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Completed

NCT Number: NCT03212066

Master Mind Program Evaluation Study

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.

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Key information

Conditions

Substance Abuse Chemically-Induced Disorders Mental Disorders Mindfulness Substance-Related Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

innovation Research & Training

Durham, North Carolina, 27713, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English Fluency

Exclusion criteria

-

Treatment and study plan

Master Mind

Behavioral

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 outcomes

  1. 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.

  2. Change in score on Self-Report Coping Measure

    Time frame: 6 weeks

    Assesses students' coping in response to stressors.

  3. 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.

  4. 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.

  5. Change in score on The Peer Relations questionnaire

    Time frame: 6 weeks

    Assesses students' feelings about their classmates.

  6. Change in score on The Emotional Self-Efficacy Scale for Youth

    Time frame: 6 weeks

    Assesses students' beliefs about their ability to manage emotions.

  7. Change in scores on Flanker Inhibitory Control and Attention Test

    Time frame: 6 weeks

    Assesses students' executive functioning skills via a performance task.

  8. Change in score on Childhood Executive Functioning Inventory (CHEXI)

    Time frame: 6 weeks

    Assesses teacher ratings of students' executive functioning.

  9. Change in score on The Child Behavior Scale (CBS)

    Time frame: 6 weeks

    Assesses teacher ratings of student behavior and peer relationships.

  10. Change in Iowa Conners Teacher Rating Scale

    Time frame: 6 weeks

    Assesses teacher ratings of students' inattention and aggression.

  11. Change in Iowa Conners Teacher Rating Scale

    Time frame: 14 weeks

    Assesses teacher ratings of students' inattention and aggression.

  12. Change in Student grades

    Time frame: 6 weeks

    Teachers will be asked to provide grades for each student for Math and Language Arts.

  13. Change in Student grades

    Time frame: 14 weeks

    Teachers will be asked to provide grades for each student for Math and Language Arts.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Innovation Research & Training

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Elementary School Mindfulness-Based Substance Use Prevention Program

Acronym: MasterMind

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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