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Trial registered on ANZCTR


Registration number
ACTRN12618001801202
Ethics application status
Approved
Date submitted
29/09/2018
Date registered
5/11/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
5/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the impact of animal assisted therapy for preschool children with speech and language delay – A preliminary study
Scientific title
Exploring the impact of animal assisted therapy for preschool children with speech and language delay – A preliminary study
Secondary ID [1] 296214 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
language delay
 309695 0
speech delay
 309696 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308516 308516 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Animal-assisted therapy, or AAT, refers to a goal-directed intervention in which a specially trained animal-handler team is a key component of the treatment process (Animal Assisted Intervention International, 2013).

Two therapy dogs will be involved in the study: Basil, a 7-year-old male black standard poodle, and Polly, a 6-year-old female apricot standard poodle. The dogs will play an active role in the sessions with the children, who will touch, brush, walk, play and lay against the dogs, as deemed appropriate to the goals being addressed and the willingness of the children to engage in these tasks. Both animals have been certified as therapy dogs through Lead the Way Institute and Alpha Canine Professional and have had veterinary approval for therapy work.

Both animals are owned and handled by the student researcher (who is a fully qualified speech pathologist with four years clinical experience) and have had experience working with children and adults in a therapeutic context. Each child will be matched with either Polly or Basil in the initial session and will remain with that dog for the duration of the AAT treatment (excepting in the instance of illness or injury to the dog). The involvement of two dogs in the trial is to optimize the wellbeing of the dogs by minimizing the number of hours required of the dog to work per day.

The research will be conducted by the student researcher in a paediatric therapy room at Gippsland Lakes Community Health, which has been fitted with fixed video recording equipment, as well as a double-sided mirror and observation room. Materials used will be items routinely seen in a paediatric speech pathology session, including books, visual timetable, toys, picture cards, doll houses, chalkboards, bubbles and playdough. The therapy provided in these sessions will be business as usual for early intervention, with the therapy dogs acting as another tool to provide evidence-based therapeutic intervention

Following a repeated-measures design, all ten participants will undergo baseline assessment prior to treatment. Assessment will also be completed at weeks 5 (prior to crossover) and 10. Given the proximity in which assessments will be re-administered, as well as the young age of the children in the study, language sampling will be used to ensure ecological validity, as well as mitigate the possibility of practice effect which is a risk with using standardized formal assessments.

All participants will attend 45 minute sessions weekly for 10 weeks.
Intervention code [1] 312541 0
Rehabilitation
Comparator / control treatment
The study will employ a crossover design, so all participants will act as their own control. All participants will receive a total of 10 therapy sessions, 5 of which will include AAT and 5 which will be standard speech language therapy only.
Control group
Active

Outcomes
Primary outcome [1] 307598 0
Mean length of utterance in morphemes (MLU-m)

To be audio recorded and transcribed by the student researcher, and then assessed by final year speech pathology students who will be trained in analysing the data and blinded to the treatment group.
Timepoint [1] 307598 0
5 and 10 weeks post randomization
Primary outcome [2] 307599 0
The index of productive syntax (IPSyn)
To be audio recorded and transcribed by the student researcher, and then assessed by final year speech pathology students who will be trained in analysing the data and blinded to the treatment group.
Timepoint [2] 307599 0
5 and 10 weeks post randomization
Primary outcome [3] 307600 0
Number of different words (NDW),
To be audio recorded and transcribed by the student researcher, and then assessed by final year speech pathology students who will be trained in analysing the data and blinded to the treatment group.
Timepoint [3] 307600 0
5 and 10 weeks post randomization
Secondary outcome [1] 352387 0
Non-verbal communicative behaviours

This will be recorded using video recording equipment and then analysed by the student researcher and research supervisors using the Observation of Human-Animal Interaction for Research (OHAIRE) coding system
Timepoint [1] 352387 0
Data collection over the 10 weeks of treatment

All weekly 45 minute speech pathology sessions will be video recorded for each participant, and then coded using the tool mentioned above.

Eligibility
Key inclusion criteria
Inclusion criteria:

• Preschool age (no younger than 3 years) – this is the target age of study
• Diagnosis of speech and/or language delay – this is the target condition being treated
• English-speaking background
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

• Non-English-speaking background – this is to mitigate the influence of confounding variables given the nature of the condition being treated (English language)
• Global developmental delay/intellectual disability/other developmental disorder - There is currently only one published pilot study that has investigated AAT with children with language delay (Boyer & Mundschenk, 2016). Results from this study indicated that animal-assisted therapy produced best results when utilised with children with language delay without co-morbidities and was less effective with children also presenting with intellectual disability and Down syndrome.
• Diagnosis of autism spectrum disorder - The premise for excluding children with autism spectrum disorder and other developmental disabilities arose from a review of the literature. Much of the literature available on the use of animal-assisted therapy and communicative behaviours has been with children diagnosed with autism spectrum disorder, for which several studies have found promising results. However, there is far less evidence available on the use of this treatment for children with language delay without other diagnoses
• Known allergies/fear of dogs – in order to protect participant welfare and wellbeing. This will be discussed with parents/caregivers to determine

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



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2019
Actual
Date of last participant enrolment
Anticipated
1/07/2019
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
6
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 24191 0
3909 - Lakes Entrance
Recruitment postcode(s) [2] 24192 0
3875 - Bairnsdale

Funding & Sponsors
Funding source category [1] 300811 0
University
Name [1] 300811 0
La Trobe University
Country [1] 300811 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
PO Box 199
Bendigo Victoria 3552
Country
Australia
Secondary sponsor category [1] 300355 0
None
Name [1] 300355 0
Address [1] 300355 0
Country [1] 300355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301489 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 301489 0
Ethics committee country [1] 301489 0
Australia
Date submitted for ethics approval [1] 301489 0
31/10/2018
Approval date [1] 301489 0
21/02/2019
Ethics approval number [1] 301489 0

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

Contacts
Principal investigator
Name 87170 0
A/Prof Pauleen Bennett
Address 87170 0
Head of Department, Psychology and Counselling
La Trobe University
PO Box 199, Bendigo, Victoria, 3552
Country 87170 0
Australia
Phone 87170 0
+61 03 5444 7460
Fax 87170 0
Email 87170 0
pauleen.bennett@latrobe.edu.au
Contact person for public queries
Name 87171 0
Cheye Paoli
Address 87171 0
Gippsland Lakes Community Health
18-26 Jemmeson Street,
Lakes Entrance, Victoria 3909
Country 87171 0
Australia
Phone 87171 0
+61 0425 821 777
Fax 87171 0
Email 87171 0
ckpaoli@gmail.com
Contact person for scientific queries
Name 87172 0
Cheye Paoli
Address 87172 0
Gippsland Lakes Community Health
18-26 Jemmeson Street,
Lakes Entrance, Victoria 3909
Country 87172 0
Australia
Phone 87172 0
+61 0425 821 777
Fax 87172 0
Email 87172 0
ckpaoli@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Maintenance of confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
92Informed consent form    376028-(Uploaded-03-11-2018-10-38-13)-Study-related document.docx



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.