Condition category
Mental and Behavioural Disorders
Date applied
18/01/2010
Date assigned
18/03/2010
Last edited
09/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jordana Bayer

ORCID ID

Contact details

Centre for Community Child Health
Royal Children's Hospital Melbourne
Flemington Rd
Parkville
Victoria
3052
Australia
jordana.bayer@mcri.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Preventing early internalising problems in the preschool setting: a randomised controlled trial

Acronym

Study hypothesis

This population-level randomised trial aims to test a preventive parenting program in the preschool setting for children systematically screened as at-risk of internalising problems due to temperamental inhibition. We hypothesise that:
1. Children whose parents enter the program will do better 12 and 24 months after baseline (the first two years of school for most) than control children on the study outcomes:
1.1. Fewer children with internalising disorders
1.2. Lower mean scores on early child internalising symptoms
1.3. Lower mean scores on harsh and overprotective parenting
1.4. Lower mean scores on parent internalising problems
2. The prevention program will be acceptable and cost-effective

We will also examine differential effectiveness according to parent mental health and family level of disadvantage.

Ethics approval

Royal Childrens Hospital Melbourne Ethics and Research Committee pending approval as of 20/01/2010 (ref: EHRC 21942). Estimated approval date is September 2010.

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

Child internalising (anxiety) problems

Intervention

Masking occurs at randomisation, with group allocation concealed from researchers and participants until allocation is complete.

Arm A:
Six-session group parenting program, delivered in the local community by an early childhood professional, focusing on ways to develop the child's bravery skills by reducing overprotective parenting interactions.

Arm B:
Usual care from the preschool, early childhood and health services in the community.

Total duration of treatment: 2 - 3 months (6 x 90-minute group parenting sessions)
Total duration of follow-up: 24 months post-baseline

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Child internalising diagnoses and symptoms at 12 and 24 months post-baseline.

Secondary outcome measures

Evaluated at 12 and 24 months post-baseline:
1. Parenting practices
2. Parent mental health
3. Economic evaluation

Overall trial start date

01/02/2010

Overall trial end date

30/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents of preschool children in their year before starting school in 2011
2. In four Melbourne local government areas
3. Children screened as temperamentally inhibited, either sex

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Target sample size is 525

Participant exclusion criteria

Parents with insufficient English to participate

Recruitment start date

01/02/2010

Recruitment end date

30/04/2014

Locations

Countries of recruitment

Australia

Trial participating centre

Centre for Community Child Health
Parkville, Victoria
3052
Australia

Sponsor information

Organisation

National Health and Medical Research Council (NHMRC) (Australia)

Sponsor details

Level 1
16 Marcus Clarke St
Canberra
ACT
2601
Australia

Sponsor type

Research council

Website

http://www.nhmrc.gov.au/

Funders

Funder type

Research council

Funder name

National Health and Medical Research Council (NHMRC) (Australia) (ref: 607302)

Alternative name(s)

NHMRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

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. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21208451

Publication citations

  1. Protocol

    Bayer JK, Rapee RM, Hiscock H, Ukoumunne OC, Mihalopoulos C, Clifford S, Wake M, The Cool Little Kids randomised controlled trial: population-level early prevention for anxiety disorders., BMC Public Health, 2011, 11, 11, doi: 10.1186/1471-2458-11-11.

Additional files

Editorial Notes