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Master Mind Program Evaluation Study (MasterMind)

Primary Purpose

Substance Abuse, Mindfulness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Master Mind
Sponsored by
Innovation Research & Training
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English Fluency

Exclusion Criteria:

-

Sites / Locations

  • innovation Research & Training

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Wait-List Control

Arm Description

Master Mind is a 25-lesson elementary school, mindfulness education substance abuse prevention program for 4th and 5th grade classrooms.

Business as usual

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Student Consumer Satisfaction Questionnaire
Assesses the overall opinions of students in the intervention group about the Master Mind lessons and activities.
Teacher Program Feasibility Questionnaire
Assesses the overall opinions of teachers in the intervention group related to feasibility of the Master Mind program.

Full Information

First Posted
July 5, 2017
Last Updated
December 6, 2019
Sponsor
Innovation Research & Training
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03212066
Brief Title
Master Mind Program Evaluation Study
Acronym
MasterMind
Official Title
Elementary School Mindfulness-Based Substance Use Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovation Research & Training
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Mindfulness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
518 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Master Mind is a 25-lesson elementary school, mindfulness education substance abuse prevention program for 4th and 5th grade classrooms.
Arm Title
Wait-List Control
Arm Type
No Intervention
Arm Description
Business as usual
Intervention Type
Behavioral
Intervention Name(s)
Master Mind
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in score on Positive and Negative Affect Scale for Children - Shortened Version (PANAS)
Description
Assesses students' experiences of positive and negative emotions.
Time Frame
6 weeks
Title
Change in score on Self-Report Coping Measure
Description
Assesses students' coping in response to stressors.
Time Frame
6 weeks
Title
Change in score on Intentions to use alcohol or tobacco
Description
Assesses students' intentions to use alcohol or tobacco in the future.
Time Frame
6 weeks
Title
Change in score on Willingness to use alcohol or tobacco
Description
Assesses students' willingness to use alcohol or tobacco by responding to imagined situations.
Time Frame
6 weeks
Title
Change in score on The Peer Relations questionnaire
Description
Assesses students' feelings about their classmates.
Time Frame
6 weeks
Title
Change in score on The Emotional Self-Efficacy Scale for Youth
Description
Assesses students' beliefs about their ability to manage emotions.
Time Frame
6 weeks
Title
Change in scores on Flanker Inhibitory Control and Attention Test
Description
Assesses students' executive functioning skills via a performance task.
Time Frame
6 weeks
Title
Change in score on Childhood Executive Functioning Inventory (CHEXI)
Description
Assesses teacher ratings of students' executive functioning.
Time Frame
6 weeks
Title
Change in score on The Child Behavior Scale (CBS)
Description
Assesses teacher ratings of student behavior and peer relationships.
Time Frame
6 weeks
Title
Change in Iowa Conners Teacher Rating Scale
Description
Assesses teacher ratings of students' inattention and aggression.
Time Frame
6 weeks
Title
Change in Iowa Conners Teacher Rating Scale
Description
Assesses teacher ratings of students' inattention and aggression.
Time Frame
14 weeks
Title
Change in Student grades
Description
Teachers will be asked to provide grades for each student for Math and Language Arts.
Time Frame
6 weeks
Title
Change in Student grades
Description
Teachers will be asked to provide grades for each student for Math and Language Arts.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Student Consumer Satisfaction Questionnaire
Description
Assesses the overall opinions of students in the intervention group about the Master Mind lessons and activities.
Time Frame
6 weeks
Title
Teacher Program Feasibility Questionnaire
Description
Assesses the overall opinions of teachers in the intervention group related to feasibility of the Master Mind program.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English Fluency Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Parker, PhD
Organizational Affiliation
Innovation Research & Training
Official's Role
Principal Investigator
Facility Information:
Facility Name
innovation Research & Training
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27057208
Citation
Parker AE, Kupersmidt JB, Mathis ET, Scull TM, Sims C. The impact of mindfulness education on elementary school students: Evaluation of the Master Mind Program. Adv Sch Ment Health Promot. 2014;7(3):184-204. doi: 10.1080/1754730X.2014.916497. Epub 2014 May 19.
Results Reference
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Master Mind Program Evaluation Study

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