Clinical trial NCT06687850: Animal-Assisted Therapy in Pediatric Autism Spectrum Disorders
Official title: The Effect of Animal-Assisted Therapy on Prosocial Behavior in Children With Developmental Delay or Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Autism
Developmental Delay (Disorder)
Behavioral Concerns
Keywords: animal-assisted therapy
canine-assisted therapy
pediatric autism spectrum disorder
verbality
prosocial behavior
emotional regulation
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 13
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate the effect of animal-assisted therapy (AAT) on prosocial behavior and emotional regulation in children with developmental delay, behavioral concerns, or autism spectrum disorder. Service dog use in the pediatric population who have these concerns is increasing and more studies are indicated to determine best practice for incorporating canines into traditional therapy sessions to enhance therapeutic outcomes. The hypothesis for this study is that inclusion of the canine will enhance therapy sessions and produce a lasting effect on prosocial behavior and emotional regulation after AAT sessions have concluded.

Detailed description: Investigators are determining if a child's verbality affects interaction with the canine or changes the effect of animal-assisted therapy on prosocial behavior and emotional regulation in autistic children.

Eligibility criteria: Inclusion Criteria:

* Referred to the program for ASD diagnostic evaluation based on their development and behavior. Could have ASD, developmental delay, or behavioral concerns.

Exclusion Criteria:

* Afraid or allergic to canines

Primary outcomes:
measure: Targets of interaction during AAT sessions
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Human Interactive behaviors during AAT sessions
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Social Communication
timeFrame: During weekly animal-assisted therapy sessions from enrollment to the end of treatment between 6 to 52 weeks
measure: Environmental Interactions
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 at the beginning of the study and the follow-up version is completed every 4 weeks and at the end of the study.
measure: Positive and Negative Affect Scale
timeFrame: The PANAS is administered weekly from the start to the end of the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Michele 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.