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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03212066
Other study ID # R44AA021342
Secondary ID R44AA021342
Status Completed
Phase N/A
First received
Last updated
Start date August 23, 2017
Est. completion date August 30, 2019

Study information

Verified date December 2019
Source Innovation Research & Training
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 518
Est. completion date August 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria:

- English Fluency

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States innovation Research & Training Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Innovation Research & Training National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2014 May 19. — View Citation

Outcome

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