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Preventing early anxiety disorders
ISRCTN ISRCTN30996662
DOI 10.1186/ISRCTN30996662
ClinicalTrials.gov identifier
EudraCT number
Public title Preventing early anxiety disorders
Scientific title Preventing early internalising problems in the preschool setting: a randomised controlled trial
Acronym N/A
Serial number at source N/A
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.
Lay summary
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
Countries of recruitment Australia
Disease/condition/study domain Child internalising (anxiety) problems
Participants - 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
Participants - exclusion criteria Parents with insufficient English to participate
Anticipated start date 01/02/2010
Anticipated end date 30/04/2014
Status of trial Completed
Patient information material
Target number of participants Target sample size is 525
Interventions 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
Primary outcome measure(s) Child internalising diagnoses and symptoms at 12 and 24 months post-baseline.
Secondary outcome measure(s) Evaluated at 12 and 24 months post-baseline:
1. Parenting practices
2. Parent mental health
3. Economic evaluation
Sources of funding National Health and Medical Research Council (NHMRC) (Australia) (ref: 607302)
Trial website
Publications 1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21208451
Contact name Dr  Jordana  Bayer
  Address Centre for Community Child Health
Royal Children's Hospital Melbourne
Flemington Rd
  City/town Parkville, Victoria
  Zip/Postcode 3052
  Country Australia
  Email jordana.bayer@mcri.edu.au
Sponsor National Health and Medical Research Council (NHMRC) (Australia)
  Address Level 1
16 Marcus Clarke St
  City/town Canberra, ACT
  Zip/Postcode 2601
  Country Australia
  Sponsor website: http://www.nhmrc.gov.au/
Date applied 18/01/2010
Last edited 09/03/2011
Date ISRCTN assigned 18/03/2010
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