Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000699369
Ethics application status
Approved
Date submitted
11/05/2017
Date registered
16/05/2017
Date last updated
16/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes of a therapeutic program with children and adolescents with Autism using trained assistance dogs
Scientific title
Outcomes of a therapeutic program using trained assistance dogs in relation to reducing behavioural symptoms and promoting play engagement in children and adolescents with Autism.
Secondary ID [1] 291929 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Autism 303260 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302681 302681 0 0
Occupational therapy
Mental Health 302689 302689 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will take part in an occupational therapy session designed to promote engagement in play activities to meet behavioural and social goals set by the parents and occupational therapist. The assistance dogs will be used in the sessions at a variety of levels depending on the responses on the participant: at a basic level the dog will just be in the room, or the dog may sit close or next to the participant, or the dog may be actively involved in an activity (such as brushing the dog, or touching it in some way) or the dog may be fully involved such as putting a lead on the dog and walking it through an obstacle course, or taking the dog for a walk outside.
Each session will last for an hour, and participants will be offered five weekly sessions.
An Occupational Therapist will run the sessions
Sessions are run on an individual basis with the dog trainer and a parent present, and will take place in a treatment room at the Assistance Dogs Australia centre.
Records will be kept of participant's attendance
Intervention code [1] 298050 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302086 0
Achievement of goals for the five session program using Goal Attainment Scaling and a non standardised parent survey focused on social interaction, language and communication, engagement and calmness.
Timepoint [1] 302086 0
Five weeks
Primary outcome [2] 302093 0
Social Responsiveness Scale scores
Timepoint [2] 302093 0
Baseline and five weeks
Secondary outcome [1] 334700 0
Behavioural observations of session recordings. These will be assessed using a non standardised observation sheet that is being developed as part of this study, and will be scored by someone who was not part of the therapy session using video-recordings. This will include notes and simple counts of positive behaviours: Verbal behaviour towards the dog or therapist, Nonverbal behaviour towards the dog or therapist, Spontaneous language use, Spontaneous behaviour towards the dog or therapist, Play with the dog or therapist, Visual contact with the dog or therapist, Smiling towards the dog or therapist, or Imitating the therapist’s actions, as well as Negative behaviours such as Self-stimulatory activities or behaviours, Self-play or self-absorption,
Hand flapping, Repetitive behaviours (hand posturing, humming, clicking, spinning objects), etc
Disruptive or aggressive behaviours/tantrums
Timepoint [1] 334700 0
Five weeks

Eligibility
Key inclusion criteria
Participants aged between 5 and 20 years
Participants to have had a diagnosis of ASD for over 12 months
Parents and participants to have attended a PAWS workshop (run by Assistance Dogs Australia)
Participants to be comfortable around dogs and to have a positive view of dogs.
Parents/caregivers to be available to attend all sessions.
Minimum age
5 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who do not fit the inclusion criteria
Participants who do not wish to participate in the session/s
Participants or parents that do not communicate in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Simple pre-post study design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis of baseline assessment and follow up assessment data
Paired t-tests of continuous outcome measure scores
Qualitative analysis of video recordings of participant behaviour and engagement during sessions
A sample of 75 participants has been set by Assistance Dogs Australia who have already recruited participants for this study through their PAWS workshop program consisting of families who are interested in applying for an assistance dog.
Qualitative analysis of parent interviews

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/06/2017
Actual
Date of last participant enrolment
Anticipated
6/11/2017
Actual
Date of last data collection
Anticipated
8/12/2017
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15968 0
2233 - Engadine

Funding & Sponsors
Funding source category [1] 296433 0
Charities/Societies/Foundations
Name [1] 296433 0
Scentre Group Grant - Westfield
Country [1] 296433 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Assistance Dogs Australia
Address
PO Box 455
Engadine NSW 2233
Country
Australia
Secondary sponsor category [1] 295387 0
University
Name [1] 295387 0
University of Sydney, Faculty of Health Sciences
Address [1] 295387 0
75 East Street
Lidcombe
NSW 2141
Country [1] 295387 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297664 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 297664 0
Ethics committee country [1] 297664 0
Australia
Date submitted for ethics approval [1] 297664 0
13/12/2016
Approval date [1] 297664 0
10/01/2017
Ethics approval number [1] 297664 0
2016/984

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74746 0
A/Prof Lynette Mackenzie
Address 74746 0
Discipline of Occupational Therapy
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe, NSW 2141
Country 74746 0
Australia
Phone 74746 0
+61 2 93519832
Fax 74746 0
Email 74746 0
[email protected]
Contact person for public queries
Name 74747 0
Claire Dickson
Address 74747 0
Assistance Dogs Australia
PO Box 455
Engadine NSW 2233
Country 74747 0
Australia
Phone 74747 0
+61 2 9548 3355
Fax 74747 0
Email 74747 0
[email protected]
Contact person for scientific queries
Name 74748 0
Lynette Mackenzie
Address 74748 0
Discipline of Occupational Therapy
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe, NSW 2141
Country 74748 0
Australia
Phone 74748 0
+61 2 9351 9832
Fax 74748 0
Email 74748 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.