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Trial record 40 of 257 for:    Recruiting, Not yet recruiting, Available Studies | "Autistic Disorder"

Syracuse University Fit Families Program: Autism (SUFFP)

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ClinicalTrials.gov Identifier: NCT02940899
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Texas Woman's University
Information provided by (Responsible Party):
Luis Columna, Syracuse University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Other: Intervention: Syracuse University Fir Families Program (SUFFP) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Fit Families Program for Children With Autism
Actual Study Start Date : January 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Physical Activity [ Time Frame: Two years ]
    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 :
  1. Motor skills of Parents and Children [ Time Frame: Two years ]
    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.

  2. Adaptive behavior [ Time Frame: Two years ]
    To asses adaptive behavior of children with autism spectrum disorders. This outcome will be measured using the Vinland Adaptive Behavior Scales.

  3. Reported Behavior Problems [ Time Frame: Two years ]
    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).

  4. Sensory Processing [ Time Frame: Two years ]
    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).

  5. Quality of Life [ Time Frame: Two years ]
    To asses the quality of life children with autism spectrum disorders. This outcome will be measured using self reports.

  6. Physical Activity Experiences [ Time Frame: Two years ]
    To asses parents' experiences regarding physical activity. This will be measured using qualitative parent interviews.

  7. Physical Activity Experiences [ Time Frame: Two years ]
    To asses parents' experiences regarding physical activity. This will be measured using quantitative parent reports.

  8. Cardiovascular Health [ Time Frame: Two years ]
    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.

  9. Cardiovascular Health [ Time Frame: Two years ]
    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.

  10. Cardiovascular Health [ Time Frame: Two years ]
    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.

  11. Cardiovascular Health [ Time Frame: Two years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940899


Contacts
Contact: Tracy Cromp, MSW 315-443-2855 oirp@syr.edu

Locations
United States, New York
Syracuse University Recruiting
Syracuse, New York, United States, 13244
Contact: Syracuse University, PhD    315-443-9699    lcolumna@syr.edu   
Sponsors and Collaborators
Syracuse University
Texas Woman's University
Investigators
Principal Investigator: Luis Columna, Ph.D Syracuse University

Responsible Party: Luis Columna, Associate Professor, Syracuse University
ClinicalTrials.gov Identifier: NCT02940899     History of Changes
Other Study ID Numbers: 28491
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders