NCT03212066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
518

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 23, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

July 5, 2017

Last Update Submit

December 6, 2019

Conditions

Substance AbuseMindfulness

Outcome Measures

Primary Outcomes (13)

  • 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 Outcomes (2)

  • Student Consumer Satisfaction Questionnaire

    6 weeks

  • Teacher Program Feasibility Questionnaire

    6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Master Mind

Wait-List Control

NO INTERVENTION

Business as usual

Interventions

Master MindBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • English Fluency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

innovation Research & Training

Durham, North Carolina, 27713, United States

Location

Related 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. doi: 10.1080/1754730X.2014.916497. Epub 2014 May 19.

    PMID: 27057208BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Alison Parker, PhD

    Innovation Research & Training

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 11, 2017

Study Start

August 23, 2017

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)