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ISRCTN
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ISRCTN77531789
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ClinicalTrials.gov identifier
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Public title
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Preventing preschool externalising behaviour problems: A cluster controlled trial evaluating the 'Toddlers Without Tears' parenting program delivered at age 8-15 months
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Scientific title
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Acronym
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TWT - Toddlers Without Tears
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Serial number at source
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ACTRN12606000239561
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Study hypothesis
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Preschool child externalising behaviour problems including aggression, opposition and hyperactivity.
1. At age 18 months:
1.1. Decreased incidence of externalising behaviours
1.2. Decreased prevalence of harsh and abusive parenting
1.3. Increased prevalence of warm and developmentally appropriate parenting
1.4. Decreased prevalence of maternal depression/anxiety
2. At age 24 months:
2.1. Sustained improvement in child behaviour, parenting and maternal wellbeing
3. An increase in knowledge, competency and confidence of Maternal and Child Health nurses in delivering anticipatory guidance for behaviour problems in young toddlers
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Lay summary
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Ethics approval
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Ethics approval received from the Ethics in Human Research Committee (EHRC) (ref: 24020A)
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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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Behavioural disorders
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Participants - inclusion criteria
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Eligible participants were parents of children aged 6 months attending community well-child clinics across 6 Melbourne local government areas during August/September 2004. Families were recruited from a broad sociodemographic sample.
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Participants - exclusion criteria
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Parents with insufficient English to attend a parenting group and complete brief written questionnaires.
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Anticipated start date
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01/12/2001
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Anticipated end date
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30/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Target sample size 370. Recruitment status achieved n = 734
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Interventions
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Cluster randomised controlled trial, cluster at the level of the well-child centre. Masking occurred at randomisation, with group allocation concealed from researchers and participants until allocation was complete.
Arm A: Parenting program (one individual 15-minute and two 2-hour group sessions) about normal child development, ways to encourage desirable behaviour and ways to manage misbehaviour in toddlers. Strategies derived from systematic reviews of parenting programs for treating established child externalising behaviour problems. Program delivered by maternal and child health nurses and co-facilitated by parenting experts.
Arm B: Usual care provided by nurses at well-child visits (active control)
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Primary outcome measure(s)
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Primary outcome 1: Parent-reported child behaviour problems on the Child Behaviour Checklist (Achenbach & Rescorla, 2000). Measured at 18 months, 24 months and 3 years.
Primary outcome 2: Parent-reported parenting practices on the Parent Behaviour Checklist (subscales: developmental expectations, nurturance, harsh discipline) (Fox, 1994). Measured at 18 months, 24 months and 3 years.
Primary outcome 3: Parent-reported mental health on the Depression Anxiety Stress Scales (Lovibond & Lovibond, 1995). Measured at 18 months, 24 months and 3 years.
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Secondary outcome measure(s)
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Economic evaluation (cost consequences) of cost of delivering the intervention and costs of other sevrices used by families for either the child's behaviour and/or the mother's mental health.
Timepoint: At 18, 24 and 36 months.
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Sources of funding
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1. Philanthropic Organisation (Australia)
2. William Buckland Foundation (Australia)
3. Telstra Community Development Fund (Australia)
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Trial website
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http://www.rch.org.au/emplibrary/ccch/Todd_tears.pdf
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Publications
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1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18244958
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19847011
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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
Flemington Road
Parkville
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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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Tel
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+61 (0)3 9345 6150
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Fax
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+61 (0)3 9345 5900
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Email
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harriet.hiscock@rch.org.au
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Sponsor
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Murdoch Children's Research Institute (Australia)
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Address
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Royal Children's Hospital
Flemington Road
Parkville
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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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Tel
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+61 (0)3 8341 6211
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Fax
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+61 (0)3 9348 1391
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Email
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julia.malone@mcri.edu.au
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Date applied
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06/09/2004
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Last edited
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26/10/2009
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Date ISRCTN assigned
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04/11/2004
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