Preventing preschool externalising behaviour problems: A cluster controlled trial evaluating the 'Toddlers Without Tears' parenting program delivered at age 8-15 months

ISRCTN	ISRCTN77531789
DOI	https://doi.org/10.1186/ISRCTN77531789
Protocol serial number	ACTRN12606000239561
Sponsor	Murdoch Children's Research Institute (Australia)
Funders	Philanthropic Organisation (Australia), William Buckland Foundation (Australia), Telstra Community Development Fund (Australia)

Submission date: 06/09/2004
Registration date: 04/11/2004
Last edited: 26/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Harriet Hiscock
Scientific

Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia

Phone	+61 (0)3 9345 6150
Email	harriet.hiscock@rch.org.au

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TWT - Toddlers Without Tears
Study objectives	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(s)	Ethics approval received from the Ethics in Human Research Committee (EHRC) (ref: 24020A)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	734
Key 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.
Key exclusion criteria	Parents with insufficient English to attend a parenting group and complete brief written questionnaires.
Date of first enrolment	01/12/2001
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

Australia

Study participating centre

Centre for Community Child Health

Melbourne
3052
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/02/2008		Yes	No
Results article	results	01/03/2010		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes