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

Primary Purpose

Autism Spectrum Disorder, Social Skills

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Animal-assisted intervention
Social skills group
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Therapy dog, Autism Spectrum Disorder, Social skills, Group therapy

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Texas Tech UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Social Skills Control (A-A)

Social Skills Dog (A-B)

Social Skills Dog (B-A)

Arm Description

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

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").

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.

Outcomes

Primary Outcome Measures

Verbal utterances
The investigators will record total frequency and rate of verbal utterances during each session.
Direction of utterances
The investigators will record the direction of the utterance: towards peers, the therapist, or the therapy dog.
Quality of utterance
The investigators will record the quality of the utterances (e.g., rude and friendly words, greetings, etc.).
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.
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.
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.
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.
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.

Secondary Outcome Measures

Quality of instruction: correct and timely feedback
The quality of instruction will be measured by trained observers through the proportion of correct and timely feedback given to the children.
Quality of instruction: adherence to the program script
The quality of instruction will be measured by trained observers by marking the level of adherence to the program script.
Quality of instruction: attention to children
The quality of instruction will be measured by trained observers by recording the level of attention provided for each child.

Full Information

First Posted
March 6, 2019
Last Updated
September 4, 2019
Sponsor
Texas Tech University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03873831
Brief Title
Effects of Therapy Dogs on Social Behavior in Group Social Skills Instruction With Children With Autism
Official Title
Clinical Trial of the Effects of Therapy Dogs on Social Behavior in Group Social Skills Instruction With Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Approximately 1 in 68 children are diagnosed with autism spectrum disorder (ASD). The most detrimental hallmarks of autism are significant deficits in social and conversational skills, resulting in difficulties forming and maintaining social relationships. Children who have few friends are at a high risk for having depression, doing poorly in school, and not being employed as adults. Animal-Assisted Interventions (AAI) have been shown to increase social behavior in both children with ASD as well as in various human populations. Children with ASD display more social behavior in a classroom setting when a therapy dog is present, but while the effect dogs have on increasing social behavior has been well-established, the mechanism by which this increase occurs remains elusive. Our long-term goal is to identify causal mechanisms that may ameliorate the social behavior deficit in autism. The specific goal of this research is to identify the mechanisms involved in the social-enhancing effect of dogs on children with ASD. Our central hypothesis is that therapy dogs have a specific and measurable effect on children's social behaviors. Furthermore, by directly testing a number of significant confounds frequently found in AAI research (novelty effects and the effects of the dog on the therapist), the investigators will rule out alternative hypotheses. It has been suggested that the effects of AAI are partly caused by the novelty of having an animal in a location where animals are not typically seen (such as a classroom) rather than caused by an underlying feature specific to the animal. Additionally, the therapist's potentially altered quality of instruction in response to the presence of a dog in the room has not been previously explored. The investigators will attain our goal by incorporating therapy dogs into an established group social skills instruction program for children with ASD, using a quasi-experimental, repeated-measures counter-balanced mixed design with physiological and behavioral outcome measures. Furthermore, using a rigorous experimental single-subject design, the investigators will assess the effect of the dogs on therapists. Group social skills instruction interventions based on the principles of applied behavior analysis (ABA) and that target conversational and communication skills have been shown as particularly successful at improving social behavior in individuals with ASD. Despite the beneficial outcomes, any educational interventions, especially those that require social interaction, can be a source of stress for children with ASD, and stress can impact learning and memory. Creating an educational setting that balances the levels of stress is beneficial. Dogs may have a stress-ameliorating effect on the child, thereby allowing social behavior to emerge during the instructional period and enhance the child's ability to learn social skills. Another barrier to effective instruction may be that peer-to-peer contact is perceived as highly aversive to children with ASD. Thus, by providing a non-judgmental therapy dog learning partner, the children may first practice social skills in a safer environment, free from negative feedback. Aim 1: Identify the mechanism by which dogs increase group social behavior in children with ASD. The investigators will directly test two complementary hypotheses: (1) stress-ameliorating effect of the dog on the child, and (2) the dog as a non-judgmental learning partner. The investigators predict that the presence of the dog in group social skills instruction program (n = 72 children, with 8 children per group) will not only improve the quantity and quality of social behavior, but also reduce physiological (salivary cortisol, heart rate, and electrodermal activity) and behavioral signs of stress compared to the absence of the dog. The investigators further predict that during therapy sessions with dogs, most of the children's social behavior will be directed towards the dog rather than peers. Aim 2: Identify if and how repeated exposure to the dog influences social behavior of children with ASD. The investigators hypothesize that repeated exposure to the therapy dog across sessions will alter 1) the preference to spend time with the dog, as measured by changes in time spent in proximity, and 2) the social-enhancing effects of the dog. Aim 3: Identify the effects of the dog on the therapist. The investigators hypothesize that during repeated sessions with the dog, therapists (n = 6) will experience less stress (as measured by salivary cortisol, heart rate, and electrodermal activity), engage in more social and affiliative behavior towards the children, and deliver higher quality instruction. The outcomes of this research will lead to significant enhancements in the current understanding of the mechanism by which dogs increase social behavior in children with ASD. The innovative combination of methodologies from animal science and ABA therapy is uniquely suited for the determination of the mechanism of the social-enhancement effect of dogs. By measuring both behavioral responses and physiological biomarkers of stress during the intervention, the investigators will determine the mechanism through a rigorous and all-inclusive approach. Furthermore, by directly assessing two key confounding variables, the novelty effect and the effect of the dog on the therapist, the investigators will pave the way for more rigorous research into AAI. Completion of this research will expand our knowledge about the mechanism by which dogs may benefit children with ASD, introduce new intervention methods to provide longer-term benefits for children, and provide a starting point for research into new interdisciplinary technology using animals in ABA-based therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Social Skills
Keywords
Therapy dog, Autism Spectrum Disorder, Social skills, Group therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social Skills Control (A-A)
Arm Type
Active Comparator
Arm Description
The children in the "A-A" condition, a true control, will remain without a dog for the full 10 weeks.
Arm Title
Social Skills Dog (A-B)
Arm Type
Experimental
Arm Description
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").
Arm Title
Social Skills Dog (B-A)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Animal-assisted intervention
Other Intervention Name(s)
Therapy dog
Intervention Description
The therapy dog is present during the session.
Intervention Type
Behavioral
Intervention Name(s)
Social skills group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Verbal utterances
Description
The investigators will record total frequency and rate of verbal utterances during each session.
Time Frame
Sessions 1 through 10 (duration of 10 weeks)
Title
Direction of utterances
Description
The investigators will record the direction of the utterance: towards peers, the therapist, or the therapy dog.
Time Frame
Sessions 1 through 10 (duration of 10 weeks)
Title
Quality of utterance
Description
The investigators will record the quality of the utterances (e.g., rude and friendly words, greetings, etc.).
Time Frame
Sessions 1 through 10 (duration of 10 weeks)
Title
Unwanted behavior
Description
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.
Time Frame
Sessions 1 through 10 (duration of 10 weeks)
Title
Social behavior
Description
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.
Time Frame
Sessions 1 through 10 (duration of 10 weeks)
Title
Heart Rate
Description
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.
Time Frame
Sessions 1 through 10 (duration of 10 weeks)
Title
Electrodermal activity
Description
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.
Time Frame
Sessions 1 through 10 (duration of 10 weeks)
Title
Salivary cortisol
Description
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.
Time Frame
Sessions 1 through 10 (duration of 10 weeks)
Secondary Outcome Measure Information:
Title
Quality of instruction: correct and timely feedback
Description
The quality of instruction will be measured by trained observers through the proportion of correct and timely feedback given to the children.
Time Frame
Maximum of 50 weeks
Title
Quality of instruction: adherence to the program script
Description
The quality of instruction will be measured by trained observers by marking the level of adherence to the program script.
Time Frame
Maximum of 50 weeks
Title
Quality of instruction: attention to children
Description
The quality of instruction will be measured by trained observers by recording the level of attention provided for each child.
Time Frame
Maximum of 50 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children 11-17 years of age Children with a diagnosis of autism spectrum disorder (ASD) Children with receptive and expressive language skills Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wesley Dotson, PhD, BCBA-D
Phone
(806) 834-0783
Email
wesley.dotson@ttu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley H Dotson, PhD, BCBA-D
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wesley Dotson, PhD, BCBA-D
Phone
806-834-0783
Email
wesley.dotson@ttu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The researchers are committed to sharing research data according to the most recent NIH guidelines (https://grants.nih.gov/grants/policy/data_sharing/), while also understanding our duty to protect the privacy of our research participants. De-identified data will be shared among PIs through OneDrive, a secure university web-based application.

Learn more about this trial

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

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