Spring Valley School
Birmingham, Alabama, 35211, United States
NCT Number: NCT05787483
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.
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Notify Me10 year–14 year
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35211, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
business as usual; regular wellness or SEL classes
Time frame: 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
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).
Time frame: 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
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").
Time frame: 12 times - once per week
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).
Time frame: 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
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).
Time frame: 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
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.)
Time frame: 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
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.)
Time frame: 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
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.)
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
University of Alabama at Birmingham
Other
Evaluating Biopsychosocial Outcomes of Mindfulness-based Instruction in Adolescence
Acronym: MindUP
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