Fit Families Multisite

NCT05451459 | Completed

• 3 other identifiers: 2022-0165A1760003/15/2022
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is twofold. First, the investigator wants to identify the effect of a 12-week online fundamental motor skills (FMS) (e.g., throwing, catching, running) intervention on active participation in physical recreation activities as well as a variety of other factors(parental stress, parental self-efficacy, and children's adaptive skills). Second, the investigator also wants to identify patterns, benefits, constraints, and strategies to active participation in physical recreation activities among families of children with developmental disabilities such as autism, down syndrome, etc (post-program) via focus groups interviews (via zoom) with parents. Participants will be randomly assigned to one of two protocols: 1) Intervention group and 2) wait-listed home-based group. Participants in both groups will receive an activity booklet (in the form of an App) and physical education-related activity items (e.g., ball, hoop). The investigator hypothesizes that both the intervention group will improve in all measures from pre to post compared to the wait-list control group. The study team wants to determine if the differences in the intervention group differ significantly or are equitable in terms of gains in all areas.

Conditions

Developmental Disability; Intellectual Disability

Outcome Measures

Primary Outcomes (4)

• 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 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. The ratings for each skill are converted into a score from 1 to 19 with a higher score indicative of higher adaptive behavior skills.

  Baseline, 3 week post intervention (15 weeks)

• DCDQ: Developmental Coordination Disorder Questionnaire

  The Developmental Coordination Questionnaire (DCDQ) is a parent report measure developed to assist in the identification of Developmental Coordination Disorder (DCD) in children. Parents are asked to compare their child's motor performance to that of his/her peers using a 5 point Likert scale. Most of the motor skills that this questionnaire asks about are things that a child does with his or her hands, or while moving. The scale ranges from 1 (not at all like your child) to 5 (extremely like your child).

  Baseline, 3 week post intervention (15 weeks)

• TOPSE: Tool to measure Parenting Self-Efficacy

  TOPSE: Tool to measure Parenting Self-Efficacy is used to measure play and enjoyment. The scale ranges from 0 (completely disagree) to 10 (completely agree). On a ten-point response scale, raters indicate how much they agree with each statement

  Baseline, 3 week post intervention (15 weeks)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will be offered four one-day group workshops (2-3 hours each) covering topics of 1) Sensory Integration, 2) Communication, 3) Physical activity, and 4) Sports. The workshops will be offered online via Zoom and will be video recorded. The intervention group will also receive information (activity booklets via the Fit Families App) and physical education (physical activity)-related equipment, which will be mailed to them. At the end of the workshop parents will be instructed to practice the skills they learned with their child for the next 3 weeks (for at least 3 hrs per week).

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

Wait-list home-based group

OTHER

The wait-list home-based group will serve as the control group (during intervention). This group will be instructed to continue their typical routines and activities for the duration of the 12-week intervention. At the end of the 12 weeks, they will be asked to complete the post-test surveys (same as questionnaires completed prior to randomization). Their participation in the research will be complete at this time. However, because the intervention has been shown to potentially benefit families, immediately following the post-test, participants in the wait-list home-based group will be offered the chance to complete the home-based intervention program (e.g., receiving the same intervention protocol and materials (physical education equipment and lesson plans/workbook) as described for the intervention group). No data will be collected for research from them during this time.

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

Interventions

12-week FMS Intervention OTHER

4 virtual workshops (2-3 hours each) covering topics of 1) Sensory Integration, 2) Communication, 3) Physical activity, and 4) Sports (during intervention)

Intervention Group

Physical Activities & Activity Booklets (via FitFamilies app) BEHAVIORAL

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

Intervention Group; Wait-list home-based group

Eligibility Criteria

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

You may qualify if:

• Parents (one per family) of children with developmental and intellectual disabilities ages 4 to 11 will be included. Because this study is focused on families (parents) of children with developmental and intellectual disabilities, in order to participate, developmental and intellectual disabilities must be the primary disability. Children could have other disabilities besides developmental and intellectual disabilities, but developmental and intellectual disabilities must be their primary disability. Diagnostic severity of developmental and intellectual disabilities will not be a factor in recruitment. Recruitment will be based on diagnosis and the ability 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. For adults (parents of children with developmental and intellectual disabilities) there will not be an age restriction. In addition, parents should be ambulatory and not have any restrictions to do physical activity. Lastly, because this study is focused on the States of Wisconsin and New York, participants need to reside either in the State of Wisconsin or in the State of New York, particularly upstate New York.
• Note: While the children will be benefiting from this program, participants in this study will be the parents

You may not qualify if:

• Children with developmental and intellectual disabilities younger than 4 years old and older than 11 years old will be excluded from this research study. Because this study is focused on families (parents) of children with developmental and intellectual disabilities, parents of children with other primary disabilities, or parents who do not have children with developmental and intellectual disabilities 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. Participants who are not residents of the States of New York or Wisconsin will not be able to participate in this study.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Syracuse University: collaborator
• University of Northern Iowa: collaborator

Study Sites (1)

University of Wisconsin- Madison

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Developmental Disabilities; Intellectual Disability

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Luis 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: July 6, 2022
• First Posted: July 11, 2022
• Study Start: April 20, 2022
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

US (1)