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Completed

NCT Number: 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

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.

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Key information

Conditions

Physical Activity Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Intellectual Disability Mental Disorders Motor Activity Motor Skills Development Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Liverpool John Moores University

Liverpool, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Movement Matters

Other

A multi-component intervention comprising of Teacher/Coach Training, School-Based Physical Activity, Family Co-Participation in PA, Parent Education, School Multi-Skill Event, Use of Role Models.

Primary outcomes

  1. School Eligibility Rate (Screening Log Assessment)

    Time frame: Baseline

    Percentage of all SEND schools in the target area that meet predefined inclusion criteria, assessed using a school eligibility screening log.

  2. Participant Recruitment Rate (Consent Form Return Log)

    Time frame: Baseline

    Percentage of eligible children who return completed parent/carer consent forms, recorded using a consent tracking log.

  3. 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

    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.

  4. Loss to Follow-Up Rate (Child-Level Outcome Assessment Completion Log)

    Time frame: Baseline to the end of intervention at 6 weeks

    Percentage of recruited participants who do not complete any follow-up assessments, recorded using the study assessment tracking log.

  5. Intervention Dose Delivered (Teacher Implementation Log)

    Time frame: Baseline to the end of intervention at 6 weeks

    Adherence to the Movement Matters intervention measured using a fidelity checklist completed by teachers

  6. Teacher and Coach Acceptability (Post-Training Acceptability Questionnaire)

    Time frame: Baseline to the end of intervention at 6 weeks

    Study-specific post-training acceptability questionnaire consisting of 5-point Likert scale items assessing satisfaction, perceived usefulness, and appropriateness of the training.

  7. Intervention Acceptability (Teacher Post-Intervention Acceptability Questionnaire)

    Time frame: Baseline to the end of intervention at 6 weeks

    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.

Secondary outcomes

  1. Change in Physical Activity Levels (Measured by accelerometry)

    Time frame: Baseline to the end of intervention at 6 weeks

    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.

  2. Change in Motor Competence (Measured by BOT-2)

    Time frame: Baseline to the end of intervention at 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Registry information

Official study title

Movement Matters: Feasibility of a Pilot Intervention to Improve Physical Activity and Motor Competence Amongst Children With Intellectual Disabilities

Acronym: MM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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