Health TrialsbyHealthPanel

Mindfulness-Based Substance Use Prevention (MINDS-UP)

ConditionSubstance Use
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorNew York State Psychiatric Institute

About this trial

The goal of this clinical trial is to test the feasibility, behavioral/neural mechanisms, and preliminary efficacy of "MINDfulness-based Substance Use Prevention Program," or "MINDS-UP", a novel substance use prevention meditation intervention for children and adolescents between the ages of 10 and 14. The aims of the study are:

Aim 1: Determine feasibility and acceptability of MINDS-UP as a preventive intervention via a) retention, b) attendance, c) teacher-rated participation, d) student-rated participation, e) homework completion, and f) acceptability.

Aim 2: Evaluate neuropsychological mechanisms (target engagement) of MINDS-UP.

Aim 3 (Exploratory): Assess preliminary efficacy of MINDS-UP on substance use initiation (SUI).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Youth is ages 10-14 years on the day of screening [i.e., does not turn 15 before or on the day of screening]

Youth has access to a smartphone, tablet, or computer with Wi-Fi

Youth and parent are English-speaking

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • MINDS-UP

    Behavioral

    MINDS-UP is a substance use prevention program for children/adolescents.It consists of 4 x 60-minute sessions, once weekly over 4 weeks. The four MINDS-UP classes will focus on the following: Mindfulness of Body; Mindfulness of Mind; Mindfulness of Environment/Community; Kindness, Compassion, Joy and Equanimity, respectively.

  • Prevention Plus Wellness

    Behavioral

    PPW is a standardized, empirically-based intervention for substance use prevention in adolescents ages 10-14. It consists of 1 45 minute self-administered online course.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Sport: Prevention Plus Wellness (PPW)Active comparator 1 intervention
Group B: PPW + MINDS-UPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Retention

Percent of participants who completed all study procedures among those who were randomized

Time frame
Completion of Study (up to 36 months)
2

Attendance

Percent of scheduled sessions that were completed by the participant.

Time frame
Completion of Study (up to 36 months)
3

Teacher Rated Participation

Research Assessment Package for Schools - Teacher Rated

Time frame
Completion of Study (up to 36 months)
4

Student-Rated Participation

Research Assessment Package for Schools - Student Engagement

Time frame
Completion of Study (up to 36 months)

Secondary outcomes

1

Total Problems (parent-report)

Pre-assessment to post-assessment (and 6- and 12-month follow-up) difference in the total score on the total problems subscale on the Child Behavior Checklist (CBCL), which is comprised of 98 questions; individual item scores range from 0 to 2; higher scores indicate higher amount of behavioral problems

Time frame
4-8 weeks, 6 months, and 12 months
2

ADHD Symptoms

Pre-assessment to post-assessment (and 6- and 12-month follow-up) difference in score on the ADHD Rating Scale, an 18-item parent-report assessment that measures adolescent behaviors related to ADHD (inattentiveness, hyperactivity).

Time frame
4-6 weeks, 6 months, and 12 months
3

Suicidal Thoughts/Behaviors

The C-SSRS is a gold-standard assessment tool for suicide risk. This tool will be administered at every visit.

Time frame
4-6 weeks, 6 months, 12 months
4

Alcohol sipping

Low-level and early alcohol use as characterized by the iSay Sipping Inventory. This survey characterizes low level and first/early alcohol use, including age at first sip, whether that drink was completed, and behaviors after the first sip.

Time frame
4-6 weeks, 6 months, and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York State Psychiatric Institute

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: