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

NCT04612647 | Completed

• 3 other identifiers: 2019-1256A176000EDUC/KINESIOLOGY/KINESIO
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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

• 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)

Study Arms (3)

Workshop group

EXPERIMENTAL

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.

Other: 12-week FMS Intervention; Behavioral: Physical Activities & Activity Booklets

Home-based group

EXPERIMENTAL

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)-\[Parents and Children-Home Group\].

Behavioral: Physical Activities & Activity Booklets

wait-listed home-based group

NO INTERVENTION

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.

Interventions

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)

Workshop group

Physical Activities & Activity Booklets BEHAVIORAL

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

Home-based group; Workshop group

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luis A Columna, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: January 2, 2020
• Primary Completion: May 24, 2020
• Study Completion: May 24, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)