Skip to main content
Clinical Trials/NCT05787483
NCT05787483
Completed
Not Applicable

Evaluating Biopsychosocial Outcomes of Mindfulness-based Instruction in Adolescence

University of Alabama at Birmingham1 site in 1 country68 target enrollmentAugust 14, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Specific Learning Disability
Sponsor
University of Alabama at Birmingham
Enrollment
68
Locations
1
Primary Endpoint
Anxiety - change
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 14, 2023
End Date
October 16, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Caroline G. Richter

Assistant Professor

University of Alabama at Birmingham

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

Outcomes

Primary Outcomes

Anxiety - change

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).

Mindful attention - change

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").

Secondary Outcomes

  • 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)
  • Positive and negative affect - change(12 times - once per week)
  • 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)
  • 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)

Study Sites (1)

Loading locations...

Similar Trials