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Mindfulness-Based Instruction for Mental Health Issues in Adolescents (MindUP Trial)

N/A

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up

Awards & highlights

MindUP Trial Summary

This trial will study if a program that combines social/emotional learning with mindfulness-based instruction can help improve mental health, executive functioning, academic performance, & stress regulation in US adolescents.

Who is the study for?

This trial is for 5th to 8th grade students at selected Alabama schools, focusing on those without conditions that affect self-reporting or study participation. It aims to help underserved communities with limited access to mental health services.Check my eligibility

What is being tested?

The effectiveness of the MindUP program—a mindfulness-based social and emotional learning (SEL) curriculum—is being tested in improving well-being, executive function, academic performance, and stress response among students.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medical treatments, traditional side effects are not applicable. However, participants may experience varying levels of engagement or stress during the activities.

MindUP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety - change

Mindful attention - change

Secondary outcome measures

C-reactive protein (CRP) - change

Cortisol - change

Dehydroepiandrosterone (DHEA) - change

+2 more

Other outcome measures

Academic achievement - change

Behavior Regulation - change

Emotion Regulation - change

+2 more

MindUP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MindUP groupExperimental Treatment1 Intervention

Teachers in the MindUP group will deliver the program lessons twice a week for 30 minutes (1 hour per week) for 12 weeks. Based on previous studies, 12 weeks should be sufficient to cover the content from the 17 lessons.

Group II: active control groupActive Control1 Intervention

business as usual; regular wellness or SEL classes

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,280,954 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve adults aged twenty or older?

"As per the requirements of this clinical trial, minors between 10 and 14 years old are allowed to partake."

Answered by AI

Are there still vacancies for participants in this medical experiment?

"Clinicaltrials.gov confirms that this medical trial, which originally launched in August 14th of 2023, is no longer enrolling patients into the study. However, there are 81 other trials presently recruiting sufferers to participate."

Answered by AI

What results is this research endeavor seeking to ascertain?

"The primary outcome of the trial, which will be tracked at five distinct times (baseline, week 4, 8 and 13, plus a three-month follow up), is an improvement in anxiety. Secondary outcomes include changes to self-assessed stress levels as measured by the Perceived Stress Scale - Child questionnaire; fluctuations in saliva Dehydroepiandrosterone (DHEA) biomarkers that indicate hypothalamic regulation & inflammation; and C reactive protein (CRP) shifts reflecting HPA activity & systemic irritation."

Answered by AI

To whom is this experimental research open?

"This particular medical trial requires 400 candidates between 10-14 years old, diagnosed with a specific learning disability. Specifically, fifth grade students at i3 Academy, fifth and sixth grade students from Tarrant Intermediate School, 6th through 8th graders from Spring Valley School are all eligible to join the study. Additionally, every student enrolled in general education will be invited to take part as well."

Answered by AI

Recent research and studies

NeurologyJournal

Cognition Assessment Using the NIH Toolbox

Weintraub, S., S. S. Dikmen, R. K. Heaton, D. S. Tulsky, P. D. Zelazo, P. J. Bauer, N. E. Carlozzi, et al.. 2013. “Cognition Assessment Using the NIH Toolbox”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/wnl.0b013e3182872ded.

clinicaltrials.govStudy

Biopsychosocial Outcomes of Mindfulness-based Instruction

Caroline G. Richter 2023. "Biopsychosocial Outcomes of Mindfulness-based Instruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05787483.

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