Master Mind Program Evaluation Study

Study Overview
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Brief Summary
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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.

Official Title
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Elementary School Mindfulness-Based Substance Use Prevention Program

Conditions
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Substance Abuse, Mindfulness

Intervention / Treatment
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* Behavioral: Master Mind


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English Fluency Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Master Mind is a 25-lesson elementary school, mindfulness education substance abuse prevention program for 4th and 5th grade classrooms. | Behavioral: Master Mind<br>* 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.<br>|
| No Intervention: Wait-List Control<br>Business as usual | |

What is the study measuring?
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Primary Outcome Measures

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