Biopsychosocial Outcomes of Mindfulness-based Instruction

NCT ID: NCT05787483

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-14
• Study Completion Date: 2024-10-16

Brief Summary

Over 20% of adolescents living in the United States have a diagnosable psychiatric disorder. However, most adolescents who need mental health services do not receive them due to many reasons, including low resources in families and communities, stigma, lack of mental health providers, and other barriers to mental health care access. Alabama currently ranks 50th in access to mental healthcare and 51st (LAST) in mental healthcare provider availability with only one mental healthcare provider for every 920 persons in need. Most adolescents attend school, so delivering mental health services in the school setting eliminates many barriers to mental health care access. From the point of prevention, participation in universal social and emotional learning (SEL) programs within the school setting improves social and emotional skills, behaviors, attitudes, and academic performance. Mindfulness-based instruction is a promising approach to SEL for improving psychological functioning that is evidence-based, widely available, and scalable to various populations and settings. This project aims to investigate whether a SEL program that incorporates mindfulness-based instruction (MindUP) leads to improvements in not only self-reported well-being (i.e., anxiety, mindful attention, perceived stress, and positive and negative affect), but also objectively measured executive functioning, academic achievement, and regulation of stress physiology. The investigators will partner with schools that serve historically underserved students to test the effectiveness of the MindUP program in 5th and 6th graders. This study has the potential to benefit underserved students and their teachers who will receive training on sustainable implementation of the MindUP curriculum.

Conditions

Specific Learning Disability; Mental Health Issue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

active control group

business as usual; regular wellness or SEL classes

Group Type: ACTIVE_COMPARATOR

active control group

Intervention Type: BEHAVIORAL

business as usual; regular wellness or SEL classes

MindUP group

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 Type: EXPERIMENTAL

MindUP group

Intervention Type: BEHAVIORAL

MindUP is a Collaborative for Academic, Social, and Emotional Learning SELect (CASEL) program, meaning the program is evidence-based and meets the adequate criteria for developing students' social and emotional competence at the highest level. MindUP addresses all five components of the CASEL SEL Framework: self-awareness, social awareness, self-management, responsible decision-making, and relationship skills (CASEL, 2020). Students are taught how the workings of the brain are related to emotions, behaviors, decision making, and learning. MindUP is the first program to provide clear instruction in both SEL and mindfulness.

Interventions

MindUP group

MindUP is a Collaborative for Academic, Social, and Emotional Learning SELect (CASEL) program, meaning the program is evidence-based and meets the adequate criteria for developing students' social and emotional competence at the highest level. MindUP addresses all five components of the CASEL SEL Framework: self-awareness, social awareness, self-management, responsible decision-making, and relationship skills (CASEL, 2020). Students are taught how the workings of the brain are related to emotions, behaviors, decision making, and learning. MindUP is the first program to provide clear instruction in both SEL and mindfulness.

Intervention Type: BEHAVIORAL

active control group

business as usual; regular wellness or SEL classes

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Fifth grade students at i3 Academy
• fifth and sixth grade students at Tarrant Intermediate School
• 6th through 8th grade students at Spring Valley School
• All students enrolled in general education will be invited to participate in the study

Exclusion Criteria

• those with medical, developmental, or psychiatric conditions that compromise their ability to provide valid self-reports or complete other study procedures
• only one child per family will be allowed to participate to avoid dependency in data due to clustering within families

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Caroline G. Richter

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Spring Valley School

Birmingham, Alabama, United States

Countries

United States

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Other Identifiers

UAB

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300010662

Identifier Type: -

Identifier Source: org_study_id