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Trial registered on ANZCTR
Registration number
ACTRN12624000879561
Ethics application status
Approved
Date submitted
2/07/2024
Date registered
18/07/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
18/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A feasibility pilot of the Tuning in to Toddlers program for parents of young children diagnosed with autism
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Scientific title
Evaluating the acceptability and feasibility of the Tuning in to Toddlers parent emotion coaching program for supporting emotional development in young children diagnosed with autism
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Secondary ID [1]
312442
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autism
334268
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Condition category
Condition code
Mental Health
330930
330930
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0
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Autistic spectrum disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention, 'Tuning in to Toddlers’, studied in this trial is a developmentally adapted version of the 'Tuning in to Kids’ program, an emotion-focused parenting program for children with emotional and behavioural difficulties. The program is based on emotional socialisation theory, integrating attachment, mindfulness, and neurobiological theories and concepts. The Tuning in to Toddlers program has previously been developed and trialled for non-autistic toddlers (ACTRN12615000962538).
The intervention is parent-mediated; that is, intervention where parents are the primary agent of change for children' development. Children are not participants in this intervention; rather, parents/caregivers are the participants, with therapists providing strategies and tools for parents to implement in their everyday environments.
The intervention is manualised, with all sessions including activities to support parental understanding and regulation of their own and their child's emotions. Within the program are five steps of emotion coaching, which provides parents with a model for responding to their child's emotions and supports parental understanding of how to: (a) be aware of their child's low-intensity emotions; (b) view their child's emotions as a time for intimacy and teaching; (c) communicate understanding and acceptance towards their child's emotions; (d) name the feeling; and (e) provide comfort, assist with choices, set limits, provide distraction, or problem solve. The program is psychoeducational, delivered through watching videos, discussion about parental beliefs and experiences of emotions, role-plays, and home activities - all of which facilitate parents' ability to engage in emotion coaching. Home activities are optional and may include using worksheets to help facilitate understanding of the program content.
The intervention will be delivered as eight weekly, one-hour sessions, delivered one-on-one to parents, by community-based clinical professionals with sufficient knowledge and experience working with autistic children and families, delivered face-to-face (in a community-based clinic located in Perth) or online via video conferencing software. Two one-hour sessions, delivered at one and two-months post-program, will also be offered as optional 'booster' sessions.
Intervention fidelity will be assessed through a checklist completed by the clinician at the end of each session. Adherence to the program will be assessed through participant completion of each session and attrition.
Feedback from participants on the program acceptability will be assessed through interviews at the end of the program. Interviews will be semi-structured, using a study-specific interview guide. Interviews will be conducted by a member of the research team not involved in providing the program, lasting between 30 minutes to an hour, and will be audio recorded for transcription purposes.
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Intervention code [1]
328948
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Behaviour
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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Feasibility will be assessed by: (i) recruitment rates, measured via study recruitment logging forms, (ii) session attendance from participant attendance records, and (iii) attrition and reasons for withdrawal, measured through withdrawal logging forms and drop-out rates per timepoint.
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Timepoint [1]
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Recruitment rates, session attendance, and attrition will be assessed upon conclusion of the study.
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Primary outcome [2]
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Acceptability
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Assessment method [2]
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Acceptability will be measured through weekly session ratings (5-point Likert scale) and post-program feedback semi-structured interviews.
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Timepoint [2]
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Individual session ratings will be collected at the end of each weekly session. Interviews will be completed at follow-up (four months post-baseline).
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Secondary outcome [1]
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Parent Emotional Style Questionnaire
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Assessment method [1]
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The Parent Emotional Style Questionnaire (PESQ; 21 items; Havinghurst et al., 2010) is an adaptation of the Maternal Emotional Style Questionnaire (MESQ; 14 items; Lagacé-Séguin & Coplan, 2005). Additional items added to the MESQ examine parents’ responses to children’s fears and worries. Subscales are calculated on emotion coaching, emotion dismissing, and empathy.
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Timepoint [1]
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Measured at baseline, two-months post-baseline, and four-months post-baseline
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Secondary outcome [2]
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Emotion Socialisation Questionnaire
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Assessment method [2]
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The Emotion Socialisation Questionnaire was developed by Havighurst and Kehoe (2023, Unpublished manuscript: The University of Melbourne). An emotion socialisation total score will be used.
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Timepoint [2]
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Measured at baseline, two-months post-baseline, and four-months post-baseline
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Secondary outcome [3]
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Coping with Toddlers Negative Emotions Scale
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Assessment method [3]
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The Coping with Toddlers Negative Emotions Scale (CTNES) measures parent emotion socialisation behaviours (Spinrad et al., 2004). Parents respond to 12 vignettes relating to child emotions and rate on a 7-point scale (from very unlikely to very likely) whether they would respond in seven possible ways, yielding seven subscales: Distress Reactions, Granting the Child’s Wish, Problem-Focused Reactions, Emotion-Focused Reactions, Expressive Encouragement, Punitive Reactions, and Minimising Reactions.
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Timepoint [3]
437272
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Measured at baseline, two-months post-baseline, and four-months post-baseline
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Secondary outcome [4]
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Difficulties In Emotion Regulation Scale
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Assessment method [4]
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The Difficulties In Emotion Regulation Scale is a 36-item questionnaire measuring emotion awareness and regulation (Gratz & Roemer, 2004). This measure assesses potential changes in parent’s ability to become more aware of and regulate their own emotions. Items are rated on a 5-point scale, with six subscales (emotional awareness, emotional non-acceptance, emotional clarity, capacity to undertake goal-directed behaviour, impulse control, access to regulation strategies).
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Timepoint [4]
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Measured at baseline, two-months post-baseline, and four-months post-baseline
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Secondary outcome [5]
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Parenting Sense of Confidence
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Assessment method [5]
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The Parenting Sense of Confidence (PSOC) questionnaire is a 17-item measure of
parents’ sense of efficacy in their parenting (Johnston & Mash, 1989), containing two subscales - satisfaction and efficacy.
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Timepoint [5]
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Measured at baseline, two-months post-baseline, and four-months post-baseline
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Secondary outcome [6]
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Autism Parent Stress Index
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Assessment method [6]
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The Autism Parent Stress Index is a 13-item measure of parenting stress specific to autism and co-occurring conditions related to autism, and will be used to measure changes associated
with the intervention that may impact parenting stress. A total parenting stress score will be used.
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Timepoint [6]
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Measured at baseline, two-months post-baseline, and four-months post-baseline
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Eligibility
Key inclusion criteria
Parent^ of a child:
(1) aged between 18 - 48 months of age;
(2) diagnosed with autism (autism, or autism spectrum disorder) or awaiting confirmation of an autism diagnosis (following diagnostic assessment);
(3) experiencing emotion regulation difficulties (parent-reported).
Parent:
(1) can attend most planned intervention sessions;
(2) can complete the program, questionnaires, and interview in English.
^'Parent' is an inclusive term, referring to anyone who takes a primary caregiving role for the child related to this study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(1) Unable to attend most planned intervention sessions;
(2) Any active court proceedings or special care arrangements; and
(3) Parental mental or physical health condition that causes significant distress and or impact on parenting and family life at the time of participation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
30/08/2024
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Actual
30/08/2024
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Date of last participant enrolment
Anticipated
2/06/2025
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Actual
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Date of last data collection
Anticipated
30/11/2025
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Actual
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Sample size
Target
20
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
316859
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Other
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Name [1]
316859
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CliniKids, The Kids Research Institute Australia - in-kind staff time and resources
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
316901
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University
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Name [2]
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University of Melbourne - in-kind staff time, provision of training, and resources
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Address [2]
316901
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Country [2]
316901
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Australia
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Primary sponsor type
Other
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Name
The Kids Research Institute Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319095
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Address [1]
319095
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Country [1]
319095
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315618
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The University of Western Australia Human Research Ethics Committee
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Ethics committee address [1]
315618
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http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO
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Ethics committee country [1]
315618
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Australia
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Date submitted for ethics approval [1]
315618
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30/04/2024
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Approval date [1]
315618
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26/06/2024
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Ethics approval number [1]
315618
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2024/ET000183
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Summary
Brief summary
Children diagnosed with autism can experience difficulties expressing and communicating their emotions, which can be linked to later mental health difficulties. There is evidence that a parent emotion coaching program, called Tuning in to Toddlers, can improve a parent's ability to respond to their child's emotions and impact child behaviours; however, it is unknown whether this program would be suitable for children diagnosed with autism. The purpose of this feasibility pilot is to understand whether it is feasible to deliver this program to families of very young autistic children and family's perspectives and acceptability of this program.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Gail Alvares
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Address
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CliniKids, The Kids Research Institute Australia
100 Roberts Road Subiaco WA 6008
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Country
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Australia
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Phone
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+61 8 6319 1698
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Gail Alvares
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Address
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CliniKids, The Kids Research Institute Australia
100 Roberts Road Subiaco WA 6008
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Country
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Australia
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Phone
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+61 8 6319 1698
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Gail Alvares
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Address
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CliniKids, The Kids Research Institute Australia
100 Roberts Road Subiaco WA 6008
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Country
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Australia
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Phone
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+61 8 6319 1698
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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