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Completed

NCT Number: NCT04612647

Fit Families Program: Fundamental Motor Skill Intervention in Children With Autism Spectrum Disorders and Their Parents

The investigators aim to identify the effect of a 12-week fundamental motor skills (FMS) (e.g., throwing, catching, running) intervention on the active participation in physical recreation activities and a variety of other factors (child behaviors, communication, and adaptive skills) and to identify patterns, benefits, constraints, and strategies to active participation in physical recreation activities among families of children with autism spectrum disorders (ASD) (pre-post) through in-person or via phone interviews with parents and children with ASD.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53706, United States

About this study

Participants will be randomly assigned to one of three protocols: 1) Workshop group, 2) Home-based group, and 3) wait-listed home-based group. Participants in all groups will receive an activity booklet and physical education-related activity items (e.g., ball, hoop). The hypothesis is that both the workshop and home-based groups will improve in all measures from pre to post compared to the wait-list control group. The investigators want to determine if the differences in the workshop and home-based groups differ significantly or are equitable in terms of gains in all areas.

Note: Due to COVID-19 for the post-test, instead of parents attending the UW-Facilities, they will be asked to videotape themselves and their children while performing the test of gross motor development (TGMD) activities. For the follow-up test (Fall 2020) we will expect to conduct these in person. However, if the situation due to COVID-19 remains the same, the investigators will ask families to follow the same procedures (videotape themselves and their children).

Who can participate

Healthy volunteers accepted: Yes

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

Parents (one per family) and children with ASD ages 4 to 11 will be included (recruited as a dyad).

Inclusion criteria

  • ASD must be the primary disability of the child
  • Children will be considered to have ASD if they score above the clinical cutoff or 15 on both the lifetime and current versions of the SCQ. Diagnostic severity of ASD will not be a factor in recruitment.
  • Children must be able to participate in the program activities.
  • Children must be ambulatory and able to follow verbal or picture directions with support
  • Children with significant communication needs will still be considered for the study
  • No age restriction for adults (parents of children with ASD)
  • Parents should be ambulatory and not have any restriction to do physical activity

Exclusion criteria

  • Parents of children with other primary disabilities, or parents who do not have children with ASD will be excluded.
  • Participants cannot exhibit aggressive behavior
  • Children who are non-ambulatory, or participants (children) with significant behavioral or sensory impairments will also be excluded based on application information, including existing behavior intervention plans and existing school information

Treatment and study plan

12-week FMS Intervention

Other

4 sessions, no more than 3 hours per session covering 1) Sensory Integration, 2) Communication, 3) Aquatic Opportunities, and 4) Physical activity and Sports (during intervention)

Physical Activities & Activity Booklets

Behavioral

expected to engage in physical activity at least 3 hours per week

Primary outcomes

  1. Change in Gross Motor Development as Measured by TGMD-3

    Time frame: Baseline, 3 week post intervention (15 weeks), 3 months post intervention (24 weeks)

    The Test of Gross Motor Development - second edition (TGMD-3) is a measure of fundamental motor skills. The total possible range of scores is 47-158, where higher scores are indicative of improved gross motor development.

  2. Number of Participants Whose Perceptions Qualitatively Improve as measured via semi-structured interview

    Time frame: baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks), follow up (24 weeks)

    Children will participate in one-on-one semi-structured interviews with the research team to explore their perception regarding communication strategies (between parent and child), patterns of physical recreation, perceived benefits, and constraints.

  3. Fidelity of Intervention reported as Number of Parents who Implements the Intervention as Intended

    Time frame: up to 12 weeks

    Fidelity checklists will be used to determine the fidelity of the intervention. Parents will be asked to email a video of 1-2 lessons per week along with a completed task analysis checklist. Parents will be asked to confirm whether or not each task was completed on the checklist. The research team will complete the same form while viewing the video to ensure whether the parent knows and is implementing the steps intended and if there are fidelity differences between the workshop and home-based group.

  4. Change in Social Communication Questionnaire (SCQ)

    Time frame: baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks)

    The SCQ is a 40-item survey where each question is a 'yes' or 'no' answer. The total possible range of scores is 0-39 (verbal children) or 0-33 (non-verbal children) with higher scores indicative of greater frequency of symptoms.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 3, 2020
Registry last updated
Nov 3, 2020

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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