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Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism

Primary Purpose

Autism Spectrum Disorder, Autism

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
dog-assisted therapy
Sponsored by
Daniel Collado-Mateo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring dog-assisted, gait, postural, communication, Human-animal interaction, fall risk

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • King Juan Carlos University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

Changes in walking performance (10m)
Evaluation of the ability to walk 10 meters in a corridor (time spent)
Changes in walking performance (6m)
Evaluation of the ability to walk 6 meters in a corridor (time spent)

Secondary Outcome Measures

Changes in balance and risk of falling
Using the Tinetti Assessment Tool. Minimum score = 0. Maximum score for gait = 12 points; Maximum score for balance component = 16 points. Maximum total score = 28 points. Higher scores mean lower risk of falling.
Changes in communication without dog
An observation scale designed by the group to evaluate the interaction and communication with other people. It is comprised by 14 items, scored as 1 (yes) and 0 (no). Minimum score = 0; Maximum score = 14. Higher scores mean higher communication.
Changes in communication with dog
An observation scale designed by the group to evaluate the interaction and communication with the dogs and other people. It is comprised by 38 items, scored as 1 (yes) and 0 (no). Minimum score = 0; Maximum score = 38. Higher scores mean higher communication.
Changes in the ability to climb and descend stairs
Evaluation of the ability to climb and descend stairs (10 steps)
Changes in step length (6m)
Evaluation of the step length walking 6 meters in a corridor
Changes in step length (10m)
Evaluation of the step length walking 10 meters in a corridor
Changes in cadence (6m)
Evaluation of the cadence walking 6 meters in a corridor
Changes in cadence (10m)
Evaluation of the cadence walking 10 meters in a corridor
Changes in duration of phases in the gait cycle (6m)
Evaluation of the duration of phases in the gait cycle walking 6 meters in a corridor
Changes in duration of phases in the gait cycle (10m)
Evaluation of the duration of phases in the gait cycle walking 10 meters in a corridor

Full Information

First Posted
April 21, 2021
Last Updated
April 23, 2021
Sponsor
Daniel Collado-Mateo
Collaborators
Asociación de Padres de Personas Con Autismo (APNA), Asociación Nuevo Horizonte, Federación Autismo Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04859998
Brief Title
Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism
Official Title
Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism: a Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2021 (Anticipated)
Primary Completion Date
July 15, 2021 (Anticipated)
Study Completion Date
July 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Collado-Mateo
Collaborators
Asociación de Padres de Personas Con Autismo (APNA), Asociación Nuevo Horizonte, Federación Autismo Madrid

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
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.
Detailed Description
The intervention program will consist of 20 sessions conducted twice a week in the facilities of the collaborator associations. Each session will be conducted in groups of 3 participants and will last 30 minutes. It will include a welcome part, a main part (based on different activities and physical exercises with the dog) and a closing part to say goodbye to the dogs. Physical function measures will be conducted before and after the completion of the study. The interaction and communication will be assessed during the sessions in the first, tenth and last ones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
dog-assisted, gait, postural, communication, Human-animal interaction, fall risk

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: one control (adults with autism that continues with their daily living and therapies) and one experimental group (adults with autism that receive the intervention program added to their daily living and therapies).
Masking
Investigator
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants 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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Behavioral
Intervention Name(s)
dog-assisted therapy
Other Intervention Name(s)
animal-assisted therapy, animal-assisted intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in walking performance (10m)
Description
Evaluation of the ability to walk 10 meters in a corridor (time spent)
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in walking performance (6m)
Description
Evaluation of the ability to walk 6 meters in a corridor (time spent)
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary Outcome Measure Information:
Title
Changes in balance and risk of falling
Description
Using the Tinetti Assessment Tool. Minimum score = 0. Maximum score for gait = 12 points; Maximum score for balance component = 16 points. Maximum total score = 28 points. Higher scores mean lower risk of falling.
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in communication without dog
Description
An observation scale designed by the group to evaluate the interaction and communication with other people. It is comprised by 14 items, scored as 1 (yes) and 0 (no). Minimum score = 0; Maximum score = 14. Higher scores mean higher communication.
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in communication with dog
Description
An observation scale designed by the group to evaluate the interaction and communication with the dogs and other people. It is comprised by 38 items, scored as 1 (yes) and 0 (no). Minimum score = 0; Maximum score = 38. Higher scores mean higher communication.
Time Frame
During sessions (first, intermediate and last one)
Title
Changes in the ability to climb and descend stairs
Description
Evaluation of the ability to climb and descend stairs (10 steps)
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in step length (6m)
Description
Evaluation of the step length walking 6 meters in a corridor
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in step length (10m)
Description
Evaluation of the step length walking 10 meters in a corridor
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in cadence (6m)
Description
Evaluation of the cadence walking 6 meters in a corridor
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in cadence (10m)
Description
Evaluation of the cadence walking 10 meters in a corridor
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in duration of phases in the gait cycle (6m)
Description
Evaluation of the duration of phases in the gait cycle walking 6 meters in a corridor
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in duration of phases in the gait cycle (10m)
Description
Evaluation of the duration of phases in the gait cycle walking 10 meters in a corridor
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Collado-Mateo, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Juan Carlos University
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28933
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism

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