Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism
1 other identifier
interventional
24
1 country
1
Brief Summary
The aim is to evaluate the effects of a dog-assisted therapy program on physical function and communication in a sample comprised of 24 adults with autism spectrum disorder. The sample will be divided into 2 groups, a control group and an experimental group. Changes after 10 weeks (20 sessions) will be compared between-groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
April 21, 2021
CompletedFirst Posted
Study publicly available on registry
April 26, 2021
CompletedStudy Start
First participant enrolled
April 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2021
CompletedApril 26, 2021
April 1, 2021
3 months
April 21, 2021
April 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in walking performance (10m)
Evaluation of the ability to walk 10 meters in a corridor (time spent)
At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in walking performance (6m)
Evaluation of the ability to walk 6 meters in a corridor (time spent)
At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary Outcomes (10)
Changes in balance and risk of falling
At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in communication without dog
At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in communication with dog
During sessions (first, intermediate and last one)
Changes in the ability to climb and descend stairs
At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in step length (6m)
At baseline and inmediately after the intervention (within 7 days after the last session)
- +5 more secondary outcomes
Study Arms (2)
Control group
NO INTERVENTIONParticipants in this group will simply continue with their daily living and therapies. They will be assessed before and after the 10 week program but will not take part in it.
Experimental group
EXPERIMENTALParticipants in this group will take part in the 20 session dog-assisted therapy. This therapy will be added to their usual daily living and therapies. They will be assessed before and after the 10 week program.
Interventions
It will consist of 20 sessions conducted twice a week in the facilities of the association. It will involve different activities and physical exercises facilitated by the dogs. The program will be conducted in two associations (12 participants in each one, 6 belonging to the experimental and 6 belonging to the control group in each association) and in groups of three participants.
Eligibility Criteria
You may qualify if:
- Older than 40 years
- With autism spectrum disorder
- Able to walk autonomously, without help from other people.
- Able to climb and descent stairs autonomously, without help from other people.
You may not qualify if:
- Medical condition that contraindicates the proximity or contact with the animals with the animals on the part of the user.
- Allergy to dog epithelium.
- Phobias to dogs.
- History of aggression to animals.
- Users who do not submit a signed informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daniel Collado-Mateolead
- Asociación de Padres de Personas Con Autismo (APNA)collaborator
- Asociación Nuevo Horizontecollaborator
- Federación Autismo Madridcollaborator
Study Sites (1)
King Juan Carlos University
Móstoles, Madrid, 28933, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Collado-Mateo, PhD
Universidad Rey Juan Carlos
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 21, 2021
First Posted
April 26, 2021
Study Start
April 26, 2021
Primary Completion
July 15, 2021
Study Completion
July 15, 2021
Last Updated
April 26, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share