- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03625297
Shelter Cat Adoption in Families of Children With Autism (Feline Friends)
October 29, 2020 updated by: Gretchen K Carlisle, University of Missouri-Columbia
Shelter Cat Adoption in Families of Children With Autism: Impact on Cat Stress and Children's Social Skills and Anxiety ("Feline Friends")
The overall purpose of this study is to investigate the effect of the introduction of a shelter cat into the family of a child with Autism Spectrum Disorder on the social skills and anxiety of the child, and to examine stress in the cat.
Study Overview
Detailed Description
Many families in the United States live with cats as companion animals, including families of children with Autism Spectrum Disorder (ASD).
One in 68 children are diagnosed with ASD.
There is no cure for ASD, and no one treatment works for all children.
Symptoms of ASD include a lack of social skills and anxiety.
Companion animals have been helpful for children with ASD.
However, no one has studied stress of cats living in families of children with ASD.
This study will place 64 pre-screened shelter cats in pre-screened homes and monitor the stress of the cats.
Cats ages 10 months to four years that have been screened for calm behavior using a temperament, test will be adopted by families in the study.
Families will also be screened for pet issues.
No cat will be placed in a home with a child who has a history of aggression to animals.
The study will also examine the social skills and anxiety of the children with ASD, and bonding of the parents and children with their cats.
Five to eight million dogs and cats are relinquished to animal shelters in the United States each year.
Thirty-eight percent of cats are given up for behavioral reasons.
Studying cat stress and the placement of cats, with calm and non-aggressive characteristics into homes of families of children with ASD may help shed light on the likely success of the relationships between shelter cats and these families.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Columbia, Missouri, United States, 65211
- University of Missouri
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- child with diagnosis of Autism Spectrum Disorder
- no cat currently living with the family
- willingness to adopt a shelter cat
- English speaking
- live within 125 miles of Columbia, Missouri
Exclusion Criteria:
- child with Autism Spectrum Disorder having any history of animal aggression
- children with cat allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Shelter cat adoption control group
Families of children with autism will complete a control period with no intervention, then adopt a shelter cat after completion of the control period
|
|
|
EXPERIMENTAL: shelter cat adoption
Families of children with autism will adopt a shelter cat
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families will adopt a shelter cat
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Social Skills of child with autism over time from baseline to 6, to 12 and to 18 weeks
Time Frame: Control: Baseline, 6, 12 and 18 weeks Treatment: Baseline, 6, 12 and 18 weeks
|
Social skills measured using the Social Skills Improvement System Rating Scale (SSiS-RS) with scores from 0-138.
|
Control: Baseline, 6, 12 and 18 weeks Treatment: Baseline, 6, 12 and 18 weeks
|
|
Change in Anxiety of child with autism over time from baseline to 6, to 12 and to 18 weeks
Time Frame: Control: Baseline, 6, 12 and 18 weeks Treatment: Baseline, 6, 12 and 18 weeks
|
Anxiety measured using the Screen for Child Related Anxiety Disorders (SCARED) with scores from 0-82.
|
Control: Baseline, 6, 12 and 18 weeks Treatment: Baseline, 6, 12 and 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in parent Human-animal Bonding over time from 2-3 days, to 6, to 12 and 18 weeks
Time Frame: Baseline, 6, 12 and 18 weeks Treatment: Baseline, 2-3 days, 6, 12 and 18 weeks
|
bonding of parent and cat using Lexington Attachment to Pets Scale with scores from 0-54.
|
Baseline, 6, 12 and 18 weeks Treatment: Baseline, 2-3 days, 6, 12 and 18 weeks
|
|
change in child Human-animal Bonding over time from 2-3 days, to 6, to 12 and 18 weeks
Time Frame: Baseline, 6, 12 and 18 weeks Treatment: Baseline, 2-3 days, 6, 12 and 18 weeks
|
bonding of child with autism and cat using the Companion Animal Bonding Scale with scores from 8-40
|
Baseline, 6, 12 and 18 weeks Treatment: Baseline, 2-3 days, 6, 12 and 18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gretchen K Carlisle, PhD, University of Missouri-Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 23, 2017
Primary Completion (ACTUAL)
October 1, 2019
Study Completion (ACTUAL)
October 1, 2019
Study Registration Dates
First Submitted
July 17, 2018
First Submitted That Met QC Criteria
August 8, 2018
First Posted (ACTUAL)
August 10, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 2, 2020
Last Update Submitted That Met QC Criteria
October 29, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008460
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.