NCT03462407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

6.2 years

First QC Date

February 8, 2018

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical activity Change

    Physical activity change will be measured through accelerometry

    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)

Study Arms (3)

DAID

EXPERIMENTAL

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.

Behavioral: DAID

Dog walking

ACTIVE COMPARATOR

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.

Behavioral: Dog walking

Control

NO INTERVENTION

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.

Interventions

DAIDBEHAVIORAL

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".

DAID
Dog walkingBEHAVIORAL

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.

Dog walking

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Between 8- 17 years with or without a disability (per parental report)
  • Has a family dog (dog in the home)

You may not qualify if:

  • Not able to follow basic instructions/

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Megan MacDonald

    Oregon State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2018

First Posted

March 12, 2018

Study Start

May 1, 2017

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

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.

Locations