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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12-week FMS Intervention
Physical Activities & Activity Booklets
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder

Eligibility Criteria

4 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Workshop group

Home-based group

wait-listed home-based group

Arm Description

Participants in the workshop group will be offered four one-day workshops (3-hours each) covering topics of 1) Sensory Integration, 2) Communication, 3) Aquatic Opportunities, and 4) Physical activity and Sports (during intervention)-[Parents and Children-Workshop Group]. In addition to the workshops, this group and the home-based group will receive information (activity booklets) and physical education (physical activity)-related equipment.

Participants in the home-based group will not participate in the four half-day workshops, but they will receive the same information (activity booklets) and physical activity equipment as the workshop group (during intervention)-[Parents and Children-Home Group].

Wait-list home-based group will serve as the control group (during intervention)-[Parents and Children-Control Group]. This group will be instructed to continue their typical routines and activities for the duration of the intervention. They will be asked to attend the pre and posttest, as well as a follow up three weeks and 3 months after the completion of the 12-week period. Immediately following the follow-up test (3 months after the intervention), participants in the wait-list home-based group will be offered the home-based program (e.g., receiving the same intervention protocol and materials (physical education equipment and lesson plans/workbook) following all procedures as described for that group previously.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2020
Last Updated
October 28, 2020
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT04612647
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
May 24, 2020 (Actual)
Study Completion Date
May 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Workshop group
Arm Type
Experimental
Arm Description
Participants in the workshop group will be offered four one-day workshops (3-hours each) covering topics of 1) Sensory Integration, 2) Communication, 3) Aquatic Opportunities, and 4) Physical activity and Sports (during intervention)-[Parents and Children-Workshop Group]. In addition to the workshops, this group and the home-based group will receive information (activity booklets) and physical education (physical activity)-related equipment.
Arm Title
Home-based group
Arm Type
Experimental
Arm Description
Participants in the home-based group will not participate in the four half-day workshops, but they will receive the same information (activity booklets) and physical activity equipment as the workshop group (during intervention)-[Parents and Children-Home Group].
Arm Title
wait-listed home-based group
Arm Type
No Intervention
Arm Description
Wait-list home-based group will serve as the control group (during intervention)-[Parents and Children-Control Group]. This group will be instructed to continue their typical routines and activities for the duration of the intervention. They will be asked to attend the pre and posttest, as well as a follow up three weeks and 3 months after the completion of the 12-week period. Immediately following the follow-up test (3 months after the intervention), participants in the wait-list home-based group will be offered the home-based program (e.g., receiving the same intervention protocol and materials (physical education equipment and lesson plans/workbook) following all procedures as described for that group previously.
Intervention Type
Other
Intervention Name(s)
12-week FMS Intervention
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Physical Activities & Activity Booklets
Intervention Description
expected to engage in physical activity at least 3 hours per week
Primary Outcome Measure Information:
Title
Change in Gross Motor Development as Measured by TGMD-3
Description
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.
Time Frame
Baseline, 3 week post intervention (15 weeks), 3 months post intervention (24 weeks)
Title
Number of Participants Whose Perceptions Qualitatively Improve as measured via semi-structured interview
Description
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.
Time Frame
baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks), follow up (24 weeks)
Title
Fidelity of Intervention reported as Number of Parents who Implements the Intervention as Intended
Description
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.
Time Frame
up to 12 weeks
Title
Change in Social Communication Questionnaire (SCQ)
Description
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.
Time Frame
baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis A Columna, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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