NCT04859998

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 21, 2021

Last Update Submit

April 23, 2021

Conditions

Keywords

dog-assistedgaitposturalcommunicationHuman-animal interactionfall risk

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 INTERVENTION

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 group

EXPERIMENTAL

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

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.

Also known as: animal-assisted therapy, animal-assisted intervention
Experimental group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

King Juan Carlos University

Móstoles, Madrid, 28933, Spain

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderCommunicationHuman-Animal Interaction

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Daniel Collado-Mateo, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
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

Locations