Feasibility and Acceptability of a Co-produced Intervention to Improve Physical Activity and Moto… (NCT07456514) | Clinical Trial Compass
CompletedNot Applicable
Feasibility and Acceptability of a Co-produced Intervention to Improve Physical Activity and Motor Competence Amongst Children With Intellectual Disabilities and/or Autism Spectrum Disorder: Movement Matters
United Kingdom43 participantsStarted 2022-03-16
Plain-language summary
The goal of this observational study is to find out whether an intervention designed to improve physical activity levels and movement skills is practical and acceptable for children aged 7-11 years with intellectual disabilities and/or autism spectrum disorder.
The intervention will be designed with input from people with lived experience, including professionals working in schools, physical education, sport, health services, and charities, as well as parents and families. The study will explore whether this type of intervention can be realistically delivered in special educational needs schools as part of their usual day-to-day activities.
The main question the study aims to answer is:
• Is an intervention to improve physical activity and motor skills feasible and acceptable for special educational needs schools?
Participating schools will implement the intervention for six weeks. Several outcomes related to feasibility and acceptability will be measured to understand how well the intervention works in a school setting.
Who can participate
Age range
7 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged 7 to 11 years
* Special Educational Needs and Disability (SEND) statement indicating a primary diagnosis of intellectual disability and/or Autism Spectrum Disorder
* Independently ambulatory (able to walk without physical assistance) to allow completion of the motor skill testing protocol
Exclusion Criteria:
* Children younger than 7 years or older than 11 years
* No Special Educational Needs and Disability (SEND) statement indicating a primary diagnosis of intellectual disability or Autism Spectrum Disorder
* Not independently ambulatory and therefore unable to complete the motor skill testing protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
School Eligibility Rate (Screening Log Assessment)
Timeframe: Baseline
2
Participant Recruitment Rate (Consent Form Return Log)
Timeframe: Baseline
3
Completion Rate of Motor Competence (BOT-2), Physical Activity (Accelerometry), and Anthropometric (Stature and Body Mass) Measures
Timeframe: Baseline to the end of intervention at 6 weeks
4
Loss to Follow-Up Rate (Child-Level Outcome Assessment Completion Log)
Timeframe: Baseline to the end of intervention at 6 weeks