Physical ActivityNCT03462407
Imitation-based Dog Assisted Intervention, for Children With Developmental Disabilities.
A study testing DAID and Dog walking in people with Physical Activity and Social Responsibility, run by Oregon State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Social Responsibility
- What is being tested?
- DAID and Dog walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 8- 17 years with or without a disability (per parental report)
- Has a family dog (dog in the home)
Who cannot join
- Not able to follow basic instructions/
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Physical Activity, Social Responsibility
- Being tested
- DAID, Dog walking
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAIDBehavioural
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".
Dog walkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity Change
Physical activity change will be measured through accelerometry
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 May 2017
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Megan MacDonald, Oregon State University
- Investigators
- Megan MacDonald, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462407
- Sponsor's protocol ID
- 7848
- Other IDs
- 1R21HD091895-01
- Status last verified
- May 2024
- First submitted
- 8 Feb 2018
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03462407
- Acronym / sponsor ID
- 7848
- Conditions
- Physical Activity, Social Responsibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| DAID | Experimental | Behavioral: DAIDTrained assistants will help participants train their dog to engage in imitation based dog training, using positive reinforcement training (operant conditioning) focused on physical activities. |
| Dog walking | Active comparator | Behavioral: Dog walkingTrained 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. |
| 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Between 8- 17 years with or without a disability (per parental report)
- Has a family dog (dog in the home)
Key exclusion criteria (1 listed)
- Not able to follow basic instructions/
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAIDThe 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". | Behavioural | DAID |
| Dog walkingChildren 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. | Behavioural | Dog walking |
Primary outcome
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)
Physical activity change will be measured through accelerometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan MacDonald principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAID and Dog walking in people with Physical Activity and Social Responsibility, run by Oregon State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.