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Clinical Trials/NCT04612647
NCT04612647
Completed
Not Applicable

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

University of Wisconsin, Madison1 site in 1 country41 target enrollmentJanuary 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University of Wisconsin, Madison
Enrollment
41
Locations
1
Primary Endpoint
Change in Gross Motor Development as Measured by TGMD-3
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
January 2, 2020
End Date
May 24, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

Study Sites (1)

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