Condition category
Mental and Behavioural Disorders
Date applied
06/09/2004
Date assigned
04/11/2004
Last edited
26/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.rch.org.au/emplibrary/ccch/Todd_tears.pdf

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

  1. 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.

  2. 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.

Additional files

Editorial Notes