Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000239561
Ethics application status
Approved
Date submitted
25/05/2006
Date registered
15/06/2006
Date last updated
15/06/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing preschool behaviour problems: A community based, cluster-controlled trial.
Scientific title
Preventing preschool externalising behaviour problems: A cluster controlled trial evaluating the 'Toddlers Without Tears' parenting program delivered at age 8-15 months
Secondary ID [1] 269 0
International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN77531789
Universal Trial Number (UTN)
Trial acronym
TWT – Toddlers Without Tears
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preschool child externalising behaviour problems including aggression, opposition and hyperactivity 1216 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A - Intervention: Parenting program (one 15-minute session at the routine individual Maternal and Child Health (MCH) 8-month visit, and two 2-hour group sessions when the children are ages 12 and 15 months) that discuss normal toddler behaviour development, ways to encourage desirable behaviour, and ways to manage misbehaviour. Strategies were derived from systematic reviews of parenting programs for treating established child externalising behaviour problems. Programs delivered by Maternal and Child Health (MCH) Nurses and co-facilitated by parenting experts.
Intervention code [1] 1071 0
Prevention
Comparator / control treatment
Arm B - Control: Standard care provided by MCH Nurses at well child visits (active control) Families can attend free well child visits at 8, 12, 18 and 36 months of age where advice about development and management of established behaviour problems may be offered. There is no routine advice about prevention of behaviour problems.
Control group
Active

Outcomes
Primary outcome [1] 1777 0
Parent-reported child behaviour problems on the Child Behaviour Checklist (Achenbach & Rescorla, 2000)
Timepoint [1] 1777 0
Measured at 18 months, 24 months and 3 years
Primary outcome [2] 1778 0
Parent-reported parenting practices on the Parent Behaviour Checklist (subscales: developmental expectations, nurturance, harsh discipline) (Fox, 1994)
Timepoint [2] 1778 0
Measured at 18 months, 24 months and 3 years
Primary outcome [3] 1779 0
Parent-reported mental health on the Depression Anxiety Stress Scales (Lovibond & Lovibond, 1995)
Timepoint [3] 1779 0
Measured at 18 months, 24 months and 3 years
Secondary outcome [1] 3133 0
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 [1] 3133 0
At 18, 24 and 36 months.

Eligibility
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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents with insufficient English to attend a parenting group and complete brief written questionnaires.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This was a cluster randomised controlled trial, with cluster at the level of the well-child centre. After the study team had recruited all clusters, randomisation was carried out by an independent statistician who was unaware, when the decision was made that the family was eligible to take part, to which group the family would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerized sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1427 0
Commercial sector/Industry
Name [1] 1427 0
Telstra Community Development Fund
Country [1] 1427 0
Australia
Primary sponsor type
Individual
Name
Dr Harriet Hiscock
Address
Country
Secondary sponsor category [1] 1255 0
None
Name [1] 1255 0
Nil
Address [1] 1255 0
Country [1] 1255 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2802 0
Ethics in Human Research Committee, Royal Children’s Hospital
Ethics committee address [1] 2802 0
Ethics committee country [1] 2802 0
Australia
Date submitted for ethics approval [1] 2802 0
Approval date [1] 2802 0
Ethics approval number [1] 2802 0
EHRC 24020A

Summary
Brief summary
The study aims to prevent the development of child externalizing behaviour problems (eg aggression, oppositional defiance) by offering parents anticipatory guidance on how to effectively manage toddler behaviour. Up to 20% of Australian children aged 4 to 16 years experience significant behaviour problems and only ¼ of these receive professional help. Treating established problems is time and cost intensive and so a prevention approach is required. This community-based study will assess the effectiveness of a parenting program designed to promote warm and appropriate parenting, and to offer alternatives to harsh, punitive parenting (known to contribute to externalising problems). MCH nurses deliver the program. It is the first study of its kind in the world to offer a universal, primary health care preventive program for externalising behaviour problems.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35223 0
Address 35223 0
Country 35223 0
Phone 35223 0
Fax 35223 0
Email 35223 0
Contact person for public queries
Name 10260 0
Dr Harriet Hiscock
Address 10260 0
Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville Melbourne VIC 3052
Country 10260 0
Australia
Phone 10260 0
+61 3 93456910
Fax 10260 0
+61 3 93455900
Email 10260 0
[email protected]
Contact person for scientific queries
Name 1188 0
Dr Jordana Bayer
Address 1188 0
Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville Melbourne VIC 3052
Country 1188 0
Australia
Phone 1188 0
+61 3 93457952
Fax 1188 0
+61 3 93455900
Email 1188 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23121Study protocol  [email protected]
23122Informed consent form  [email protected]
23123Ethical approval  [email protected]

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4210Study results articleYes Hiscock H, Bayer JK, Price A, Ukoumunne OC, Rogers... [More Details] 1316-(Uploaded-06-11-2019-09-31-06)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.