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Trial record 6 of 101 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

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

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ClinicalTrials.gov Identifier: NCT03873831
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sasha Protopopova, Texas Tech University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Social Skills Behavioral: Animal-assisted intervention Behavioral: Social skills group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of the Effects of Therapy Dogs on Social Behavior in Group Social Skills Instruction With Children With Autism
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Social Skills Control (A-A)
The children in the "A-A" condition, a true control, will remain without a dog for the full 10 weeks.
Behavioral: Social skills group
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.

Experimental: Social Skills Dog (A-B)
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
The therapy dog is present during the session.
Other Name: Therapy dog

Behavioral: Social skills group
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.

Experimental: Social Skills Dog (B-A)
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
The therapy dog is present during the session.
Other Name: Therapy dog

Behavioral: Social skills group
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 Measures :
  1. Verbal utterances [ Time Frame: Sessions 1 through 10 (duration of 10 weeks) ]
    The investigators will record total frequency and rate of verbal utterances during each session.

  2. Direction of utterances [ Time Frame: Sessions 1 through 10 (duration of 10 weeks) ]
    The investigators will record the direction of the utterance: towards peers, the therapist, or the therapy dog.

  3. Quality of utterance [ Time Frame: Sessions 1 through 10 (duration of 10 weeks) ]
    The investigators will record the quality of the utterances (e.g., rude and friendly words, greetings, etc.).

  4. Unwanted behavior [ Time Frame: Sessions 1 through 10 (duration of 10 weeks) ]
    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.

  5. Social behavior [ Time Frame: Sessions 1 through 10 (duration of 10 weeks) ]
    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.

  6. Heart Rate [ Time Frame: Sessions 1 through 10 (duration of 10 weeks) ]
    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.

  7. Electrodermal activity [ Time Frame: Sessions 1 through 10 (duration of 10 weeks) ]
    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.

  8. Salivary cortisol [ Time Frame: Sessions 1 through 10 (duration of 10 weeks) ]
    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 :
  1. Quality of instruction: correct and timely feedback [ Time Frame: Maximum of 50 weeks ]
    The quality of instruction will be measured by trained observers through the proportion of correct and timely feedback given to the children.

  2. Quality of instruction: adherence to the program script [ Time Frame: Maximum of 50 weeks ]
    The quality of instruction will be measured by trained observers by marking the level of adherence to the program script.

  3. Quality of instruction: attention to children [ Time Frame: Maximum of 50 weeks ]
    The quality of instruction will be measured by trained observers by recording the level of attention provided for each child.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873831


Contacts
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Contact: Alexandra Protopopova, PhD (806) 834-2882 a.protopopova@ttu.edu
Contact: Wesley Dotson, PhD, BCBA-D 806-834-0783 wesley.dotson@ttu.edu

Locations
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United States, Texas
Texas Tech University Not yet recruiting
Lubbock, Texas, United States, 79401
Contact: Alexandra Protopopova, PhD    806-834-2882    a.protopopova@ttu.edu   
Contact: Wesley Dotson, PhD, BACB-D    8068340783    wesley.dotson@ttu.edu   
Sponsors and Collaborators
Texas Tech University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Alexandra Protopopova, PhD Texas Tech University

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Responsible Party: Sasha Protopopova, Assistant Professor, Texas Tech University
ClinicalTrials.gov Identifier: NCT03873831     History of Changes
Other Study ID Numbers: Therapy Dogs Group Autism
R21HD095206 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sasha Protopopova, Texas Tech University:
Therapy dog
Autism Spectrum Disorder
Social skills
Group therapy

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders