Autism Spectrum DisorderNCT04859998
Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism
A study testing dog-assisted therapy in people with Autism Spectrum Disorder and Autism, run by Daniel Collado-Mateo at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- dog-assisted therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 26 Apr 2021to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- dog-assisted therapy
- Keywords
- dog-assisted, gait, postural, communication, Human-animal interaction, fall risk
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Communication, Human-Animal Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dog-assisted therapyBehavioural
Also called animal-assisted therapy, animal-assisted intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: dog-assisted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in walking performance (10m)
Evaluation of the ability to walk 10 meters in a corridor (time spent)
Measured: 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)
Measured: At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and inmediately after the intervention (within 7 days after the last session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start26 Apr 2021 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Collado-Mateo
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación de Padres de Personas Con Autismo (APNA), Asociación Nuevo Horizonte, Federación Autismo Madrid
- Responsible party
- Sponsor-investigator, Daniel Collado-Mateo, Universidad Rey Juan Carlos
- Investigators
- Daniel Collado-Mateo, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859998
- Sponsor's protocol ID
- AATinAutism
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism: a Controlled Trial.
- ClinicalTrials.gov ID
- NCT04859998
- Acronym / sponsor ID
- AATinAutism
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- dog-assisted, gait, postural, communication, Human-animal interaction, fall risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Daniel Collado-MateoUniversity, hospital or other
- Collaborators
- Asociación de Padres de Personas Con Autismo (APNA), Asociación Nuevo Horizonte, Federación Autismo Madrid
- Study start
- 26 Apr 2021 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: dog-assisted therapyParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dog-assisted therapyAlso: animal-assisted therapy, animal-assisted interventionIt 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. | Behavioural | Experimental group |
Primary outcome
Changes in walking performance (10m)
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Evaluation of the ability to walk 10 meters in a corridor (time spent)
Changes in walking performance (6m)
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Evaluation of the ability to walk 6 meters in a corridor (time spent)
10 secondary outcomes
Changes in balance and risk of falling
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in communication without dog
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in communication with dog
Time frame: During sessions (first, intermediate and last one)
Changes in the ability to climb and descend stairs
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in step length (6m)
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in step length (10m)
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in cadence (6m)
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in cadence (10m)
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in duration of phases in the gait cycle (6m)
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in duration of phases in the gait cycle (10m)
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Collado-Mateo, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dog-assisted therapy in people with Autism Spectrum Disorder and Autism, run by Daniel Collado-Mateo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in walking performance (10m) (time frame: At baseline and inmediately after the intervention (within 7 days after the last session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.