Substance AbuseMasterMindNCT03212066
Master Mind Program Evaluation Study
A study testing Master Mind in people with Substance Abuse and Mindfulness, run by Innovation Research & Training at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Mindfulness
- What is being tested?
- Master Mind
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- English Fluency
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
innovation Research & Training
Durham, North Carolina, 27713
About this study
Official title: Elementary School Mindfulness-Based Substance Use Prevention Program
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.
- Conditions
- Substance Abuse, Mindfulness
- Being tested
- Master Mind
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Master MindBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Master Mind is a 25-lesson elementary school, mindfulness education substance abuse prevention program for 4th and 5th grade classrooms. Receives: Behavioral: Master Mind |
| Wait-List Control | No intervention | Business as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on Positive and Negative Affect Scale for Children - Shortened Version (PANAS)
Assesses students' experiences of positive and negative emotions.
Measured: 6 weeks
Change in score on Self-Report Coping Measure
Assesses students' coping in response to stressors.
Measured: 6 weeks
Change in score on Intentions to use alcohol or tobacco
Assesses students' intentions to use alcohol or tobacco in the future.
Measured: 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.
Measured: 6 weeks
Change in score on The Peer Relations questionnaire
Assesses students' feelings about their classmates.
Measured: 6 weeks
Change in score on The Emotional Self-Efficacy Scale for Youth
Assesses students' beliefs about their ability to manage emotions.
Measured: 6 weeks
Change in scores on Flanker Inhibitory Control and Attention Test
Assesses students' executive functioning skills via a performance task.
Measured: 6 weeks
Change in score on Childhood Executive Functioning Inventory (CHEXI)
Assesses teacher ratings of students' executive functioning.
Measured: 6 weeks
Change in score on The Child Behavior Scale (CBS)
Assesses teacher ratings of student behavior and peer relationships.
Measured: 6 weeks
Change in Iowa Conners Teacher Rating Scale
Assesses teacher ratings of students' inattention and aggression.
Measured: 6 weeks
Change in Iowa Conners Teacher Rating Scale
Assesses teacher ratings of students' inattention and aggression.
Measured: 14 weeks
Change in Student grades
Teachers will be asked to provide grades for each student for Math and Language Arts.
Measured: 6 weeks
Change in Student grades
Teachers will be asked to provide grades for each student for Math and Language Arts.
Measured: 14 weeks
Secondary outcomes (2)
Student Consumer Satisfaction Questionnaire
Assesses the overall opinions of students in the intervention group about the Master Mind lessons and activities.
Measured: 6 weeks
Teacher Program Feasibility Questionnaire
Assesses the overall opinions of teachers in the intervention group related to feasibility of the Master Mind program.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start23 Aug 2017
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Research & Training
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Alison Parker, PhD, Principal investigator, Innovation Research & Training
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212066
- Sponsor's protocol ID
- R44AA021342
- Other IDs
- R44AA021342
- Acronym
- MasterMind
- Status last verified
- Dec 2019
- First submitted
- 5 Jul 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27057208
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elementary School Mindfulness-Based Substance Use Prevention Program
- ClinicalTrials.gov ID
- NCT03212066
- Acronym / sponsor ID
- MasterMind / R44AA021342
- Conditions
- Substance Abuse, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Innovation Research & TrainingUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Master MindMaster Mind is a 25-lesson elementary school, mindfulness education substance abuse prevention program for 4th and 5th grade classrooms. |
| Wait-List Control | No intervention | –Business as usual |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- English Fluency
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Master MindMaster 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. | Behavioural | Intervention |
Primary outcome
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.
Change in score on Self-Report Coping Measure
Time frame: 6 weeks
Assesses students' coping in response to stressors.
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.
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.
Change in score on The Peer Relations questionnaire
Time frame: 6 weeks
Assesses students' feelings about their classmates.
Change in score on The Emotional Self-Efficacy Scale for Youth
Time frame: 6 weeks
Assesses students' beliefs about their ability to manage emotions.
Change in scores on Flanker Inhibitory Control and Attention Test
Time frame: 6 weeks
Assesses students' executive functioning skills via a performance task.
Change in score on Childhood Executive Functioning Inventory (CHEXI)
Time frame: 6 weeks
Assesses teacher ratings of students' executive functioning.
Change in score on The Child Behavior Scale (CBS)
Time frame: 6 weeks
Assesses teacher ratings of student behavior and peer relationships.
Change in Iowa Conners Teacher Rating Scale
Time frame: 6 weeks
Assesses teacher ratings of students' inattention and aggression.
Change in Iowa Conners Teacher Rating Scale
Time frame: 14 weeks
Assesses teacher ratings of students' inattention and aggression.
Change in Student grades
Time frame: 6 weeks
Teachers will be asked to provide grades for each student for Math and Language Arts.
Change in Student grades
Time frame: 14 weeks
Teachers will be asked to provide grades for each student for Math and Language Arts.
2 secondary outcomes
Student Consumer Satisfaction Questionnaire
Time frame: 6 weeks
Teacher Program Feasibility Questionnaire
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Background: PubMed 27057208Parker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Parker, PhD principal investigator
Innovation Research & Training
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Master Mind in people with Substance Abuse and Mindfulness, run by Innovation Research & Training at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on Positive and Negative Affect Scale for Children - Shortened Version (PANAS) (time frame: 6 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019; AzTrials last refreshed its copy on 29 Oct 2026.