Biopsychosocial Outcomes of Mindfulness-based Instruction

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating Biopsychosocial Outcomes of Mindfulness-based Instruction in Adolescence

Conditions
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Specific Learning Disability, Mental Health Issue

Intervention / Treatment
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* Behavioral: MindUP group
* Behavioral: active control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MindUP group<br>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<br>* 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.<br>|
| Active Comparator: active control group<br>business as usual; regular wellness or SEL classes | Behavioral: active control group<br>* business as usual; regular wellness or SEL classes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness-based-intervention, social and emotional learning, anxiety, stress, affect, executive function, academic achievement