Clinical trial NCT06915415: Comparison Between a Live Canine or Toy Dog on Prosocial Behavior and Emotional Regulation in Autistic Children
Official title: The Effect of Animal-Assisted Therapy on Prosocial Behavior and Emotional Regulation in Autistic Children: Comparison Between a Live Canine and a Toy Canine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosocial Behavior
Emotional Regulation
Human Animal Bonding
Human Animal Interaction
Autism
Keywords: animal-assisted therapy
canine-assisted therapy
pediatric autism spectrum disorder
prosocial behavior
emotional regulation
mental health practitioners
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 9
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigated the human-animal interaction (HAI) and bond (HAB) between a canine trained in therapy techniques or a canine plush toy and youth with autism spectrum disorder (ASD) during animal-assisted therapy (AAT) sessions. The purpose of this study is to explore identified gaps in knowledge pertaining to AAT in pediatric ASD care management by documenting human interaction between either a live canine or the plush toy canine during AAT sessions and evaluating prosocial behaviors observed during and after AAT sessions.

This study addressed the following research questions:

1. How do children with autism ages 2 to 18 years interact with a live canine during AAT sessions?
2. How do children with autism ages 2 to 18 years interact with a toy plush dog during AAT sessions?
3. Is there a difference in HAI in the live canine group and the toy plush dog group?
4. Is there a difference in prosocial behavior observed during AAT sessions between the live canine group and the toy plush dog group?
5. Is there a difference in behavior after AAT sessions between the live canine group and the toy plush dog group? Participants were randomly assigned to either the live canine or toy plush dog group. Adaptive functioning and social responsiveness evaluations were obtained to compare baseline behavior between the two groups. Participants attended an AAT session once weekly for 6 to 8 weeks. Each group received the same therapy provided by the therapist; the only difference being the incorporation of a live canine during the therapy session. Caregivers completed a weekly assessment depicting participants' positive and negative affect at the beginning of each session. Caregivers also completed a monthly assessment noting strengths and difficulties in social functioning and behavior at the start of the first, middle, and final session. AAT sessions were recorded and behavior occurring during the sessions was coded to note HAI and HAB that occurred during the sessions.


Eligibility criteria: Inclusion Criteria

* Clinical diagnosis of autism spectrum disorder, developmental delay, or behavioral concerns.

Exclusion Criteria:

* Fearful of canines
* Allergic to canines

Primary outcomes:
measure: Number of targets of interaction initiated by participants during AAT sessions
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Number of human interactive behaviors initiated by participants during AAT sessions
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Number of social communication interactions initiated by participants during AAT sessions
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Number of environmental interactions initiated by participants during AAT sessions
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Emotional Displays
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Verbal Emotional Displays
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Interfering Behaviors
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Human canine interaction
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Affection
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Laughing
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Petting
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Play
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Fetch
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Hide and Seek
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Puzzles
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Care
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Brush
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Walking
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Communication
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Name
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Command
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Verbal Affirmation
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Comfort
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Head
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Face
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Back
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Belly
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Ears
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Hugs
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Kiss
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Treat
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Floor
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Laying
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Withdrawal
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Moves Away
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Hides
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Crying
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Saying "No!"
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Frequency
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Duration
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Intensity
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Talk
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Gestures
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Look
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Touch
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Affection
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Prosocial
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Strengths and Difficulties Questionnaire
timeFrame: The initial SDQ is completed by caregivers at the first session (day 1) and every 4 weeks throughout the study and at the end of the study (up to 12 weeks).
measure: Positive and Negative Affect Scale
timeFrame: The Positive and Negative Affect Schedule is administered at the first session of the study (day 1), and then weekly at each session throughout the study and at the end of the study (up to 12 weeks).
measure: Vineland-3
timeFrame: Baseline- the Vineland-3 provides baseline data of adaptive functioning and is administered within 6 months prior to Session 1.
measure: Social Responsiveness Scale- 2nd edition
timeFrame: Baseline- the SRS-2 provides baseline data of adaptive functioning and is administered within 6 months prior to Session 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: The University of Arkansas
name: MIchele R Kilmer, DNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kilmer M, Hong M, Randolph D, Reichel A, Huetter S, Bowden M, Kilmer C. Animal-assisted therapy in pediatric autism spectrum disorder: A case report. Nurse Pract. 2024 Mar 1;49(3):31-39. doi: 10.1097/01.NPR.0000000000000151.