Effects of Therapy Dogs on Social Behavior in Group Social Skills Instruction With Children With Autism

NCT03873831 | Completed DMC

• 2 other identifiers: Therapy Dogs Group AutismR21HD095206
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Animal-Assisted Interventions (AAI) can increase social behavior in children with autism spectrum disorder (ASD), although the mechanism by which this occurs remains elusive. The central goal of this project is to identify the mechanisms involved in the social-enhancing effect of dogs on children with ASD. The investigators will incorporate therapy dogs into an established evidence-based, group social skills instruction program for children with ASD, using a controlled experimental design with between- and within- subject comparisons and physiological and behavioral outcome measures. The investigators predict therapy dogs to have a specific and measurable effect on children's social behavior and that this effect is gained through identifiable mechanisms. Specifically, the investigators hypothesize that (1) an integration of therapy dogs into group social skills instruction will result in reduced stress and improved social behavior compare to traditional group instruction; (2) repeated exposure to the therapy dog across sessions will increase a child's preference for spending time with the dog and will increase the social-enhancing effects of the dog; and (3) that the therapists will experience less stress, engage in more social and affiliative behavior towards the children, and deliver higher quality instruction during sessions that include dogs. The investigators will enroll 72 children with ASD into group social skills instruction classes taught by 6 therapists. Each child will experience a 10-week, 8-student class in which either (a) the first 5 weeks will involve a therapy dog, (b) the last 5 weeks will involve the therapy dog, or (c) the class will not involve a therapy dog. The therapists will teach the courses repeatedly across the three cycles of the program with different children, rotating through each condition. Social behavior, stress behavior, heart rate, electrodermal activity, and salivary cortisol concentrations of children and therapists will be assessed and compared across conditions. The direction of the children's social behavior towards the dog and peers and the changes in quality of instruction of therapists during dog sessions compared to no-dog sessions will also be assessed. The outcomes of this research will lead to significant enhancements in current interventions for individuals with ASD.

Conditions

Autism Spectrum Disorder; Social Skills

Keywords

Therapy dog; Autism Spectrum Disorder; Social skills; Group therapy

Outcome Measures

Primary Outcomes (8)

• Verbal utterances

  The investigators will record total frequency and rate of verbal utterances during each session.

  Sessions 1 through 10 (duration of 10 weeks)

• Direction of utterances

  The investigators will record the direction of the utterance: towards peers, the therapist, or the therapy dog.

  Sessions 1 through 10 (duration of 10 weeks)

• Quality of utterance

  The investigators will record the quality of the utterances (e.g., rude and friendly words, greetings, etc.).

  Sessions 1 through 10 (duration of 10 weeks)

• Unwanted behavior

  Data on the presence of anxious or problem behavior (e.g., tantrum, non-compliance, crying, stereotypy) will be collected using a partial-interval coding with 5-s time bins method.

  Sessions 1 through 10 (duration of 10 weeks)

• Social behavior

  Data on the presence of social behavior (e.g., smiling, proximity to others, speaking) will be collected using a partial-interval coding with 5-s time bins method.

  Sessions 1 through 10 (duration of 10 weeks)

• Heart Rate

  To obtain a continuous measure heart rate, the investigators will use a NeuroLynQ Galvanic Skin Response (GSR) unit (Shimmer, Boston, MA), which uses phasic conductance and an optical pulse sensing probe. The small portable wristband device attaches to three sensors that are placed on the fingers of the non-dominant hand using Velcro straps. The device is lightweight and comfortable. These devices will be placed on each student and therapist at the beginning of each session and removed at the end of each session. The data from the devices will be collected at the end of each session.

  Sessions 1 through 10 (duration of 10 weeks)

• Electrodermal activity

  To obtain a continuous measure of electrodermal activity, the investigators will use a NeuroLynQ Galvanic Skin Response (GSR) unit (Shimmer, Boston, MA), which uses phasic conductance and an optical pulse sensing probe. The small portable wristband device attaches to three sensors that are placed on the fingers of the non-dominant hand using Velcro straps. The device is lightweight and comfortable. These devices will be placed on each student and therapist at the beginning of each session and removed at the end of each session. The data from the devices will be collected at the end of each session.

  Sessions 1 through 10 (duration of 10 weeks)

• Salivary cortisol

  At the beginning and/or the end of the session, each child and therapist will be asked to provide a saliva sample. The saliva collection procedures are based on established practices with children and will involve placing a cotton swab Salimetrics Child Swab) into the child's mouth for 1 min.

  Sessions 1 through 10 (duration of 10 weeks)

Secondary Outcomes (3)

• Quality of instruction: correct and timely feedback

  Maximum of 50 weeks

• Quality of instruction: adherence to the program script

  Maximum of 50 weeks

• Quality of instruction: attention to children

  Maximum of 50 weeks

Study Arms (3)

Social Skills Control (A-A)

ACTIVE COMPARATOR

The children in the "A-A" condition, a true control, will remain without a dog for the full 10 weeks.

Behavioral: Social skills group

Social Skills Dog (A-B)

EXPERIMENTAL

The "A-B" condition will involve standard instruction for 5 weeks ("A"), followed by 5 weeks of group instruction while a therapy dog is present in the room ("B").

Behavioral: Animal-assisted intervention; Behavioral: Social skills group

Social Skills Dog (B-A)

EXPERIMENTAL

The "B-A" condition will be identical, except the first 5 weeks of instruction will include the dog, followed by 5 weeks of standard instruction with no dog.

Behavioral: Animal-assisted intervention; Behavioral: Social skills group

Interventions

Animal-assisted intervention BEHAVIORAL

The therapy dog is present during the session.

Also known as: Therapy dog

Social Skills Dog (A-B); Social Skills Dog (B-A)

Social skills group BEHAVIORAL

The group program is 10 weeks in duration, with 1-hour long sessions once per week. Children will be taught new social skills each week using an established teaching interaction procedure, in which the therapist first describes the target skill, provides a rational and context for the behavior, divides the skill into smaller steps, demonstrates the behavior, and has each learner role-play the skill while providing feedback in the form of praise and tokens and corrective instruction. The last week involves a probe "free-play" session, in which children are assessed in a more naturalistic environment without any corrective feedback from therapists.

Social Skills Control (A-A); Social Skills Dog (A-B); Social Skills Dog (B-A)

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children 11-17 years of age
• Children with a diagnosis of autism spectrum disorder (ASD)
• Children with receptive and expressive language skills

You may not qualify if:

• Foster children
• Children with a phobia of dogs as reported by a parent or any behavioral signs during the study (crying, withdrawing from dog, body shaking, verbal report, etc.)
• Children with a history of animal mistreatment, abuse, or aggressive behavior toward animals as reported verbally by parents and/or through the screening questionnaire (Children's Attitude and Behaviors towards Animals, CABTA), or any behavioral signs (attempts to swat, hit, pinch, kick or pull the dog's hair) during the study
• Children who have a service animal as reported by the parent

Sponsors & Collaborators

• Texas Tech University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79401, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Social Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Wesley H Dotson, PhD, BCBA-D

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, HRPP

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 14, 2019
• Study Start: May 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: April 26, 2021
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)