Preventing early anxiety disorders

ISRCTN	ISRCTN30996662
DOI	https://doi.org/10.1186/ISRCTN30996662
Secondary identifying numbers	N/A

Submission date: 18/01/2010
Registration date: 18/03/2010
Last edited: 17/06/2021

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 Jordana Bayer
Scientific

Centre for Community Child Health
Royal Children's Hospital Melbourne
Flemington Rd
Parkville, Victoria
3052
Australia

Email	jordana.bayer@mcri.edu.au

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Preventing early internalising problems in the preschool setting: a randomised controlled trial
Study objectives	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(s)	Royal Childrens Hospital Melbourne Ethics and Research Committee pending approval as of 20/01/2010 (ref: EHRC 21942). Estimated approval date is September 2010.
Health condition(s) or problem(s) studied	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	Behavioural
Primary outcome measure	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 study start date	01/02/2010
Completion date	30/04/2014

Eligibility

Participant type(s)	Other
Age group	Child
Sex	All
Target number of participants	Target sample size is 525
Total final enrolment	545
Key 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
Key exclusion criteria	Parents with insufficient English to participate
Date of first enrolment	01/02/2010
Date of final enrolment	30/04/2014

Locations

Countries of recruitment

Australia

Study participating centre

Centre for Community Child Health

Parkville, Victoria
3052
Australia

Sponsor information

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

Level 1
16 Marcus Clarke St
Canberra, ACT
2601
Australia

Website	http://www.nhmrc.gov.au/
"ROR"	https://ror.org/011kf5r70

Funders

Funder type

Research council

National Health and Medical Research Council (NHMRC) (Australia) (ref: 607302)
Government organisation / National government

Alternative name(s): National Health and Medical Research Council, Australian Government, NHMRC National Health and Medical Research Council, NHMRC
Location: Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	05/01/2011		Yes	No
Results article	results	01/08/2018		Yes	No
Results article	2-year follow-up results	01/08/2020	30/11/2020	Yes	No
Results article	follow-up results	01/06/2021	17/06/2021	Yes	No

Editorial Notes

17/06/2021: Publication reference added.
30/11/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
16/05/2018: Publication reference added.