Clinical trial NCT05787483: Biopsychosocial Outcomes of Mindfulness-based Instruction
Official title: Evaluating Biopsychosocial Outcomes of Mindfulness-based Instruction in Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Learning Disability
Mental Health Issue
Keywords: mindfulness-based-intervention
social and emotional learning
anxiety
stress
affect
executive function
academic achievement
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 68
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Anxiety - change
timeFrame: Five times: baseline (prior to start of the program), week 4, week 8, after the completion of the program, and a three-month follow-up
measure: Mindful attention - change
timeFrame: 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
Secondary outcomes:
measure: Positive and negative affect - change
timeFrame: 12 times - once per week
measure: Stress self-report - change
timeFrame: 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
measure: Cortisol - change
timeFrame: 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
measure: Dehydroepiandrosterone (DHEA) - change
timeFrame: 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
measure: C-reactive protein (CRP) - change
timeFrame: 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
Other outcomes:
measure: Executive function: Flanker Inhibitory Control & Attention Test (Flanker) - change
timeFrame: 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
measure: Executive function: Dimensional Change Card Sort Test (DCCS) - change
timeFrame: 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
measure: Behavior Regulation - change
timeFrame: 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
measure: Emotion Regulation - change
timeFrame: 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
measure: Academic achievement - change
timeFrame: 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
Locations:
city: Birmingham
country: United States
facility: Spring Valley School
state: Alabama
Study officials:
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