Comparison Between a Live Canine or Toy Dog on Prosocial Behavior and Emotional Regulation in Autistic Children

NCT06915415 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-04-08

No results posted yet for this study

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.

Conditions

  • Prosocial Behavior
  • Emotional Regulation
  • Human Animal Bonding
  • Human Animal Interaction
  • Autism

Interventions

BEHAVIORAL

Animal-assisted therapy

One group had a live therapy canine included in therapy sessions who was trained to provide comfort measures and promote interaction with autistic children. He is a certified therapy and service dog and knows over 50 commands and is certified in 10 autism service dog tasks. Participants played with him at the beginning of the session. They could choose to play fetch or hide and seek. Participants could say commands to make him do tricks and give him a treat as a reward. The canine would lay at participants' feet while the therapist was working on a skill in the clinic room. The canine would alert to the onset of anxiety and provide comfort measures. Participants could also cue the canine to provide comfort measures or could brush his fur and give him water as a prosocial behavior. Participants ended sessions with either fetch, soccer, or hide and seek.

BEHAVIORAL

Behavioral therapy

One group had a toy plush dog included in therapy sessions. The therapist would incorporate the toy plush dog in the seated portion of the session to practice social skills. Participants could brush the toy plush dog, pet it, and hold it during sessions.

Sponsors & Collaborators

  • University of Arkansas, Fayetteville

    lead OTHER

Principal Investigators

  • MIchele R Kilmer, DNP · The University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-08-05
Completion
2024-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06915415 on ClinicalTrials.gov