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

Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism: a Controlled Trial.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: dog-assisted therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Móstoles, Madrid, Spain, 28933
      • King Juan Carlos University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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.
Experimental: Experimental group; 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.	Behavioral: dog-assisted therapy; 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.; Other Names: animal-assisted therapy; animal-assisted intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and inmediately after the intervention (within 7 days after the last session)
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.	At baseline and inmediately after the intervention (within 7 days after the last session)
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.	During sessions (first, intermediate and last one)
Changes in the ability to climb and descend stairs	Evaluation of the ability to climb and descend stairs (10 steps)	At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in step length (6m)	Evaluation of the step length walking 6 meters in a corridor	At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in step length (10m)	Evaluation of the step length walking 10 meters in a corridor	At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in cadence (6m)	Evaluation of the cadence walking 6 meters in a corridor	At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in cadence (10m)	Evaluation of the cadence walking 10 meters in a corridor	At baseline and inmediately after the intervention (within 7 days after the last session)
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	At baseline and inmediately after the intervention (within 7 days after the last session)
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	At baseline and inmediately after the intervention (within 7 days after the last session)

Collaborators and Investigators

• Sponsor: Daniel Collado-Mateo
• Collaborators: Asociación de Padres de Personas Con Autismo (APNA); Asociación Nuevo Horizonte; Federación Autismo Madrid
• Investigators: Principal Investigator: Daniel Collado-Mateo, PhD, Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Anticipated): April 26, 2021
• Primary Completion (Anticipated): July 15, 2021
• Study Completion (Anticipated): July 15, 2021

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: gait; communication; fall risk; dog-assisted; Human-animal interaction; postural
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: AATinAutism

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No