Exploring the impact of mindfulness on children with mental health diagnoses
| ISRCTN | ISRCTN10476703 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10476703 |
| Secondary identifying numbers | 2086851-2 |
- Submission date
- 09/08/2024
- Registration date
- 15/08/2024
- Last edited
- 15/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study aimed to measure the impact of mindfulness-based intervention (MBI) on a clinical student population when provided in general education classrooms for elementary and middle students.
Who can participate?
Kindergarten through eighth-grade students from two schools identified with one or more of the following: autism spectrum disorder, dyslexia, attention deficit hyperactivity disorder, oppositional defiant disorder, anxiety, specific learning disability, dyslexia, or emotional disturbance
What does the study involve?
Schools are randomly assigned to the MBI or control group. The Calm & Alert intervention will begin no earlier than the second week of school to allow children to acclimate to the new school year. Calm & Alert uses mind, body, and breath to foster resiliency and self-regulation in students. This mindfulness-based intervention, which also incorporates yoga movements, aims to develop skills in self-awareness, self-regulation, safety, focus, attention, active listening, following directions, respect, and positive thinking. The program consists of six lessons lasting approximately 20-30 minutes, each conducted once a week over six consecutive weeks. An additional week will be included for the preschool students to familiarize them with the routine, songs, and visuals. It will be adapted to the age and needs of the students in each classroom. It may include materials provided by the primary researcher, such as a mini Hoberman sphere (breathing ball), chime, mind/body/breath icons, two small mason jars (one with mud and one with clear water), yoga mats for students, picture of the spine, pictures of feelings (happy, sad, angry, scared, surprised, disgusted), and an on/off switch. The protocol is multisensorial, with successive opportunities to practice the explicit concepts taught throughout the lessons. Each class has a similar structure of songs, breathing, warm-ups, yoga poses, mindful games, and rest involving meditation with child-friendly language.
What are the possible benefits and risks of participating?
There is no compensation and no guaranteed benefits from participating in this study. Mindfulness-based interventions have been researched in several studies. There are no known side effects of mindfulness-based interventions. There are potential risks of increased symptoms because mindfulness training can increase awareness of body sensations. Students will be doing gentle yoga with potential physical risks, such as pulled or strained muscles.
Where is the study run from?
Elizabethtown College (USA)
When is the study starting and how long is it expected to run for?
June 2023 to November 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Helen Russell, helen.c.c.russell@gmail.com
Contact information
Public, Scientific, Principal Investigator
430 Keating Rd
Warren
04864
United States of America
| Phone | +1 (0)2078444850 |
|---|---|
| helen.c.c.russell@gmail.com |
Study information
| Study design | Pretest-posttest control cluster randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participation information sheet |
| Scientific title | Efficacy of a mindfulness-based intervention in schools with a clinical population |
| Study objectives | This study aimed to measure the impact of the Calm & Alert mindfulness-based intervention when provided in the general education classroom once weekly for six weeks for 10-30 minutes per session. Specifically, studying the changes in executive function, including self-regulation, and prosocial behavior for students identified with at least one of the following: ASD, dyslexia, ADHD, other health impairment (OHI), anxiety, specific learning disability, dyslexia, or emotional disturbance. This pilot study will add to the growing body of research regarding a Mindfulness-Based Intervention (MBI)’s impact on vulnerable youth populations and potential best practices for implementation within the school setting. We hypothesized that the prosocial behavior and executive function would improve for those receiving the mindfulness-based intervention. |
| Ethics approval(s) |
Approved 09/08/2024, Elizabethtown College IRB (One Alpha Drive, Elizabethtown, 17022, United States of America; +1 (0)717 361 1366 Dept. Ext. 1174; panchikd@etown.edu), ref: 2086851-2 |
| Health condition(s) or problem(s) studied | Autism spectrum disorder, attention deficit hyperactivity disorder, other health impairment (IEP eligibility), specific learning disability (IEP eligibility criteria, dyslexia, emotional disturbance, anxiety |
| Intervention | Schools 1 & 2 were randomly assigned to the experimental and waitlist-control groups via hat draw. School 1 (n = 6) kindergarten and second-grade classrooms as well as School 2 (n = 13) third, fourth, and fifth classrooms, as well as a combined middle school study hall group, received the mindfulness intervention, Calm & Alert, for the initial 6 weeks. The Calm & Alert intervention will begin no earlier than the second week of school to allow children to acclimate to the new school year. Calm & Alert uses mind, body, and breath to foster resiliency and self-regulation in students. This mindfulness-based intervention, which also incorporates yoga movements, aims to develop skills in self-awareness, self-regulation, safety, focus, attention, active listening, following directions, respect, and positive thinking. The program consists of six lessons lasting approximately 20-30 minutes, each conducted once a week over six consecutive weeks. An additional week will be included for the preschool students to familiarize them with the routine, songs, and visuals. It will be adapted to the age and needs of the students in each classroom. It may include materials provided by the primary researcher, such as a mini Hoberman sphere (breathing ball), chime, mind/body/breath icons, two small mason jars (one with mud and one with clear water), yoga mats for students, picture of the spine, pictures of feelings (happy, sad, angry, scared, surprised, disgusted), and an on/off switch. The protocol is multisensorial, with successive opportunities to practice the explicit concepts taught throughout the lessons. Each class has a similar structure of songs, breathing, warm-ups, yoga poses, mindful games, and rest involving meditation with child-friendly language. |
| Intervention type | Behavioural |
| Primary outcome measure | Executive function measured using Behavior Rating Inventory of Executive Functioning-2nd edition (BRIEF-2) teacher report at baseline and 1-week post-intervention |
| Secondary outcome measures | 1. Prosocial behavior measured using the Strengths and Difficulties Questionnaire prosocial behavior subscale at baseline and 1-week post-intervention 2. Behavioral aspects of self-regulation measured using the Head-Toes-Knees-Shoulder Task at baseline and post-1 week (children in grades kindergarten to third grade only) |
| Overall study start date | 01/06/2023 |
| Completion date | 22/11/2023 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 34 |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. Aged 5 to 14 years 2. Having English fluency in spoken language 3. Having one of the following diagnoses or IEP/504 eligibility criteria ASD, ADHD, OHI, specific learning disability, dyslexia, emotional disturbance, anxiety diagnosis, or multiple disabilities or other health impairment due to at least one of the above (verified via educational records) |
| Key exclusion criteria | 1. Students whose first language was not English 2. Those who missed two or more sessions 3. Those who missed substantial portions of two or more sessions |
| Date of first enrolment | 14/09/2023 |
| Date of final enrolment | 22/09/2023 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Appleton
04862
United States of America
Lincolnville
04849
United States of America
Sponsor information
University/education
One Alpha Drive
Elizabethtown
17022
United States of America
| Phone | +1 (0)717 361 1366 |
|---|---|
| hamplek@etown.edu | |
| Website | https://www.etown.edu/index.aspx |
"ROR" |
https://ror.org/01y0mgq54 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 05/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and or analysed during the current study are available upon request by contacting Helen Russell (helen.c.c.russell@gmail.com). |
Editorial Notes
15/08/2024: Study's existence confirmed by the Elizabethtown College IRB.
