NCT03625297

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration 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

June 23, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

July 17, 2018

Last Update Submit

October 29, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    Baseline, 6, 12 and 18 weeks Treatment: Baseline, 2-3 days, 6, 12 and 18 weeks

Study Arms (2)

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

Other: shelter cat

Interventions

families will adopt a shelter cat

shelter cat adoption

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • child with Autism Spectrum Disorder having any history of animal aggression
  • children with cat allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Social SkillsAnxiety Disorders

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorMental Disorders

Study Officials

  • Gretchen K Carlisle, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study uses a two-group randomized, repeated measures design with a delayed treatment control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 17, 2018

First Posted

August 10, 2018

Study Start

June 23, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations