Comparison Between a Live Canine or Toy Dog on Prosocial Behavior and Emotional Regulation in Autistic Children
NCT ID: NCT06915415
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
9 participants
INTERVENTIONAL
2023-10-01
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Animal-Assisted Therapy in Pediatric Autism Spectrum Disorders
NCT06687850
Effects of Therapy Dogs on Social Behavior in Group Social Skills Instruction With Children With Autism
NCT03873831
Impact of AAI Dogs on Performance and Behavior of Children with Autism
NCT06609122
Animal Assisted Intervention With Dogs for Children With ADHD
NCT05102344
Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial
NCT03017027
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
One group had a live canine incorporated into therapy sessions.
The therapist included a live therapy canine to interact with participants during therapy sessions for this group. The canine is trained to provide comfort and play games with participants. Participants received cognitive behavioral therapy, sensory integration therapy, and eye movement desensitization and reprocessing therapy based upon their presenting needs. Sessions lasted between 30 to 60 minutes once weekly. Caregivers for younger participants were present throughout the session while caregivers for adolescent children were able to attend the entire session, watch the session from a different room, or stay in the lobby and meet with the therapist and participant for the last 10 minutes of therapy to review the session and therapeutic strategies to incorporate throughout the week to address deficits in emotional regulation and prosocial behavior. Sessions lasted 6 to 8 weeks, and participants could re-enroll if they desired to continue therapy to address identified concerns.
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.
One group had a toy plush dog incorporated into therapy sessions.
The therapist included a toy plush dog to interact with participants during therapy sessions for this group. Participants received cognitive behavioral therapy, sensory integration therapy, and eye movement desensitization and reprocessing therapy based upon their presenting needs. Sessions lasted between 30 to 60 minutes once weekly. Caregivers for younger participants were present throughout the session while caregivers for adolescent children were able to attend the entire session, watch the session from a different room, or stay in the lobby and meet with the therapist and participant for the last 10 minutes of therapy to review the session and therapeutic strategies to incorporate throughout the week to address deficits in emotional regulation and prosocial behavior. Sessions lasted 6 to 8 weeks, and participants could re-enroll in the live canine group if they desired to continue therapy to address identified concerns.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Allergic to canines
3 Years
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Arkansas, Fayetteville
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michele Kilmer
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MIchele R Kilmer, DNP
Role: PRINCIPAL_INVESTIGATOR
The University of Arkansas
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arkansas
Fayetteville, Arkansas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Website for the university's autism program
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2307483365
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.