Biopsychosocial Outcomes of Mindfulness-based Instruction

Mental Health Issue Clinical Trial

— MindUP  

Official title:

Evaluating Biopsychosocial Outcomes of Mindfulness-based Instruction in Adolescence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05787483
• Other study ID #: IRB-300010662
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: September 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Learning Disabilities
• Mental Health Issue

Intervention

Behavioral:
• 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.
• active control group
business as usual; regular wellness or SEL classes

Locations

Country	Name	City	State
United States	Spring Valley School	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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.

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Executive function: Flanker Inhibitory Control & Attention Test (Flanker) - change	The Flanker task from the NIH Toolbox Cognition Battery measures the child's ability to inhibit visual attention to irrelevant dimensions. The scoring procedure integrates both accuracy and reaction time. T-scores based on the participant's chronological age will be computed. T-scores range from 20 to 80 and have a mean of 50 and a standard deviation of 10. Higher scores mean a better outcome. The average time to complete the task is 4 minutes.	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	Executive function: Dimensional Change Card Sort Test (DCCS) - change	The DCCS from the NIH Toolbox Cognition Battery measures the child's ability to shift from one rule to another (the child is asked to match an object with another based on shape and then based on color). The scoring procedure integrates both accuracy and reaction time. T-scores based on the participant's chronological age will be computed. T-scores range from 20 to 80 and have a mean of 50 and a standard deviation of 10. Higher scores mean a better outcome. The average time to complete the task is 4 minutes.	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	Behavior Regulation - change	Teachers who are not responsible for teaching either group (MindUP or control) will complete the Behavior Regulation Index (BRI, 13 items) of the Behavior Rating Inventory of Executive Function (BRIEF), an ecologically valid measure of school-related executive performance. Teachers should take five minutes to complete these items per child. T-scores will be computed based on the child's chronological age. T-scores at or below 59 are considered to be within the typical range. T-scores of 60-64 are in the mildly elevated range, and scores equal to or exceeding 65 are considered to be significantly elevated. Thus, higher scores mean a worse outcome.	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	Emotion Regulation - change	Teachers who are not responsible for teaching either group (MindUP or control) will complete the Emotion Regulation Index (ERI, 16 items) of the Behavior Rating Inventory of Executive Function (BRIEF), an ecologically valid measure of school-related executive performance. Teachers should take five minutes to complete these items per child. T-scores will be computed based on the child's chronological age. T-scores at or below 59 are considered to be within the typical range. T-scores of 60-64 are in the mildly elevated range, and scores equal to or exceeding 65 are considered to be significantly elevated. Thus, higher scores mean a worse outcome.	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	Academic achievement - change	To measure academic achievement, children will complete two subtests of the Woodcock-Johnson-IV: Passage Comprehension and Calculation. In the Passage Comprehension subtest, the child is asked to determine a missing key word in a written passage. In the Calculation subtest, children are asked to complete a series of arithmetic problems arranged in order of difficulty (e.g., 5 + 2 = ?; 42 +21 +13 = ?). Children should take five minutes to complete each of the subtests. All of these five measures are standardized and provide age-corrected standard scores, for which the normative mean is 100 and the standard deviation is 15.	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
Primary	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
Primary	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	Positive and negative affect - change	The investigators will assess children's positive and negative affect weekly (12 times) using the Positive and Negative Affect Scale - child version. This will allow us to observe if there is change in student's affect due to the intervention. This is a 30-item scale in which the student is asked to rate in a 5-item scale ("not much or not al all" to "a lot") how much they felt certain positive and negative feelings and emotions during the past weeks (e.g., happy, sad, excited, ashamed, energetic, calm).	12 times - once per week
Secondary	Stress self-report - change	Self-report measure of perceived stress (Perceived Stress Scale - Child, PSS-C): has 13 items and is a measure of perceived stress developed for children aged 5 to 18 years. Students are asked questions about their feelings and thoughts during the previous week (e.g., "In the last week, how often did you feel rushed or hurried?"). Items are rated on a four-point scale from "0" (Never) to "3" (Very Often).	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	Cortisol - change	Stress and inflammation biomarkers in the students' saliva: Hypothalamic-pituitary-adrenocortical (HPA) regulation and inflammation will be assessed by measuring the presence of cortisol. A sample of 1ml of saliva will be collected at each time point, three times within one day (9 A.M., 11:30 A.M., 2:30 P.M.)	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	Dehydroepiandrosterone (DHEA) - change	Stress and inflammation biomarkers in the students' saliva: Hypothalamic-pituitary-adrenocortical (HPA) regulation and inflammation will be assessed by measuring the presence of DHEA. A sample of 1ml of saliva will be collected at each time point, three times within one day (9 A.M., 11:30 A.M., 2:30 P.M.)	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	C-reactive protein (CRP) - change	Stress and inflammation biomarkers in the students' saliva: Hypothalamic-pituitary-adrenocortical (HPA) regulation and inflammation will be assessed by measuring the presence of CRP. A sample of 1ml of saliva will be collected at each time point, three times within one day (9 A.M., 11:30 A.M., 2:30 P.M.)	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