Clinical trial NCT04612647: Fit Families Program: Fundamental Motor Skill Intervention in Children With Autism Spectrum Disorders and Their Parents
Official title: Fit Families Program: Fundamental Motor Skill Intervention in Children With Autism Spectrum Disorders and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 41
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Gross Motor Development as Measured by TGMD-3
timeFrame: Baseline, 3 week post intervention (15 weeks), 3 months post intervention (24 weeks)
measure: Number of Participants Whose Perceptions Qualitatively Improve as measured via semi-structured interview
timeFrame: baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks), follow up (24 weeks)
measure: Fidelity of Intervention reported as Number of Parents who Implements the Intervention as Intended
timeFrame: up to 12 weeks
measure: Change in Social Communication Questionnaire (SCQ)
timeFrame: baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Luis A Columna, PhD
role: PRINCIPAL_INVESTIGATOR
References: