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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04859998
• Other study ID #: AATinAutism
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: July 15, 2021

Study information

• Verified date: April 2021
• Source: King Juan Carlos University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
Spain	King Juan Carlos University	Móstoles	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Daniel Collado-Mateo	Asociación de Padres de Personas Con Autismo (APNA), Asociación Nuevo Horizonte, Federación Autismo Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)