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Biopsychosocial Outcomes of Mindfulness-based Instruction (MindUP)

Primary Purpose

Specific Learning Disability, Mental Health Issue

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MindUP group
active control group
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Specific Learning Disability focused on measuring mindfulness-based-intervention, social and emotional learning, anxiety, stress, affect, executive function, academic achievement

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Spring Valley School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MindUP group

active control group

Arm Description

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.

business as usual; regular wellness or SEL classes

Outcomes

Primary Outcome Measures

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).
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").

Secondary Outcome Measures

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).
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).
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.)
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.)
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.)

Full Information

First Posted
March 1, 2023
Last Updated
October 11, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05787483
Brief Title
Biopsychosocial Outcomes of Mindfulness-based Instruction
Acronym
MindUP
Official Title
Evaluating Biopsychosocial Outcomes of Mindfulness-based Instruction in Adolescence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Learning Disability, Mental Health Issue
Keywords
mindfulness-based-intervention, social and emotional learning, anxiety, stress, affect, executive function, academic achievement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MindUP group
Arm Type
Experimental
Arm Description
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.
Arm Title
active control group
Arm Type
Active Comparator
Arm Description
business as usual; regular wellness or SEL classes
Intervention Type
Behavioral
Intervention Name(s)
MindUP group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
active control group
Intervention Description
business as usual; regular wellness or SEL classes
Primary Outcome Measure Information:
Title
Anxiety - change
Description
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, after the completion of the program, and a three-month follow-up
Title
Mindful attention - change
Description
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
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 Measure Information:
Title
Positive and negative affect - change
Description
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
12 times - once per week
Title
Stress self-report - change
Description
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
Title
Cortisol - change
Description
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
Title
Dehydroepiandrosterone (DHEA) - change
Description
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
Title
C-reactive protein (CRP) - change
Description
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
Other Pre-specified Outcome Measures:
Title
Executive function: Flanker Inhibitory Control & Attention Test (Flanker) - change
Description
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
Title
Executive function: Dimensional Change Card Sort Test (DCCS) - change
Description
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
Title
Behavior Regulation - change
Description
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
Title
Emotion Regulation - change
Description
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
Title
Academic achievement - change
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Spring Valley School
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Biopsychosocial Outcomes of Mindfulness-based Instruction

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