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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612647
• Other study ID #: 2019-1256
• Secondary ID: A176000EDUC/KINE
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: May 24, 2020

Study information

• Verified date: October 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 24, 2020
• Est. primary completion date: May 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• 12-week FMS Intervention
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)

Behavioral:
• Physical Activities & Activity Booklets
expected to engage in physical activity at least 3 hours per week

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gross Motor Development as Measured by TGMD-3	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.	Baseline, 3 week post intervention (15 weeks), 3 months post intervention (24 weeks)
Primary	Number of Participants Whose Perceptions Qualitatively Improve as measured via semi-structured interview	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.	baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks), follow up (24 weeks)
Primary	Fidelity of Intervention reported as Number of Parents who Implements the Intervention as Intended	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.	up to 12 weeks
Primary	Change in Social Communication Questionnaire (SCQ)	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.	baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks)