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ISRCTN
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ISRCTN61137690
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ClinicalTrials.gov identifier
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Public title
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Preventing mental health problems in children
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Scientific title
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Preventing mental health problems in children: a population-based cluster controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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This population-level randomised control trial aims to prevent behavioural and emotional problems from developing in pre-school children. The study has three arms: (A) combined universal-targeted approach; (B) targeted approach; and (C) usual care. We hypothesise that:
1. Each of the combined universal-targeted approach (A) and the targeted only approach (B) will be more effective and have greater population reach than current primary care services (C)
2. Uptake of the targeted prevention component for families where the child is at "high risk" of behavioural problems will be greater under the combined universal-targeted approach (A) than under the targeted only approach (B)
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Lay summary
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Ethics approval
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Royal Children's Hospital Melbourne Ethics and Research Board approved on the 17th of June 2010 (ref: 29144A)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Child externalising and internalising problems
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Participants - inclusion criteria
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Eligible participants are parents (primarily mothers) of 8 month old babies in 9 Melbourne local government areas. Parents will be invited to join the study between August and October 2010. We expect an even distribution of girls and boys in the study.
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Participants - exclusion criteria
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1. Parents with insufficient English to participate
2. Parents with babies with a major health condition
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Anticipated start date
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01/08/2010
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Anticipated end date
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30/09/2015
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use ms Kate Lycett [kate.lycett@mcri.edu.au] to request a patient information sheet
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Target number of participants
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Target sample size is 1475
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Interventions
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Arm A: All families in this group will be offered a parenting program (universal approach). This involves attending a parenting session when their child is 15, 18 and 24 months old. If at about 2 years of age a child is having behaviour or emotional difficulties or a family feels stressed, a one-on-one family support program (targeted approach) will also be offered.
Arm B: Some families in this group will be offered one-on-one family support (targeted approach). Families will be offered this service if their child is having behaviour or emotional difficulties at about age 2 or if the family feels stressed.
Arm C: Families in this group will only be offered ‘usual care’ by their maternal child health nurse
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Primary outcome measure(s)
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Child externalising and internalising diagnoses/symptoms and a measure of parent behaviour (nurturing/harsh discipline) at ages 3, 4 and 5.
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Secondary outcome measure(s)
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Parenting practices, parent mental health, and economic evaluation at ages 3, 4 and 5.
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Sources of funding
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1. National Health and Medical Research Council (NHMRC) (Australia) (ref: 546525)
2. Department of Human Services (Australia) - Mental Health
3. Department of Human Services (Australia) - Primary Health
4. Municipal Associations of Victoria (Australia)
5. Department of Education and Early Childhood (Australia)
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Trial website
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Publications
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Contact name
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Dr
Harriet
Hiscock
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Address
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Centre for Community Child Health
Royal Children's Hospital Melbourne
Flemington Road
Parkville, Victoria
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City/town
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Melbourne
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Zip/Postcode
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3052
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Country
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Australia
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Email
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Harriet.Hiscock@rch.org.au
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Sponsor
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National Health and Medical Research Council (NHMRC) (Australia)
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Address
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Level 1, 16 Marcus Clarke Street
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City/town
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Canberra
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Zip/Postcode
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2601
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Country
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Australia
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Sponsor website:
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http://www.nhmrc.gov.au/
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Date applied
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20/04/2010
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Last edited
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29/06/2010
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Date ISRCTN assigned
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29/06/2010
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