Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001402831p
Ethics application status
Submitted, not yet approved
Date submitted
29/07/2021
Date registered
18/10/2021
Date last updated
18/10/2021
Date data sharing statement initially provided
18/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Autism Diagnostic and Observation Schedule assessment Tool for Maori.
Scientific title
Cultural appropriateness of the use of Autism Diagnostic & Observation Schedule (ADOS-2) assessment tool for Maori: Whanau perspectives
Secondary ID [1] 304840 0
nil known
Universal Trial Number (UTN)
U1111-1269-0217
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 323046 0
Condition category
Condition code
Mental Health 320617 320617 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials used are: participant information sheet and consent form, self generated questionnaire, ADOS form and toys.

Procedure
One child and his/her family member will be seen at time in a private room in child development service, Hutt Vally District Health Board, with a camera for recording purpose. The ADOS-2 will be administered for 60 min by the investigator. Information sheet and consent form will be given to the family in the previous session. Phone calls will be made by the investigator to make sure parents/caregiver understand the process and clarify any doubts. On the ADOS assessment day a blank paper will be given to parents/caregiver to make notes about their likes and dislikes while watching the assessment. Following the assessment a questionnaire will be given to parents/caregiver to complete at home and bring it back in the next appointment. Phone calls will be made during this time to help parents/caregiver complete the questionnaire and clarify doubts. All the completed questionnaires will be returned to the sealed box during the next appointment. The box will be opened for analysis at the end of the study. This process will be followed for both Group A and Group B. Grouping is done on the basis of which Module to be used and not for comparion purpose.

Group A: In this group parents/caregiver will be allowed to sit and watch in the same room where assessment takes place. ADOS module 1 and 2 will be administered for this group. Module 1 of the ADOS-2 is designed for children aged 31 months and older who have speech abilities ranging from no speech at all up to and including the use of simple phrase (three word sentences). The ADOS-2, Module 1, includes activities such as free play, bubbles and balloon play, functional and symbolic play, pretend birthday party, and snack time.
ADOS module 2 is designed for use for children of any age who use phrase speech but who are not yet truly verbally fluent and for whom the toys and materials are appropriate. The ADOS-2, Module Two, includes activities such as free play, bubbles, pretend play, conversation, description of a picture, and storytelling.

Group B: in this group parents/caregiver will be asked to sit and watch from the adjacent room. This room is provided with a two-way mirror window and speaker. ADOS module 3 and 4 will be administered. ADOS-2, Module 3 is for children and adolescents with fluent speech. It includes a series of semi-structured tasks of high interest and includes activities such as storytelling, a demonstration task, make-believe play, and some questions on feelings and emotions. ADOS-2 Module 4 is designed for use with older adolescents and adults who have "fluent" language skills and who have some levels of independence in terms of making everyday choices. it includes a series of semi structured tasks like construction task, telling story from book, description of a picture, conversation and reporting, creating story, demonstration of a routine task and some questions on emotions, feeling of loneliness, friendship and marriage.

Participants depending on their age and language skills will be administered either Module 1, 2, 3 or Module 4. As the administration of Module 1 and 2 are similar and require parents to sit and observe in the same room they are grouped in one group called Group A. Module 3 and 4 administration is same and require parents to sit outside the assessment room they are grouped under another group called Group B.
Intervention code [1] 321304 0
Diagnosis / Prognosis
Comparator / control treatment
No Control Group
Group A and Group B are just two different groups where the ADOS administration is different. no one is control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328433 0
Cultural appropriateness as assessed by the Questionnaire designed specifically for the study
Timepoint [1] 328433 0
the questionnaire will be returned within one week of intervention delivery. for that client.
Secondary outcome [1] 398997 0
nil
Timepoint [1] 398997 0
nil

Eligibility
Key inclusion criteria
Families identifying themselves as NZ Maori
Referred to Child Development Service (CDS), Hutt Valley for developmental assessment
NZ Maori families waiting for ADOS-2 administration
Children with age range from 2-16 years.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Families not identifying as NZ Maori
Families not referred to CDS developmental assessment team
Families not wanting ADOS-2 assessment
Where ADOS assessment not indicated

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
30/11/2021
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 24012 0
New Zealand
State/province [1] 24012 0
Wellington

Funding & Sponsors
Funding source category [1] 309213 0
Government body
Name [1] 309213 0
Child Development Service, Hutt Valley District Health Board
Country [1] 309213 0
New Zealand
Primary sponsor type
Government body
Name
Hutt Valley District Health Board
Address
638 High Street, Boulcott, Lower Hutt 5010
Country
New Zealand
Secondary sponsor category [1] 310175 0
None
Name [1] 310175 0
Address [1] 310175 0
Country [1] 310175 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309065 0
NZ Ethics Review Manager, Health and Disability Ethics Committee, Ministry of Health, NZ
Ethics committee address [1] 309065 0
Ethics committee country [1] 309065 0
New Zealand
Date submitted for ethics approval [1] 309065 0
02/08/2021
Approval date [1] 309065 0
Ethics approval number [1] 309065 0

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

Contacts
Principal investigator
Name 112846 0
Mrs Meenakshi Panda
Address 112846 0
Child Development Service, Hutt Valley District Health Board
Private Bag 31-907, Lower Hutt 5010
Country 112846 0
New Zealand
Phone 112846 0
+64273568275
Fax 112846 0
Email 112846 0
[email protected]
Contact person for public queries
Name 112847 0
Meenakshi Panda
Address 112847 0
Child Development Service, Hutt Valley District Health Board
Private Bag 31-907, Lower Hutt 5010
Country 112847 0
New Zealand
Phone 112847 0
+64273568275
Fax 112847 0
Email 112847 0
[email protected]
Contact person for scientific queries
Name 112848 0
Meenakshi Panda
Address 112848 0
Child Development Service, Hutt Valley District Health Board
Private Bag 31-907, Lower Hutt 5010
Country 112848 0
New Zealand
Phone 112848 0
+64273568275
Fax 112848 0
Email 112848 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12994Study protocol    382447-(Uploaded-23-09-2021-13-00-22)-Study-related document.docx
13339Informed consent form    382447-(Uploaded-23-09-2021-13-00-55)-Study-related document.doc



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.