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Master Mind Program Evaluation Study (MasterMind)

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ClinicalTrials.gov Identifier: NCT03212066
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Innovation Research & Training

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.

Condition or disease Intervention/treatment Phase
Substance Abuse Mindfulness Behavioral: Master Mind Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 920 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Elementary School Mindfulness-Based Substance Use Prevention Program
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English Fluency

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212066


Contacts
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Contact: Alison Parker, PhD 919-493-7700 aparker@irtinc.us
Contact: Janis Kupersmidt, PhD 919-493-7700 jkupersmidt@irtinc.us

Locations
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United States, North Carolina
innovation Research & Training Recruiting
Durham, North Carolina, United States, 27713
Contact: Alison Parker, PhD    919-493-7700    aparker@irtinc.us   
Principal Investigator: Alison Parker, PhD         
Sub-Investigator: Janis Kupersmidt, PhD         
Sponsors and Collaborators
Innovation Research & Training
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Alison Parker, PhD Innovation Research & Training

Publications:
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Responsible Party: Innovation Research & Training
ClinicalTrials.gov Identifier: NCT03212066     History of Changes
Other Study ID Numbers: R44AA021342 ( U.S. NIH Grant/Contract )
R44AA021342 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders