Active play in children with intellectual disabilities

ISRCTN ISRCTN10277566
DOI https://doi.org/10.1186/ISRCTN10277566
Submission date
05/08/2020
Registration date
14/08/2020
Last edited
08/02/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Children with intellectual disabilities participate in low levels of physical activity. Previous research has demonstrated that children with intellectual disabilities face many barriers to physical activity, such as not having the skills or opportunity to be active. Active play is an approach to physical activity that involves outdoor play and is not skill-dependant or reliant on equipment. Therefore, active play could be an effective way to overcome the barriers to physical activity experienced by children with intellectual disabilities. The aim of this study is to investigate the feasibility of a school-based active play intervention for children with intellectual disabilities.

Who can participate?
The intervention will be delivered in two additional support needs schools in Greater Glasgow, Scotland. A convenience sample will be recruited from the two participating additional support needs schools, with two classes selected from each school to recruit from. Children are eligible to participate if they have intellectual disabilities [measured by the Child and Adolescent Intellectual Disability Screening Scale (CAIDS-Q)], are aged 7-12 years and are independently ambulatory. Children with additional support needs who did not have intellectual disabilities were not eligible. All parents and participants were required to provide informed consent prior to participation.

What does the study involve?
The Go2Play Active Play intervention was developed in partnership between Agile CIC social enterprise (www.agilecic.com) and Inspiring Scotland (https://www.inspiringscotland.org.uk) to encourage children to play physically active games in an outdoor environment. Children participate in 17 weekly 1-hour active play sessions during school. Sessions are facilitated by local play charities and are designed to develop fundamental movement skills and increase activity levels, but also to be fun and inclusive to foster positive experiences and perceptions of physical activity. Sessions consist of 30 minutes structured play, with each session focussing on developing different fundamental movement skills, e.g. throwing and catching games to develop object control. The second half of the session focusses on free play where children are encouraged to interact and to create and play their own games, with the aim of developing social skills.

What are the possible benefits and risks of participating?
It is expected that children’s physical activity levels, fundamental movement skills, and social interactions will increase due to participating in this study, which could potentially benefit children’s health and development. The sessions are also designed to be fun and enjoyable for participants. There are no major anticipated risks, except for minor injuries or ailments that are associated with physical activity.

Where is the study run from?
This study is run from The University of Glasgow, Scotland (UK)

When is the study starting and how long is it expected to run for?
This study started on 03/01/2019 for 8 months.

Who is funding the study?
This study is funded by The Chief Scientist Office, Scotland (UK)

Who is the main contact?
Dr Arlene McGarty (Arlene.McGarty@glasgow.ac.uk)

Contact information

Dr Arlene McGarty
Scientific

College of Medical, Veterinary and Life Sciences
University of Glasgow.
Mental Health & Wellbeing
1st floor Admin Building
Gartnavel Royal Hospital
Glasgow
G12 0XH
United Kingdom

ORCiD logoORCID ID 0000-0003-4937-0574
Phone +44 (0)141 211 3902
Email Arlene.McGarty@glasgow.ac.uk

Study information

Study designMulticenter interventional single-arm feasibility trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)School
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleFeasibility of the Go2Play active play intervention for increasing physical and social development in children with intellectual disabilities
Study acronymAPID
Study objectivesIs it feasible to implement the Go2Play Active Play intervention in additional support needs schools for children with intellectual disabilities?
Ethics approval(s)Approved 14/09/2018, College of Medical Veterinary and Life Sciences ethics committee, University of Glasgow (120 University Place, Glasgow, G12 8TA, UK; no telephone number provided; mvls-ethics-admin@glasgow.ac.uk), ref: 200170188
Health condition(s) or problem(s) studiedPhysical and social development in children with intellectual disabilities
InterventionSingle-group 17-week intervention implemented in two additional support needs schools (n=21 participants). The intervention consists of a weekly 1-hour active play session incorporating 30 minutes of structured games and 30 minutes of free play. Outcome measures are measured at baseline and immediately post-intervention.
Intervention typeBehavioural
Primary outcome measureThe primary outcome is feasibility. Specifically:
1. Recruitment measured prior to the intervention commencing by a member of the research team based on the number of children recruited out of the total number of eligible children who received an information pack
2. Retention measured weekly based on if/how many participants drop out of the trial. This is measured by the researcher team and based on feedback from teachers
3. Intervention adherence is measured as:
3.1. Attendance at each intervention activity session measured a member of the research team or teacher
3.2. Percentage of intervention session spent active at a moderate to vigorous intensity, measured using the ActiGraph GT3X+ accelerometer during 4 sample activity sessions at each school
4. Acceptability of different outcome measures:
4.1. School-based physical activity and sedentary behaviour are measured at baseline and post-intervention using the ActiGraph GT3X+ accelerometer, with feasibility assessed on the number of participants who meet the required wear time of four out of the five measurement days for at least 3 hours per day (which represents approximately 50% of the school day)
4.2. Fundamental movement skills were assessed at baseline and post-intervention using the Test of Gross Motor Development-2 (TGMD-2), with the percentage of participants completing this test, as well as reasons for non-compliance, recorded to assess feasibility
4.3. Social interactions are measured during the first and last intervention sessions using the Playground Observation of Peer Engagement (POPE) tool. Feasibility was assessed on whether this direct observation methodology and use of the POPE tool enabled all relevant social interactions to be recorded
4.4. Staff feedback relating to perceptions of feasibility, benefits/limitations, and effectiveness of delivery was collected via questionnaire from teachers (n = 3), whose students were involved in the intervention, and the lead facilitator of the intervention (n = 1).
Secondary outcome measures1. School-based physical activity and sedentary behaviour are measured at baseline and post-intervention using the ActiGraph GT3X+ accelerometer, with potential intervention effects examined using paired samples t-tests
2. Fundamental movement skills were assessed at baseline and post-intervention using the Test of Gross Motor Development-2 (TGMD-2), with potential intervention effects examined using paired samples t-tests
3. Social interactions are measured during the first and last intervention sessions using the Playground Observation of Peer Engagement (POPE) tool, with potential intervention effects examined using paired samples t-tests
Overall study start date14/09/2018
Completion date30/08/2019

Eligibility

Participant type(s)Other
Age groupChild
Lower age limit7 Years
Upper age limit12 Years
SexBoth
Target number of participants21
Total final enrolment21
Key inclusion criteria1. Have intellectual disabilities [measured by the Child and Adolescent Intellectual Disability Screening Scale (CAIDS-Q)]
2. Aged 7-12 years
3. Are independently ambulatory
Key exclusion criteriaChildren with additional support needs who do not have intellectual disabilities
Date of first enrolment03/01/2019
Date of final enrolment10/01/2019

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

University of Glasgow
Mental Health & Wellbeing
1st floor Admin Building
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Sponsor information

University of Glasgow
University/education

Mental Health & Wellbeing
1st floor Admin Building
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
Scotland
United Kingdom

Phone +44 (0)141 330 4539
Email Debra.Stuart@glasgow.ac.uk
Website http://www.gla.ac.uk/
ROR logo "ROR" https://ror.org/00vtgdb53

Funders

Funder type

Government

Chief Scientist Office
Government organisation / Local government
Alternative name(s)
CSO
Location
United Kingdom

Results and Publications

Intention to publish date01/09/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 05/02/2021 08/02/2021 Yes No

Editorial Notes

08/02/2021: Publication reference added.
14/08/2020: Internal review.
10/08/2020: Trial’s existence confirmed by University of Glasgow