NCT02940899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

3.9 years

First QC Date

June 3, 2016

Last Update Submit

April 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Motor skills of Parents and Children

    Two years

  • Adaptive behavior

    Two years

  • Reported Behavior Problems

    Two years

  • Sensory Processing

    Two years

  • Quality of Life of Parents of Children with Autism Spectrum Disorders

    Two years

  • +6 more secondary outcomes

Study Arms (2)

Intervention: Syracuse University Fir Families Program (SUFFP)

ACTIVE COMPARATOR

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)

Control: Syracuse University Fir Families Program (SUFFP)

ACTIVE COMPARATOR

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)

Interventions

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.

Control: Syracuse University Fir Families Program (SUFFP)Intervention: Syracuse University Fir Families Program (SUFFP)

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Luis Columna, Ph.D

    Syracuse University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 3, 2016

First Posted

October 21, 2016

Study Start

January 1, 2015

Primary Completion

November 30, 2018

Study Completion

December 30, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations