- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07456514
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 (MM)
Movement Matters: Feasibility of a Pilot Intervention to Improve Physical Activity and Motor Competence Amongst Children With Intellectual Disabilities
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Liverpool, United Kingdom
- Liverpool John Moores University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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School Eligibility Rate (Screening Log Assessment)
Time Frame: Baseline
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Percentage of all SEND schools in the target area that meet predefined inclusion criteria, assessed using a school eligibility screening log.
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Baseline
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Participant Recruitment Rate (Consent Form Return Log)
Time Frame: Baseline
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Percentage of eligible children who return completed parent/carer consent forms, recorded using a consent tracking log.
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Baseline
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Completion Rate of Motor Competence (BOT-2), Physical Activity (Accelerometry), and Anthropometric (Stature and Body Mass) Measures
Time Frame: Baseline to the end of intervention at 6 weeks
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Percentage of recruited participants who complete all baseline and follow-up assessments using the Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2), Accelerometer (ActiGraph GT3X worn on the non dominant wrist for 7-days), stature measured to the nearest 0.1cm and body mass to the nearest 0.1 kg.
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Baseline to the end of intervention at 6 weeks
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Loss to Follow-Up Rate (Child-Level Outcome Assessment Completion Log)
Time Frame: Baseline to the end of intervention at 6 weeks
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Percentage of recruited participants who do not complete any follow-up assessments, recorded using the study assessment tracking log.
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Baseline to the end of intervention at 6 weeks
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Intervention Dose Delivered (Teacher Implementation Log)
Time Frame: Baseline to the end of intervention at 6 weeks
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Adherence to the Movement Matters intervention measured using a fidelity checklist completed by teachers
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Baseline to the end of intervention at 6 weeks
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Teacher and Coach Acceptability (Post-Training Acceptability Questionnaire)
Time Frame: Baseline to the end of intervention at 6 weeks
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Study-specific post-training acceptability questionnaire consisting of 5-point Likert scale items assessing satisfaction, perceived usefulness, and appropriateness of the training.
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Baseline to the end of intervention at 6 weeks
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Intervention Acceptability (Teacher Post-Intervention Acceptability Questionnaire)
Time Frame: Baseline to the end of intervention at 6 weeks
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Teacher satisfaction with the intervention measured using a structured post-intervention acceptability questionnaire including 5-point Likert scale items assessing overall satisfaction (not at all satisfied to very satisfied), perceived ease of use, and perceived burden (strongly disagree to strongly agree), as well as open-ended qualitative feedback questions.
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Baseline to the end of intervention at 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Physical Activity Levels (Measured by accelerometry)
Time Frame: Baseline to the end of intervention at 6 weeks
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Change in physical activity levels from baseline to 6 weeks measured using ActiGraph GT3X accelerometer worn on the non-dominant wrist at baseline and follow-up for 7-days.
Physical activity will be quantified as average minutes of moderate-to-vigorous physical activity per day.
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Baseline to the end of intervention at 6 weeks
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Change in Motor Competence (Measured by BOT-2)
Time Frame: Baseline to the end of intervention at 6 weeks
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Change in motor competence from baseline to 6 weeks measured using the Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2).
Motor competence is scored according to the BOT-2 manual, first receiving a raw score then converted to point score.
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Baseline to the end of intervention at 6 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Autism Spectrum Disorder
- Intellectual Disability
- Motor Activity
Other Study ID Numbers
- TRUST/VC/AC/SG/5742-8882
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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