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Syracuse University Fit Families Program: Autism (SUFFP)

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention: Syracuse University Fir Families Program (SUFFP)
Sponsored by
Syracuse University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorders

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Syracuse University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention: Syracuse University Fir Families Program (SUFFP)

Control: Syracuse University Fir Families Program (SUFFP)

Arm Description

SUFFP is a randomized control trial comparing two groups of families of children with autism spectrum disorders. 20 families participated in the intervention program

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Adaptive behavior
To asses adaptive behavior of children with autism spectrum disorders. This outcome will be measured using the Vinland Adaptive Behavior Scales.
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).
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).
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.
Physical Activity Experiences
To asses parents' experiences regarding physical activity. This will be measured using qualitative parent interviews.
Physical Activity Experiences
To asses parents' experiences regarding physical activity. This will be measured using quantitative parent reports.
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.
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.
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.
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.

Full Information

First Posted
June 3, 2016
Last Updated
April 2, 2019
Sponsor
Syracuse University
Collaborators
Texas Woman's University
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1. Study Identification

Unique Protocol Identification Number
NCT02940899
Brief Title
Syracuse University Fit Families Program: Autism
Acronym
SUFFP
Official Title
Fit Families Program for Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Syracuse University
Collaborators
Texas Woman's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Syracuse University Fir Families Program (SUFFP)
Arm Type
Active Comparator
Arm Description
SUFFP is a randomized control trial comparing two groups of families of children with autism spectrum disorders. 20 families participated in the intervention program
Arm Title
Control: Syracuse University Fir Families Program (SUFFP)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention: Syracuse University Fir Families Program (SUFFP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Activity
Description
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.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Motor skills of Parents and Children
Description
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.
Time Frame
Two years
Title
Adaptive behavior
Description
To asses adaptive behavior of children with autism spectrum disorders. This outcome will be measured using the Vinland Adaptive Behavior Scales.
Time Frame
Two years
Title
Reported Behavior Problems
Description
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).
Time Frame
Two years
Title
Sensory Processing
Description
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).
Time Frame
Two years
Title
Quality of Life of Parents of Children with Autism Spectrum Disorders
Description
To asses the quality of life children with autism spectrum disorders. This outcome will be measured using self reports.
Time Frame
Two years
Title
Physical Activity Experiences
Description
To asses parents' experiences regarding physical activity. This will be measured using qualitative parent interviews.
Time Frame
Two years
Title
Physical Activity Experiences
Description
To asses parents' experiences regarding physical activity. This will be measured using quantitative parent reports.
Time Frame
Two years
Title
Cardiovascular Health
Description
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.
Time Frame
Two years
Title
Cardiovascular Health
Description
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.
Time Frame
Two years
Title
Cardiovascular Health
Description
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.
Time Frame
Two years
Title
Cardiovascular Health
Description
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.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Columna, Ph.D
Organizational Affiliation
Syracuse University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13244
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Syracuse University Fit Families Program: Autism

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