- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03462407
Imitation-based Dog Assisted Intervention, for Children With Developmental Disabilities.
March 27, 2023 updated by: Megan MacDonald, Oregon State University
Development and Evaluation of a Novel Imitation-based Dog Assisted Intervention, 'DIAD Training', to Increase Joint Activity and Social Wellbeing for Adolescents With Developmental Disabilities.
This R21 application will provide a multidisciplinary One Health approach to DAID physical activity intervention for adolescents with developmental disabilities and their family dog.
The novel intervention approach includes the use of the family dog in an established dog training protocol, focused on physical activity and aimed at improving physical activity, quality of life and social wellbeing for children with and without developmental disabilities.
Recent pilot work has revealed physical and social-emotional improvements in children with developmental disabilities following an animal assisted intervention.
There has been relatively limited research focused on the physical activity of adolescents with developmental disabilities and there remains a critical need to develop strategies that will encourage an active lifestyle for adolescents with and without developmental disabilities.
Animal assisted therapy has known positive impacts on morale and is also known to reduce depressive psychological symptoms for children and adults.
Yet, traditional 'service dogs' are prohibitively expensive for many families.
Dog ownership alone is known to improve health-related physical activity.
Thus, a critical need exists to create physical activity interventions that are easily accessible and provide manageable home-based physical activity adherence, but that are less expensive than traditional service dogs.
To achieve these goals the investigators of this project have developed the following specific aims: 1) To develop and evaluate a novel DAID dog training program to promote physical activity in children with and without developmental disabilities; 2) To determine what impact participation in a DAID dog-training program has on the child's quality of life, feelings of social wellbeing and the child-dog relationship.
The long term goal of this research is to improve the lives of adolescents with and without developmental disabilities.
This research supports the One Health initiative and brings together aspects of improving health related to human and animal development.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Several publications have demonstrated the extent of physical activity deficits in adolescent children with DD, however very few interventions have targeted this health disparity.
Not only do significant disparities exist when children with DD are compared to their peers without disabilities, but without intervention, physical activity behaviors in children with DD further decline with age.
The investigators, have successfully worked together on animal assisted interventions, ultimately focused on promoting physical activity in children with disabilities.
Preliminary data strongly support the conclusion that physical activity, quality of life and social wellbeing improves with a family-dog-assisted intervention.
While dog-assisted interventions have become increasingly popular across applied settings, the need for further empirical evaluation is clear.
Given the rapid growth of scientific knowledge in the areas of developmental disabilities, human-animal interactions and canine behavior in recent years, the development and empirical evaluation of new animal assisted intervention programs built on a solid theoretical foundation and targeted to the needs of children with DD is especially critical.
In addition to the development of this intervention, we will employ an experimental design to conduct within- and between-group evaluations that will be used to assess the efficacy of the proposed DAID intervention, as well as its relative value when compared with a traditional dog walking intervention and waitlist control (true control).
To further strengthen our approach, the investigators will use a combination of objective validated physical (physical activity accelerometers), self-report (Quality of Life, Dog Care Responsibility Inventory, and Pet Relationship & Friendship Scales) and behavioral measures (Child-dog/Dog-child proximity seeking, sociability and attachment) to evaluate program outcomes.
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Corvallis, Oregon, United States, 97331
- Oregon State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between 8- 17 years with or without a disability (per parental report)
- Has a family dog (dog in the home)
Exclusion Criteria:
- Not able to follow basic instructions/
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DAID
Trained assistants will help participants train their dog to engage in imitation based dog training, using positive reinforcement training (operant conditioning) focused on physical activities.
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The DAID intervention group will engage in imitation based dog training, using positive reinforcement training (operant conditioning) to teach their dog to copy the physical actions they demonstrate on the command "Do it".
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Active Comparator: Dog walking
Trained assistants will help children train their dog to walk on a loose leash (eliminate pulling behavior) during this period using positive training techniques.
The focus of this group will be on appropriate walking behavior to facilitate enjoyable independent dog-walking at home.
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Children will participate in dog walking.
Trained assistants will teach the children to teach their dog basic commands.
Dog walking will occur during the intervention phase and children will be encourage to walk their dogs at home.
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No Intervention: Control
This group will all own family dogs but will not participate in either intervention during year 1.
All participants assigned to the waitlist will be offered the DAID intervention the subsequent summer.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity Change
Time Frame: Baseline; Immediately post intervention (after 2- 5 weeks); one-year post intervention; a fourth immediate post-intervention for waitlisted participants who participate in the intervention (~1 year and 1 month)
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Physical activity change will be measured through accelerometry
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Baseline; Immediately post intervention (after 2- 5 weeks); one-year post intervention; a fourth immediate post-intervention for waitlisted participants who participate in the intervention (~1 year and 1 month)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Anticipated)
August 30, 2024
Study Completion (Anticipated)
August 30, 2024
Study Registration Dates
First Submitted
February 8, 2018
First Submitted That Met QC Criteria
March 5, 2018
First Posted (Actual)
March 12, 2018
Study Record Updates
Last Update Posted (Actual)
March 29, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7848 (CTEP)
- 1R21HD091895-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The proposed research will involve a small sample (45 subjects) of adolescents recruited from youth programs within Corvallis and the surrounding counties/ communities including programs targeting children with developmental disabilities.
Participants must also have a family dog to participate in this study.
Even with the removal of all identifiers, the investigators believe that it would be difficult to protect the identities of subjects given the small region of recruitment and disability/ age characteristics of subjects and their family dogs.
Therefore, the investigators are not planning to share the data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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