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Imitation-based Dog Assisted Intervention, for Children With Developmental Disabilities.

Primary Purpose

Physical Activity, Social Responsibility

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DAID
Dog walking
Sponsored by
Oregon State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Physical Activity

Eligibility Criteria

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

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/

Sites / Locations

  • Oregon State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

DAID

Dog walking

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Physical activity Change
Physical activity change will be measured through accelerometry

Secondary Outcome Measures

Full Information

First Posted
February 8, 2018
Last Updated
March 27, 2023
Sponsor
Oregon State 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
NCT03462407
Brief Title
Imitation-based Dog Assisted Intervention, for Children With Developmental Disabilities.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon State 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
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Social Responsibility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized prospectively into one of three possible groups following initial assessments and screening (e.g., eligibility), 1) 15 participants in an experimental (DAID intervention), 2) 15 control participants (dog walking), 3) 15 waitlisted control participants (true control, waitlisted for DAID one-year after post-assessment 1 of the project).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DAID
Arm Type
Experimental
Arm Description
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.
Arm Title
Dog walking
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DAID
Intervention Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Dog walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity Change
Description
Physical activity change will be measured through accelerometry
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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/
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan MacDonald
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon State University
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97331
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Imitation-based Dog Assisted Intervention, for Children With Developmental Disabilities.

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