Fit Families Program for Families of Children With Autism Spectrum Disorder

NCT05159102 | Completed

• 3 other identifiers: 2019-1256 New CohortA176000EDUC/KINESIOLOGY/KINESIO
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is twofold. First, 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 as well as a variety of other factors (child behaviors, communication, and adaptive skills). Second, 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. 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 (in the form of an App) and physical education-related activity items (e.g., ball, hoop). The investigators hypothesize 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (8)

• 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)

• Change in qualitative perceptions of the participants 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)

• 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)

• Change in Parenting Stress Index (PSI)- Short form

  The Parenting Stress Index (PSI)- short form is used to measure the relative stress in the parent-child relationship. Parents complete the PSI Short Form test sheet including basic demographic information on the top of the questionnaire first. For most items, parents should respond by circling SA (strongly agree), A (agree), NS (not sure), D (disagree), SD (strongly disagree). Higher raw scores indicate higher levels of stress. Percentile scores that fall between 15 and 80 are considered typical.

  Baseline, 3 week post intervention (15 weeks)

• Change in Sensory Profile (Dunn 1999)

  The Sensory Profile (Dunn, 1999) is designed to function as a part of a broader assessment of a child's functioning, which may include other observations, history, and diagnostic tests. The parent/caregiver reports the frequency of the behaviors in question, utilizing a Likert scale of always, frequently, occasionally, sometimes, and never. The Sensory Profile consists of 125 items grouped into three main sections: sensory processing, modulation, and behavioral and emotional responses.

  Baseline, 3 weeks post intervention (15 weeks)

• Change in the Behavioral Assessment System for Children (BASC-III) (Reynolds & Kamphaus, 2015)

  To evaluate social behavior, problem behavior, and emotionality of the child. The narrative and scale classifications in this report are based on T scores obtained using norms. Scale scores in the Clinically Significant range suggest a high level of maladjustment. Scores in the At-Risk range may identify a significant problem that may not be severe enough to require formal treatment or may identify the potential of developing a problem that needs careful monitoring.

  Baseline, 3 week post intervention (15 weeks)

• Change in Adaptive Behavior Assessment System (ABAS-3)

  To evaluate adaptive behavior skills of the child. The ABAS-3 covers three broad adaptive domains: Conceptual, Social, and Practical. Within these domains, it assesses 11 adaptive skill areas (each form assesses 9 or 10 skill areas based on age range). Items focus on practical, everyday activities required to function, meet environmental demands, care for oneself, and interact with others effectively and independently. On a four-point response scale, raters indicate whether the individual can perform each activity, and if so, how frequently they perform it when needed.

  Baseline, 3 week post intervention (15 weeks)

• Change in Physical Activity Questionnaire

  Parents will be asked to complete a weekly Qualtrics survey inquiring about the type of activities and time they spend participating in those activities. In this survey, parents will comment on the FMS strategies they used or did not use during the week(s).

  Baseline, weekly throughout the 12 weeks, post intervention (15 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) Physical activity, and 4) Sports (during intervention)-\[Parents and Children-Workshop Group\]. These workshops will be offered in person. In addition to the workshops, this group and the home-based group will receive information (activity booklets via the Fit Families App) and physical education (physical activity)-related equipment.

Other: 12-week FMS Intervention; Behavioral: Physical Activities & Activity Booklets (via FitFamilies app)

Home-based group

EXPERIMENTAL

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

Other: 12-week FMS Intervention; Behavioral: Physical Activities & Activity Booklets (via FitFamilies app)

wait-listed home-based group

OTHER

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 after the completion of the 12-week period. Immediately following the follow-up test, 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.

Behavioral: Physical Activities & Activity Booklets (via FitFamilies app)

Interventions

12-week FMS Intervention OTHER

4 sessions, no more than 3 hours per session covering 1) Sensory Integration, 2) Communication, 3) Physical activity, and 4) and Sports (during intervention)

Home-based group; Workshop group

Physical Activities & Activity Booklets (via FitFamilies app) BEHAVIORAL

expected to engage in physical activity at least 3 hours per week, parent workshops provide them with resources to engage in Physical activity

Also known as: Parent workshops

Home-based group; Workshop group; wait-listed home-based 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

Related Publications (1)

• Prieto LA, Meera B, Barry A, Swarup G, Asmus J, Ku B, Roth K, Foley JT, Columna L. A randomized parent-mediated physical activity intervention for autistic children. Autism Res. 2023 Jul;16(7):1450-1461. doi: 10.1002/aur.2969. Epub 2023 Jun 26.

  PMID: 37357811 DERIVED

Related Links

• Initial Fit Families Program Study

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 11, 2021
• First Posted: December 15, 2021
• Study Start: August 6, 2021
• Primary Completion: January 8, 2022
• Study Completion: January 8, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

US (1)