NCT06609122

Brief Summary

Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental disorder usually diagnosed in early childhood. Children with ASD exhibit social communication and interaction problems, which may cause deficits in social-emotional reciprocity, problems with developing, maintaining, and understanding relationships, and abnormal nonverbal communicative behaviors such as impaired eye contact and body language. Some children with ASD have severe behavioral problems, such as stereotyped or repetitive motor movements, and extreme distress at small changes. ASD is a complex and individualized disorder, which creates challenges in treatment. Animal-assisted education (AAE) programmes have been introduced for children with special needs in other countries such as the United States and Australia. PAALS (Palmetto Animal Assisted Life Services) in the United States have introduced the Pet a PAALS Dog programme, which assists stressed students at USC (University of South Carolina). Assistance Dogs Australia has provided an Educational Support Dog Echo to Kalinda Support School, for children with a wide range of disabilities. Existing literature indicate the benefit of animal-assisted therapy on physical, behavioral, and cognitive disabilities, especially in social and communication disorders. Formally trained human-dog teams in animal-assisted interventions (AAI) can play a unique role in social and communicative development that schools, and caregivers may not be able to provide. Interacting with animal-assisted intervention dogs can increase children with ASD\'s social interaction, communication, and effective connection. Dogs can also provide emotional support in stressful situations such as calming the child down when they have a tantrum. Moreover, animal-assisted therapy has shown to decrease stress levels, anxiety, and restrictive and repetitive behavior patterns. Dogs as pets can also bring significant improvements to caregivers of children with ASD and improve conflict management. Based on a successful pilot trial in 2019 with 8 children showed that AAI program has a positive effect on the performance of children with ASD, The investigator proposed an observational study that tracks the effectiveness of an animal-assisted intervention programme in a local school for children with ASD and developmental disabilities.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

6.3 years

First QC Date

September 10, 2024

Last Update Submit

September 23, 2024

Conditions

Keywords

Animal Assisted InterventionAnimal Assisted EducationAnimal Assisted TherapyTherapy DogAnimal Assisted Education DogAutism

Outcome Measures

Primary Outcomes (2)

  • Strengths and Difficulties Questionnaire (SDQ)

    The Strengths and Difficulties Questionnaire (SDQ) is a common tool used to screen behavior in children and teenagers aged 3-16 years. It looks at emotional and behavioral challenges in five areas: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Parents, teachers, or the young person themselves usually complete the 25-question survey. The responses help identify strengths and difficulties in different aspects. The SDQ is employed in clinics, research, and schools to spot children at risk of emotional or behavioral issues and track progress in intervention programs. Based on the scoring of SDQ, 80% of children scored normal, 10% borderline, and 10% abnormal.

    within two weeks Pre-treatment and within two weeks Post-treatment

  • Pediatric Quality of Life Inventory (PedsQL) 4.0 Core

    The Pediatric Quality of Life Inventory (PedsQL) 4.0 Core is a questionnaire used to assess the well-being of children and teenagers. It looks at their physical, emotional, social, and school functioning. Kids aged 2-18 years can fill it out, as well as their parents or caregivers. The results give a detailed picture of the child\'s quality of life. This tool is valuable in clinics, research, and schools to understand how health issues or treatments affect a child\'s overall happiness and health. The PedsQLTM 4.0 Generic Core Scales use a scale from 0-100, where higher scores mean better Health-Related Quality of Life. To calculate scores, reverse score the items on a 0-4 scale to a 0-100 scale: 0=100, 1=75, 2=50, 3=25, 4=0.

    within two weeks Pre-treatment and within two weeks Post-treatment

Study Arms (2)

Control Group

NO INTERVENTION

Students join the standard class at the same time slot

Intervention Group

EXPERIMENTAL

The teacher will work on the training goals with incorporation of the dog in the activity. For example, in the training of comprehension of commands, participant would be asked to take one item out of a few items, and then to pass to the dog. If correction of articulation errors is indicated (e.g. misarticulated /k/), training items would be picked under consideration of linkage to dogs. Words like '狗' /kɐu2/ and '教' /kau3/ would be used as stimuli during training.

Other: Animal Assisted Intervention

Interventions

Animal-assisted intervention (AAI) is a therapeutic approach that involves animals as part of a treatment plan to improve physical, social, emotional, or cognitive functioning in individuals. Animals such as dogs, cats, horses, and even dolphins are commonly used in AAI due to their ability to provide comfort, companionship, and motivation. AAI can take many forms, including animal-assisted therapy (AAT), where a trained therapy animal works with a licensed healthcare professional to achieve specific treatment goals. Animal-assisted activities (AAA) involve interactions with animals in a more casual and recreational setting, such as visits to hospitals or nursing homes to provide companionship and emotional support.

Intervention Group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Either gender aged 6 to 18 years old; have mild to moderate autism

You may not qualify if:

  • Who are not interested in the intervention and/or afraid of animals; who are allergic to animals; with severe mental/cognitive issues that might lead to injuries/ inconvenience to the animals and increase the likelihood of undersired events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Special Schools in Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

Related Publications (4)

  • First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. No abstract available.

    PMID: 23995026BACKGROUND
  • Winkle M, Crowe TK, Hendrix I. Service dogs and people with physical disabilities partnerships: a systematic review. Occup Ther Int. 2012 Mar;19(1):54-66. doi: 10.1002/oti.323. Epub 2011 Aug 19.

    PMID: 21858889BACKGROUND
  • Hall SS, Wright HF, Mills DS. What Factors Are Associated with Positive Effects of Dog Ownership in Families with Children with Autism Spectrum Disorder? The Development of the Lincoln Autism Pet Dog Impact Scale. PLoS One. 2016 Feb 19;11(2):e0149736. doi: 10.1371/journal.pone.0149736. eCollection 2016.

    PMID: 26894820BACKGROUND
  • Wong WHS, Chen C, Tso A, So HK, Wong JPY, Tinsley H, Chung CHY, Luk RKW, Ip P. Dog-assisted therapy on Hong Kong children with autism spectrum disorder: an exploratory randomized controlled trial. Eur J Pediatr. 2026 Jan 9;185(1):64. doi: 10.1007/s00431-025-06720-6.

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Dr. Wilfred Wong, p.hD. In Public Health

    Department of Paediatrics & Adolescent Medicine, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Wilfred Wong

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are unaware of which treatment they are receiving, but the researchers know.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 24, 2024

Study Start

April 1, 2019

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

September 25, 2024

Record last verified: 2024-09

Locations