Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000098538
Ethics application status
Approved
Date submitted
15/12/2023
Date registered
2/02/2024
Date last updated
26/08/2024
Date data sharing statement initially provided
2/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the Growing Minds Check-in for parents (GMCI-P) on parents/caregivers seeking help for child mental health
Scientific title
The effect of the Growing Minds Check-in for parents (GMCI-P) on parents/caregivers seeking help for child mental health
Secondary ID [1] 311193 0
NA
Universal Trial Number (UTN)
Trial acronym
GMCI-P RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child mental health 332372 0
Condition category
Condition code
Mental Health 329081 329081 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are parents/caregivers (henceforth referred to as ‘parents’) of children aged from birth to 17 years, 6 months of age, who self-refer and would like to check-in on their child’s mental health (MH) or learn more about specific online evidence-based programs that could meet their child’s mental health and wellbeing needs. The GMCI-P will take approximately 15 minutes to complete in one sitting, but if parents need to attend to other matters, they are able to return to the GMCI-P and complete the questions at a later time. Commencement and completion of the GMCI-P is entirely at parent's discretion and is to be completed in a private location of their choosing. The GMCI-P website and tool is hosted by Netfront, who adhere to the NHMRC and University of Sydney privacy and data security recommendations. They also provide the ability to set up a family profile in order to track progress through the GMCI-P, to return to use the tool in the future and see prior recommendations, and provide website analytics.

The aim of this research is to evaluate the efficacy, acceptability and cost-effectiveness of the GMCI-P, a new, brief, online self-directed check-in (or screening) and referral tool for parents/caregivers of children aged birth to 18 years.

We will conduct an RCT with 500 families. The study will randomise parents to receive the GMCI-P immediately versus a Waitlist control (WLC) group, and the GMCI-P intervention group will be followed at post-intervention, three-month follow-up and six-month follow-up. In addition, the first 50 participants in the intervention group will be assessed at post in an optional qualitative interview. The Waitlist group will receive the GMCI-P after the three-month follow-up and will not be followed up further.

The aim of this research is to examine the efficacy and acceptability of the GMCI-P in increasing the likelihood that children at risk of MH problems will be identified and to increase parent help-seeking for child mental health by connecting to evidence-based online programs (via the recommendations provided). We will also investigate further help-seeking behaviour (for those parents currently seeking help for their child’s MH and wellbeing), child MH symptoms, parents’ intentions to seek help or access a program (help-seeking intentions measured at 3mfu), parenting, parent wellbeing, parenting self-efficacy, knowledge about where to access support to strengthen their child’s MH and wellbeing if needed, cost-effectiveness, parents’ satisfaction with help-sought, and the acceptability (as determined by parents’ responses to satisfaction and perceived usefulness questions at post-intervention questionnaire). We will also explore possible iatrogenic effects from the use of the GMCI-P (namely, increases in help-seeking stigma and parental anxiety about child mental health and wellbeing). We will further examine acceptability and possible iatrogenic effects qualitatively, through a post-intervention interview for a sub-sample of the intervention group only. Predictors and moderators to be examined include socio-demographic variables, prior child MH diagnosis, service type, dosage of service and perceived barriers to help-seeking.

The GMCI-P contains the five primary components: 1) subjective questions on parents’ perceptions and concerns about their child’s MH and development, and 2) objective questions, including validated measures of child MH for parents (e.g., Pediatric Symptom Checklist) to complete online at their own pace. The GMCI-P questions have been developed based on a review of the current evidence on UMHS, and in collaboration with an expert Advisory Group and the end-users of the system (e.g., parents/caregivers); 3) automatically generated feedback to parents based on their response to questions. Using the validated measures of child MH appropriate to the child’s age, children’s aggregate scores will be categorised into a relative risk profile, with scores below the specified clinical cut off considered “low risk” (i.e., low range) and those scores that fall above the clinical cut off considered “high risk” (i.e., at risk). Parents will be prompted to save their feedback and recommendations as a PDF and share it with to their GP, or if they feel they need more than the online recommendations, directed to the ‘Additional Resources and Help’ page with links to other services, supports and resources; 4) if scores are within the high risk range for any of the objective validated measures or a parent indicates a concern they would like help for on subjective questions, they will receive a matched recommendation to child’s age and identified needs for an online evidence-based program and information source. If scores are within the low-risk range for any objective validated measure, they will receive universal recommendations for programs/information that can help increase general parent knowledge and skills. All recommendations will include descriptions of the program or resource that identify the focus, the evidence supporting it, the cost (if applicable), and the length. Those parents who identify multiple concerns may receive multiple recommendations; and 5) post-intervention questions which ask parents evaluate acceptability of the intervention.

All parents will also be reminded that the GMCI-P is not designed to provide a comprehensive assessment or diagnosis of child mental health and well-being, and therefore may not identify the issues that would be identified by a full clinical assessment conducted by a health practitioner, and those seeking a mental health diagnosis should speak to their GP about referral pathways. Parents will be guided to save their feedback and recommendations as a PDF and share it with/talk to their GP or other health professional if desired. An example of matched recommendations made for a child with high anxiety symptoms include an overview of 1) what they selected they wanted help with (e.g. anxiety symptoms), 2) the range their scores fell within on our objective measures (i,e,, age dependent version of the pediatric symptom checklist). In this example, we would provide information about the following online programs: 1) Cool Kids Online, 2) Brave Program, 3) Fearless Triple P, 4) Parent Works, and provide links to relevant sections of the Raising Children's Network.
Intervention code [1] 327641 0
Early detection / Screening
Comparator / control treatment
Parents randomly allocated to the waitlist control group will wait for 12 weeks (three-months) before receiving the online GMCI-P intervention after completion of three-month follow up questions). The waitlist group will be able to access their usual services and support during the waiting period. This means that if they were previously receiving or seeking help from any medical or mental health provider, they are encouraged to continue with this.
Control group
Active

Outcomes
Primary outcome [1] 336898 0
Parent help-seeking behaviour for child mental health and wellbeing (this could include seeing a health professional, or an online program/course, or a parenting program).
Timepoint [1] 336898 0
The help-seeking behaviour question will be administered at baseline (intervention/waitlist control (WLC) group), three-month follow-up (intervention group/waitlist group) and six-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion. The primary time-point for this study is three-month follow up.
Secondary outcome [1] 430052 0
For children aged 0 to 23 months, irritability
Timepoint [1] 430052 0
The BPSC Irritability subscale will be administered at the baseline (intervention/WLC group), at 3-month follow-up (intervention group/WLC group), and at 6-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [2] 430053 0
For children aged 0 to 23 months, flexibility
Timepoint [2] 430053 0
The BPSC Inflexibility subscale will be administered at baseline (intervention/WLC group), at 3-month follow-up (intervention group/WLC group), and at 6-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [3] 430054 0
For children aged 0 to 23 months, difficulty with schedules and routines
Timepoint [3] 430054 0
The BPSC Difficulty with Routines subscale will be administered at baseline (intervention/WLC group), at 3-month follow-up (intervention group/WLC group), and at 6-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [4] 430055 0
For children aged 0 to 23 months, total social and emotional symptoms
Timepoint [4] 430055 0
The BPSC will be administered at baseline (intervention/WLC group), at 3-month follow-up (intervention group/WLC group), and at 6-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [5] 430056 0
For children aged 2 years (24 months) up to 4 years (47 months), children’s total difficulties with social, emotional and behavioural wellbeing
Timepoint [5] 430056 0
The PPSC will be administered at baseline (intervention/WLC group), at 3-month follow-up (intervention group/waitlist group), and at 6-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [6] 430057 0
Emotional wellbeing (For children aged 4 years to 18 years)
Timepoint [6] 430057 0
The PSC-17 Internalising subscale will be administered at baseline (intervention/WLC group), at 3-month follow-up (intervention group/WLC group), and at 6-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [7] 430058 0
Behavioural wellbeing (For children aged 4 years to 18 years)
Timepoint [7] 430058 0
The PSC-17 Externalising subscale will be administered at baseline (intervention/WLC group), at 3-month follow-up (intervention group/WLC group), and at 6-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [8] 430059 0
Attention and activity (For children aged 4 years to 18 years)
Timepoint [8] 430059 0
The PSC-17 Attention subscale will be administered at baseline (intervention/WLC group), at 3-month follow-up (intervention group/WLC group), and at 6-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [9] 430060 0
total difficulties with social, emotional and behavioural wellbeing (For children aged 4 years to 18 years)
Timepoint [9] 430060 0
The PSC-17 will be administered at baseline (intervention/WLC group), at 3-month follow-up (intervention group/WLC group), and at 6-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [10] 430061 0
Parent help-seeking intentions for child mental health and wellbeing
Timepoint [10] 430061 0
The adapted help-seeking intentions questions will be administered at baseline (intervention/WLC group), post-intervention (intervention group only) three-month follow-up (intervention group/WLC group) and six-month follow-up (intervention group only). Post-intervention questionnaire occurs immediately after GMCI-P completion, and three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [11] 430063 0
Parenting
Timepoint [11] 430063 0
The PS-13 will be administered at baseline (intervention/WLC group), three-month follow-up (intervention/WLC group) and six-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [12] 430064 0
Parent wellbeing
Timepoint [12] 430064 0
The K6 will be administered at baseline (intervention/WLC group), three-month follow-up (intervention/WLC group) and six-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [13] 430065 0
Parenting self-efficacy
Timepoint [13] 430065 0
The Efficacy subscale of the PSOC will be administered at baseline (intervention/WLC group), three-month follow-up (intervention/WLC group) and six-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [14] 430066 0
Parent Knowledge about where to access support
Timepoint [14] 430066 0
The knowledge question will be administered at baseline (intervention/WLC group), post-intervention (intervention group only) three-month follow-up (intervention group/WLC group) and six-month follow-up (intervention group only). Post-intervention questionnaire occurs immediately after GMCI-P completion, and three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [15] 430067 0
Satisfaction with help-sought post-intervention
Timepoint [15] 430067 0
The satisfaction with help-sought question will be administered at baseline (intervention/WLC group), three-month follow-up (intervention/WLC group) and six-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [16] 430068 0
Satisfaction (component of acceptability) with the GMCI-P
Timepoint [16] 430068 0
The satisfaction questions will be administered to all participants in the intervention group only immediately following the completion of the GMCI-P intervention via online questions (post-intervention questionnaire), as well as via qualitative questions given to a subset of the intervention groups (post-intervention interview).
Secondary outcome [17] 430069 0
Perceived usefulness (component of acceptability) of the GMCI-P
Timepoint [17] 430069 0
The perceived usefulness questions will be administered to all participants in the intervention group only immediately following the completion of the GMCI-P intervention via online questions (post-intervention questionnaire), as well as via qualitative questions given to a subset of the intervention groups (post-intervention interview).
Secondary outcome [18] 430070 0
The health economic evaluation of the cost effectiveness of the GMCI-P
Timepoint [18] 430070 0
The CHU-9D and resource use questions will be administered at baseline (intervention/WLC group), three-month follow-up (intervention/ WLC group) and six-month follow-up (intervention group only). For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [19] 430071 0
Help-seeking stigma
Timepoint [19] 430071 0
The stigmatization scale of the PATSPI will be administered at baseline (intervention/WLC group), post-intervention (intervention group only), three-month follow-up (intervention/WLC group) and six-month follow-up (intervention group only). For the intervention group, post-intervention questions occur immediately after completion of the intervention. For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.
Secondary outcome [20] 430072 0
Parents’ anxiety about their child’s mental health and wellbeing
Timepoint [20] 430072 0
The item assessing parent anxiety about their child’s mental health and wellbeing will be administered at baseline (intervention/WLC group), post-intervention (intervention group only) three-month follow-up (intervention/WLC group) and six-month follow-up (intervention group only). For the intervention group, post-intervention questions occur immediately after completion of the intervention. For the intervention group, three-month follow-up and 6-month follow-up occur 3 months and 6 months after intervention completion respectively. For the WLC group, three-month follow up occurs 12 weeks after baseline questionnaire completion.

Eligibility
Key inclusion criteria
Inclusion criteria include: 1. Adult (18 years and above) parents/caregivers of children aged from birth to 17 years, 6 months (only one caregiver and one child per family); 2. Parents who are comfortable reading and completing questionnaires in English; 3. Parents who have reliable access to internet either on mobile device, tablet, laptop, or computer; 4. Parents who live with their child-of-interest at least some of the week.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to treatment condition will be concealed to the researchers by using a central randomisation procedure on the trial’s REDCap system: Once the participant has provided informed consent (i.e., signed the consent form) following the recruitment and screening interview, the research team member will initiate random allocation to either the online intervention (GMCI-P) or waitlist control using the in-built randomization feature on REDCap. This procedure will ensure concealment of treatment allocation as well as an audit trail for confirming allocation. Participants will then be directed to complete a group specific baseline assessment. Once participants have completed the baseline assessment, they will be notified of the allocated group via email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation sequence will be generated using Robust Randomisation App (RRApp; Tu & Benn, 2018), which is an online tool. This sequence will be imported into the trial’s REDCap system
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations using G*Power show that we will be able to detect an increase in help-seeking behaviour (noting that at least 40% will already be engaged in services) of 15% in the intervention relative to the control group at follow-up using a logistic multiple regression model with a total sample size of N= 308 (n =154 in intervention and control; power=0.8 at alpha=.05). This estimated change in help-seeking is consistent with previous research investigating changes in help-seeking behaviour has identified a 15% difference in change in help-seeking at 6-month post-intervention follow-up (Wiljer et al., 2020). A sample size of N = 440 accounts for 30% attrition [308/(1-0.30)=440].

Analyses will follow Consolidated Standards of Reporting Trials (CONSORT; Schulz et al., 2010) for longitudinal analyses. Statistical analyses will be conducted in SPSS. Initial comparisons of the intervention and waitlist control groups at baseline will be performed using ANOVAs and chi-square tests of independence. This is to ensure adequate randomisation in that there were no significant differences between demographic variables or outcome variables prior to the intervention. This also includes chi-square tests for significant differences in rates of attrition between intervention and waitlist control group.

For the primary outcome, help-seeking behaviour, intervention effects will be measured using a logistic regression, with group as a between-subjects factor (intervention, waitlist control) and timepoint (pre-, three-month follow up) as a within-subjects factor. Differences at baseline and on current help-seeking behaviour (parent-report yes/no to question: are you currently seeking or receiving help from for [child_name]’s wellbeing (this could include seeing a health professional, an online program/course or parenting program) will be used as covariates in the analyses to control for any differences, and therefore reduce error. Regressions also included an interaction term to determine whether changes in help-seeking behaviour were moderated by current help-seeking behaviour. A separate analysis will be run including identified child MH and wellbeing concerns as a covariate, and including an interaction term to determine whether changes in help-seeking behaviour was moderated by identified child MH and wellbeing concern(s). Cohen’s d will be used to measure the effect size in order to report the magnitude of relationships.

For secondary outcome variables (namely: MH and wellbeing, help-seeking intentions measured at 3mfu, parenting, parent wellbeing, parent self-efficacy, knowledge of where to access support to strengthen their child’s MH and wellbeing if needed measured at 3mfu), effects will be measured using repeated measures ANOVAs, with group as a between-subjects factor (intervention, waitlist control) and timepoint (pre-, three-month follow up) as a within-subjects factor. Differences at baseline will be used as covariates in the analyses to control for any differences and therefore reduce error. Cohen’s d will be used to measure the effect size in order to report the magnitude of relationships.

A repeated measures ANOVAs with timepoint (three-month follow up, 6-month follow-up) as a within-subjects factor will be conducted to assess change in help-seeking behaviour for the intervention group. A further set of repeated measures ANOVAs with timepoint (pre, three-month follow up, 6-month follow up) as within subjective factor will be conducted to assess change in all outcomes across the three timepoints for the intervention group.

For intervention group participants only, for acceptability (secondary outcome), help-seeking intentions (secondary outcome) and knowledge of where to access support to strengthen their child’s MH and wellbeing if needed, intervention effects will be measured using a series of ANOVAs, with timepoint (pre-, post-intervention) as a within-subjects factor. Moreover, for intervention group participants only, for satisfaction with help-sought for child MH and wellbeing (secondary outcome), intervention effects will be measured using a series of ANOVAs, with timepoint (pre-, three-month follow up) as a within-subjects factor. For all of these analyses, differences at baseline will be used as covariates in the analyses to control for any differences and therefore reduce error. Cohen’s d will be used to measure the effect size in order to report the magnitude of relationships. Means and standard deviations will also be reported for acceptability.

For the secondary outcome variables, help-seeking stigma and parental anxiety (i.e., iatrogenic effects), intervention effects will be measured using repeated measures ANOVAs, with timepoint (pre-, post-intervention, three-month follow up, six-month follow up) as a within-subjects factor. Differences at baseline will be used as covariates in the analyses to control for any differences and therefore reduce error. Cohen’s d will be used to measure the effect size in order to report the magnitude of relationships.

Depending on amount of missing data, we will perform an intention-to-treat (ITT) analyses, such that participants’ data will be analysed according to the group they were originally randomly assigned to. That is, if a waitlist control participant completed the intervention during the waitlist period, they will be analysed as a control participant. If an intervention participant did not complete the intervention, they will still be analysed as an intervention group participant.

Finally, we will conduct structural equation models (SEM) to identify variables that represent processes and mechanisms that contribute to, or hinder, change in help-seeking behaviour (i.e. predictors and/or moderators).

Lastly, the within trial economic evaluation will be undertaken from health sector and societal perspectives. Outcomes utilised for the economic evaluation will include the primary and secondary outcomes in addition to quality adjusted life years (QALYs). The Australian value set for the CHU-9D will be used to derive utility values at each time point. The utility values at each time point will then be used to calculate total QALYs for each participant using the area under the curve method. Standard economic evaluation techniques including incremental analysis of mean differences and bootstrapping to determine confidence intervals for incremental ratios will be used in the evaluation. Sensitivity analyses will be undertaken to determine how robust the results are to some of the analytical assumptions (for example, variation in utility algorithm used and unit costs).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/07/2024
Actual
22/07/2024
Date of last participant enrolment
Anticipated
17/03/2025
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
440
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315452 0
Government body
Name [1] 315452 0
National Health and Medical Research Council - Million Minds Mental Health Research Mission – The Medical Research Future Fund (MRFF)
Country [1] 315452 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 317524 0
None
Name [1] 317524 0
Address [1] 317524 0
Country [1] 317524 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314362 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 314362 0
Ethics committee country [1] 314362 0
Australia
Date submitted for ethics approval [1] 314362 0
06/04/2023
Approval date [1] 314362 0
02/08/2023
Ethics approval number [1] 314362 0
2023/350

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

Contacts
Principal investigator
Name 131318 0
Prof Mark Dadds
Address 131318 0
The University of Sydney Child Behaviour Research Clinic Level 1, 97 Church Street, Camperdown 2050
Country 131318 0
Australia
Phone 131318 0
+61 2 9114 4321
Fax 131318 0
Email 131318 0
[email protected]
Contact person for public queries
Name 131319 0
Jaimie Northam
Address 131319 0
The University of Sydney Child Behaviour Research Clinic Level 1, 97 Church Street, Camperdown 2050
Country 131319 0
Australia
Phone 131319 0
+61 2 9114 4326
Fax 131319 0
Email 131319 0
[email protected]
Contact person for scientific queries
Name 131320 0
Jaimie Northam
Address 131320 0
The University of Sydney Child Behaviour Research Clinic Level 1, 97 Church Street, Camperdown 2050
Country 131320 0
Australia
Phone 131320 0
+61 2 9114 4326
Fax 131320 0
Email 131320 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?

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.