Biopsychosocial Outcomes of Mindfulness-based Instruction

NCT05787483 | Completed

• 2 other identifiers: IRB-300010662UAB
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

mindfulness-based-intervention; social and emotional learning; anxiety; stress; affect; executive function; academic achievement

Outcome Measures

Primary Outcomes (2)

• Anxiety - change

  Autonomic reactions subscale of Children's Test Anxiety Scale (CTAS): has 9-items that ask the students to respond in terms of how they think, feel, or act during a test. All the questions start with the same stem, ''While I am taking tests…'' (e.g., "I feel nervous"; "My head hurts"). Students are asked to choose between four response options (i.e., almost never, 1; some of the time, 2; most of the time, 3; almost always, 4).

  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

• Mindful attention - change

  Mindful Attention Awareness Scale-Children (MAAS-C): has 15 items and measures the frequency of mindful states over time. Students are asked to rate how frequently they experience certain state in a 6-point Likert scale ranging from almost never to almost always (e.g., "I could be feeling a certain way and not realize it until later"; "I break or spill things because of carelessness, not paying attention, or thinking of something else").

  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 (5)

• Positive and negative affect - change

  12 times - once per week

• Stress self-report - change

  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

• Cortisol - change

  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

• Dehydroepiandrosterone (DHEA) - change

  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

• C-reactive protein (CRP) - change

  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 (5)

• Executive function: Flanker Inhibitory Control & Attention Test (Flanker) - change

  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

• Executive function: Dimensional Change Card Sort Test (DCCS) - change

  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

• Behavior Regulation - change

  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

Study Arms (2)

MindUP group

EXPERIMENTAL

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.

Behavioral: MindUP group

active control group

ACTIVE COMPARATOR

business as usual; regular wellness or SEL classes

Behavioral: active control group

Interventions

MindUP group 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.

MindUP group

active control group BEHAVIORAL

business as usual; regular wellness or SEL classes

active control group

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Spring Valley School

Birmingham, Alabama, 35211, United States

Location

Related Publications (14)

• Belliveau C, Nagy C, Escobar S, Mechawar N, Turecki G, Rej S, Torres-Platas SG. Effects of Mindfulness-Based Cognitive Therapy on Peripheral Markers of Stress and Inflammation in Older-Adults With Depression and Anxiety: A Parallel Analysis of a Randomized Controlled Trial. Front Psychiatry. 2021 Dec 24;12:804269. doi: 10.3389/fpsyt.2021.804269. eCollection 2021.

  PMID: 35002817 BACKGROUND

• Cummings JR, Ponce NA, Mays VM. Comparing racial/ethnic differences in mental health service use among high-need subpopulations across clinical and school-based settings. J Adolesc Health. 2010 Jun;46(6):603-6. doi: 10.1016/j.jadohealth.2009.11.221. Epub 2010 Feb 4.

  PMID: 20472219 BACKGROUND

• Dunning DL, Griffiths K, Kuyken W, Crane C, Foulkes L, Parker J, Dalgleish T. Research Review: The effects of mindfulness-based interventions on cognition and mental health in children and adolescents - a meta-analysis of randomized controlled trials. J Child Psychol Psychiatry. 2019 Mar;60(3):244-258. doi: 10.1111/jcpp.12980. Epub 2018 Oct 22.

  PMID: 30345511 BACKGROUND

• Schonert-Reichl KA, Oberle E, Lawlor MS, Abbott D, Thomson K, Oberlander TF, Diamond A. Enhancing cognitive and social-emotional development through a simple-to-administer mindfulness-based school program for elementary school children: a randomized controlled trial. Dev Psychol. 2015 Jan;51(1):52-66. doi: 10.1037/a0038454.

  PMID: 25546595 BACKGROUND

• Morganti A, Ambrosi B, Sala C, Cianci L, Bochicchio D, Turolo L, Zanchetti A. Effects of angiotensin II blockade on the responses of the pituitary-adrenal axis to corticotropin-releasing factor in humans. J Cardiovasc Pharmacol. 1987;10 Suppl 7:S167-9. doi: 10.1097/00005344-198706107-00038.

  PMID: 2485058 BACKGROUND

• Wren, D. G., & Benson, J. (2004). Measuring test anxiety in children: Scale development and internal construct validation. Anxiety, Stress & Coping, 17(3), 227-240. https://doi.org/10.1080/10615800412331292606

  BACKGROUND

• Lawlor, M. S., Schonert-Reichl, K. A., Gadermann, A. M., & Zumbo, B. D. (2014). A validation study of the mindful attention awareness scale adapted for children. Mindfulness, 5(6), 730-741. https://doi.org/10.1007/s12671-013-0228-4

  BACKGROUND

• Laurent, J., Catanzaro, S. J., Joiner Jr., T. E., Rudolph, K. D., Potter, K. I., Lambert, S., Osborne, L., & Gathright, T. (1999). A measure of positive and negative affect for children: Scale development and preliminary validation. Psychological Assessment, 11(3), 326-338. https://doi.org/10.1037/1040-3590.11.3.326

  BACKGROUND

• White, B. P., & White, B. P. (2014). The perceived stress scale for children: A pilot study in a sample of 153 children. International Journal of Pediatrics and Child Health, 2(2), 45-52. https://doi.org/10.12974/2311-8687.2014.02.02.4

  BACKGROUND

• Gioia, G. A., Isquith, P. K., Guy, S. C., & Kenworthy, L. (2015). BRIEF-2: Behavior rating inventory of executive function: Professional manual. Psychological Assessment Resources.

  BACKGROUND

• Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.

  PMID: 23479546 BACKGROUND

• Rueda MR, Fan J, McCandliss BD, Halparin JD, Gruber DB, Lercari LP, Posner MI. Development of attentional networks in childhood. Neuropsychologia. 2004;42(8):1029-40. doi: 10.1016/j.neuropsychologia.2003.12.012.

  PMID: 15093142 BACKGROUND

• Zelazo PD. The Dimensional Change Card Sort (DCCS): a method of assessing executive function in children. Nat Protoc. 2006;1(1):297-301. doi: 10.1038/nprot.2006.46.

  PMID: 17406248 BACKGROUND

• Schrank, F. A., Mather, N., & McGrew, K. S. (2014). Woodcock-Johnson IV tests of achievement. Rolling Meadows, IL: Riverside.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 28, 2023
• Study Start: August 14, 2023
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)