Syracuse University Fit Families Program: Autism (SUFFP)

Fit Families Program for Children With Autism

Syracuse University Fit Families is designed to increase the activity level and frequency of the children through modified activities using adapted equipment and, importantly, to increase the families' comfort level in having their children participate in a variety of physical activities, including team and individual sports.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorders
• Intervention / Treatment: Other: Intervention: Syracuse University Fir Families Program (SUFFP)

Detailed Description

Syracuse University Fit Families is designed to increase the activity level and frequency of the children through modified activities using adapted equipment and, importantly, to increase the families' comfort level in having the children participate in a variety of physical activities, including team and individual sports. By increasing physical activity levels, investigators can reduce sedentary behaviors that lead to conditions such as obesity and cardiovascular diseases. The investigators will provide a series of workshops that will also teach children and families how to access nearby facilities and modify familiar activities, resulting in health benefits for all. Children, and parents will be involved in developmentally designed, land-based and aquatic physical activities. Parents will be engage in vibrant discussions with professionals and other parents who share similar experiences.

Services provided through the Syracuse University Fit families program are designed to improve the emotional, social and physical well-being of the participants. This program will include 1) educational seminars for parents on topics that improve awareness, advocacy, and access to community services; 2) inclusive games and modified sports for children, and parents to improve self-awareness, social interactions, and physical fitness; 3) individual consultation with physical activity professionals to address children's and families' social and recreational needs; and 4) opportunities for social networking for families participating in the program, including mentoring of youth by adapted sports athletes.

The project is proposed to run from November 2015 through June 2017. Five one-day workshops will be offered annually to participants covering topics of: 1) sensory integration, 2) communication, 3) motor development and physical activity; 4) aquatic; and 5) sport opportunities (individual and team sport). As part of program evaluation, the investigators will be conducting measurements on parents (e.g., quality of life, physical activity levels) and children (e.g., social communication, sensory behaviors, quality of life, physical activity levels, blood pressure). The investigators will assess these in a pre-post fashion in order to determine whether the program has led to generalized improvements in these areas. The testing procedure requires minimal invasion and it is not overwhelming for the participants. The investigators have implemented similar procedures in previous programs.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13244
      • Syracuse University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of autism spectrum disorders
• Children with autism spectrum disorders 5-11 years old
• Must be ambulatory
• Must be able to follow verbal or picture directions with support.
• Must not exhibit aggressive behavior.

Exclusion Criteria:

• Children with autism spectrum disorders younger than 4-11 years old
• Children with autism spectrum disorders older than 11 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention: Syracuse University Fir Families Program (SUFFP); SUFFP is a randomized control trial comparing two groups of families of children with autism spectrum disorders. 20 families participated in the intervention program	Other: Intervention: Syracuse University Fir Families Program (SUFFP); The SUFFP (Syracuse University Fit Families Program) is a randomized clinical trial, were 40 children with autism spectrum disorders ages 5-11 and at least one parent were randomly assigned to one of two group-based conditions; interventions or a control wait list group.
Active Comparator: Control: Syracuse University Fir Families Program (SUFFP); 20 families served as a wait-list control group. The control group will fill out the same pre and post measures as the intervention families (membership in the control vs. intervention group will be selected semi-randomly such that the average age of each of the two groups is equal), which will allow us to tease apart the effects of development vs. those related to the intervention.	Other: Intervention: Syracuse University Fir Families Program (SUFFP); The SUFFP (Syracuse University Fit Families Program) is a randomized clinical trial, were 40 children with autism spectrum disorders ages 5-11 and at least one parent were randomly assigned to one of two group-based conditions; interventions or a control wait list group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	To assess physical activity levels among families of children with autism spectrum disorders. This outcome will be measured by counting steps by day using accelerometry.	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor skills of Parents and Children	To asses the motor skills of parents and children with autism spectrum disorders. This outcome will be measured using the Test of Gross Motor Development 2.	Two years
Adaptive behavior	To asses adaptive behavior of children with autism spectrum disorders. This outcome will be measured using the Vinland Adaptive Behavior Scales.	Two years
Reported Behavior Problems	To asses is there a change in parents' reported behavioral problems of children with autism spectrum disorders as a result of the intervention. This outcome will be measured using the Behavior Assessment System for Children (BASC 2).	Two years
Sensory Processing	To asses is there a change in in sensory processing as a result of the intervention. This outcome will be measured using the Sensory Profile (Dunn 1999).	Two years
Quality of Life of Parents of Children with Autism Spectrum Disorders	To asses the quality of life children with autism spectrum disorders. This outcome will be measured using self reports.	Two years
Physical Activity Experiences	To asses parents' experiences regarding physical activity. This will be measured using qualitative parent interviews.	Two years
Physical Activity Experiences	To asses parents' experiences regarding physical activity. This will be measured using quantitative parent reports.	Two years
Cardiovascular Health	Examine the effect of Fit Families on arterial stiffness in children with ASD. This will be derived from brachial pressure waveforms obtained via an oscillometric cuff.	Two years
Cardiovascular Health	Examine the effect of Fit Families on central blood pressure in children with ASD. This will be derived from brachial pressure waveforms obtained via an oscillometric cuff.	Two years
Cardiovascular Health	Examine the effect of Fit Families on arterial stiffness in the parents of children with ASD. This will be derived from brachial pressure waveforms obtained via an oscillometric cuff.	Two years
Cardiovascular Health	Examine the effect of Fit Families on central blood pressure in the parents of children with ASD. This will be derived from brachial pressure waveforms obtained via an oscillometric cuff.	Two years

Collaborators and Investigators

• Sponsor: Syracuse University
• Collaborators: Texas Woman's University
• Investigators: Principal Investigator: Luis Columna, Ph.D, Syracuse University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: June 3, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 28491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No