Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Harriet Hiscock
ORCID ID
Contact details
Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 9345 6150
harriet.hiscock@rch.org.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ACTRN12606000239561
Study information
Scientific title
Acronym
TWT - Toddlers Without Tears
Study hypothesis
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
Ethics approval
Ethics approval received from the Ethics in Human Research Committee (EHRC) (ref: 24020A)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Behavioural disorders
Intervention
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)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
01/12/2001
Overall trial end date
30/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Target sample size 370. Recruitment status achieved n = 734
Participant exclusion criteria
Parents with insufficient English to attend a parenting group and complete brief written questionnaires.
Recruitment start date
01/12/2001
Recruitment end date
30/06/2006
Locations
Countries of recruitment
Australia
Trial participating centre
Centre for Community Child Health
Melbourne
3052
Australia
Sponsor information
Organisation
Murdoch Children's Research Institute (Australia)
Sponsor details
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 8341 6211
julia.malone@mcri.edu.au
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Philanthropic Organisation (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
William Buckland Foundation (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Telstra Community Development Fund (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18244958
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19847011
Publication citations
-
Results
Hiscock H, Bayer JK, Price A, Ukoumunne OC, Rogers S, Wake M, Universal parenting programme to prevent early childhood behavioural problems: cluster randomised trial., BMJ, 2008, 336, 7639, 318-321, doi: 10.1136/bmj.39451.609676.AE.
-
Results
Bayer JK, Hiscock H, Ukoumunne OC, Scalzo K, Wake M, Three-year-old outcomes of a brief universal parenting intervention to prevent behaviour problems: randomised controlled trial., Arch. Dis. Child., 2010, 95, 3, 187-192, doi: 10.1136/adc.2009.168302.