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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02940899
Other study ID # 28491
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date December 30, 2018

Study information

Verified date April 2019
Source Syracuse University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 5 Years to 11 Years
Eligibility 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 Design


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.

Locations

Country Name City State
United States Syracuse University Syracuse New York

Sponsors (2)

Lead Sponsor Collaborator
Syracuse University Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Physical Activity Experiences To asses parents' experiences regarding physical activity. This will be measured using qualitative parent interviews. Two years
Secondary Physical Activity Experiences To asses parents' experiences regarding physical activity. This will be measured using quantitative parent reports. Two years
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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