Social SkillsNCT03625297
Shelter Cat Adoption in Families of Children With Autism (Feline Friends)
A study testing shelter cat in people with Social Skills and Anxiety, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Skills, Anxiety
- What is being tested?
- shelter cat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2017to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- child with Autism Spectrum Disorder having any history of animal aggression
- children with cat allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Skills, Anxiety
- Being tested
- shelter cat
- Medical subject headings
- Social Skills, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shelter catOther
families will adopt a shelter cat
| Study group | Role | What they receive |
|---|---|---|
| Shelter cat adoption control group | No intervention | Families of children with autism will complete a control period with no intervention, then adopt a shelter cat after completion of the control period |
| shelter cat adoption | Experimental | Families of children with autism will adopt a shelter cat Receives: Other: shelter cat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Skills of child with autism over time from baseline to 6, to 12 and to 18 weeks
Social skills measured using the Social Skills Improvement System Rating Scale (SSiS-RS) with scores from 0-138.
Measured: 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
Anxiety measured using the Screen for Child Related Anxiety Disorders (SCARED) with scores from 0-82.
Measured: Control: Baseline, 6, 12 and 18 weeks Treatment: Baseline, 6, 12 and 18 weeks
Secondary outcomes (2)
change in parent Human-animal Bonding over time from 2-3 days, to 6, to 12 and 18 weeks
bonding of parent and cat using Lexington Attachment to Pets Scale with scores from 0-54.
Measured: 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
bonding of child with autism and cat using the Companion Animal Bonding Scale with scores from 8-40
Measured: Baseline, 6, 12 and 18 weeks Treatment: Baseline, 2-3 days, 6, 12 and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start23 Jun 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social SkillsStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a two-group randomized, repeated measures design with a delayed treatment control group.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Winn Feline Foundation, Human Animal Bond Research Institute (HABRI)
- Responsible party
- Principal investigator, Gretchen K Carlisle, University of Missouri-Columbia
- Investigators
- Gretchen K Carlisle, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625297
- Sponsor's protocol ID
- 2008460
- Status last verified
- Oct 2020
- First submitted
- 17 Jul 2018
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shelter Cat Adoption in Families of Children With Autism: Impact on Cat Stress and Children's Social Skills and Anxiety ("Feline Friends")
- ClinicalTrials.gov ID
- NCT03625297
- Acronym / sponsor ID
- 2008460
- Conditions
- Social Skills, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Winn Feline Foundation, Human Animal Bond Research Institute (HABRI)
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a two-group randomized, repeated measures design with a delayed treatment control group.
| Arm | Type | Receives |
|---|---|---|
| Shelter cat adoption control group | No intervention | –Families of children with autism will complete a control period with no intervention, then adopt a shelter cat after completion of the control period |
| shelter cat adoption | Experimental | Other: shelter catFamilies of children with autism will adopt a shelter cat |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- child with Autism Spectrum Disorder having any history of animal aggression
- children with cat allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shelter catfamilies will adopt a shelter cat | Other | shelter cat adoption |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen K Carlisle, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shelter cat in people with Social Skills and Anxiety, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.