taught by trained teachers every day for 5 weeks.
No Intervention: Wait-List Control
Business as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in score on Positive and Negative Affect Scale for Children - Shortened Version (PANAS)
Time Frame: 6 weeks
Assesses students' experiences of positive and negative emotions.
6 weeks
Change in score on Self-Report Coping Measure
Time Frame: 6 weeks
Assesses students' coping in response to stressors.
6 weeks
Change in score on Intentions to use alcohol or tobacco
Time Frame: 6 weeks
Assesses students' intentions to use alcohol or tobacco in the future.
6 weeks
Change in score on Willingness to use alcohol or tobacco
Time Frame: 6 weeks
Assesses students' willingness to use alcohol or tobacco by responding to imagined situations.
6 weeks
Change in score on The Peer Relations questionnaire
Time Frame: 6 weeks
Assesses students' feelings about their classmates.
6 weeks
Change in score on The Emotional Self-Efficacy Scale for Youth
Time Frame: 6 weeks
Assesses students' beliefs about their ability to manage emotions.
6 weeks
Change in scores on Flanker Inhibitory Control and Attention Test
Time Frame: 6 weeks
Assesses students' executive functioning skills via a performance task.
6 weeks
Change in score on Childhood Executive Functioning Inventory (CHEXI)
Time Frame: 6 weeks
Assesses teacher ratings of students' executive functioning.
6 weeks
Change in score on The Child Behavior Scale (CBS)
Time Frame: 6 weeks
Assesses teacher ratings of student behavior and peer relationships.
6 weeks
Change in Iowa Conners Teacher Rating Scale
Time Frame: 6 weeks
Assesses teacher ratings of students' inattention and aggression.
6 weeks
Change in Iowa Conners Teacher Rating Scale
Time Frame: 14 weeks
Assesses teacher ratings of students' inattention and aggression.
14 weeks
Change in Student grades
Time Frame: 6 weeks
Teachers will be asked to provide grades for each student for Math and Language Arts.
6 weeks
Change in Student grades
Time Frame: 14 weeks
Teachers will be asked to provide grades for each student for Math and Language Arts.
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Student Consumer Satisfaction Questionnaire
Time Frame: 6 weeks
Assesses the overall opinions of students in the intervention group about the Master Mind lessons and activities.
6 weeks
Teacher Program Feasibility Questionnaire
Time Frame: 6 weeks
Assesses the overall opinions of teachers in the intervention group related to feasibility of the Master Mind program.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovation Research & Training

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2017

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R44AA021342 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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