Please note that the ANZCTR website will be unavailable from 12am until 6am (AEST) on Sunday 22nd September 2019. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
A brief education program for parents of preschool children at risk for internalising disorders.
Scientific title
Reduction in risk for anxiety among inhibited preschool children following a brief parent education program compared with no intervention.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 3870 0
Internalising disorders 3871 0
Condition category
Condition code
Mental Health 4068 4068 0 0

Study type
Description of intervention(s) / exposure
Brief parent education - 6, 90-minute group sessions in total - 5 sessions weekly, then a final one after 1 month break. Total intervention - 9 weeks. Parents learn: In vivo exposure for their child; improved parenting strategies; psychoeducation; cognitive restructuring.
Intervention code [1] 3598 0
Comparator / control treatment
No intervention - repeated assessment only.
Control group

Primary outcome [1] 4967 0
Number of anxiety disorders, assessed via structureed clinical diagnostic interview conducted by clinical psychologist.
Timepoint [1] 4967 0
1-3 weeks before start of intervention, then 12 months, 24 months, and 36 months following intervention.
Primary outcome [2] 4968 0
Extent of behavioural inhibition assessed in two ways: 1) parent reported questionnaires; 2) direct laboratory observation.
Timepoint [2] 4968 0
1-3 weeks before start of intervention, then 12 months, 24 months, and 36 months following intervention.
Secondary outcome [1] 8382 0
Maternal report of anxiety symptoms assessed via questionnaire.
Timepoint [1] 8382 0
1-3 weeks before start of intervention, then 12 months, 24 months, and 36 months following intervention.
Secondary outcome [2] 8383 0
Child self report of anxiety symptoms
Timepoint [2] 8383 0
36 mth only

Key inclusion criteria
Score on measure of inhibited behaviour at 1 standard deviation above norm. Demonstration of behavioural inhibition on laboratory observation.
Minimum age
3 Years
Maximum age
5 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Formal diagnosis of developmental disorder assessed during structured clinical diagnostic interview.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was made after participant eligibility had been determined. Allocation was made by blindly selecting participant condition from a container.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Selection of condition from a sealed container.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4053 0
Government body
Name [1] 4053 0
National Health and Medical Research Council (NHMRC)
Address [1] 4053 0
Level 5, 20 Allara Street,
Canberra, ACT. 2601.
Country [1] 4053 0
Primary sponsor type
Macquarie University
Balaclava Road, North Ryde. Sydney NSW. 2109
Secondary sponsor category [1] 3648 0
Name [1] 3648 0
Address [1] 3648 0
Country [1] 3648 0

Ethics approval
Ethics application status
Ethics committee name [1] 6131 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 6131 0
Macquarie University,
Balaclava Road, North Ryde.
Sydney. NSW. 2109
Ethics committee country [1] 6131 0
Date submitted for ethics approval [1] 6131 0
Approval date [1] 6131 0
Ethics approval number [1] 6131 0

Brief summary
The study aimed to reduce the development of internalising disorders such as anxiety and depression by providing a brief education program for parents of preschool aged children who are at increased risk for these problems. Children were selected if they were highly shy and inhibited. Parents either received 6, 90 minute sessions providing information about how to reduce inhibition in their child, or received no intervention. It was expected that the brief intervention would result in reduced inhibition in the short term and hence reductions in anxiety and depression in the longer term.
Trial website
Trial related presentations / publications
Rapee, R.M., Kennedy, S., Ingram, M., Edwards, S., & Sweeney, L. (2005). Prevention and early intervention of anxiety disorders in inhibited preschool children. Journal of Consulting and Clinical Psychology, 73, 488-497.

Rapee, R.M., Kennedy, S., Ingram, M., Edwards, S., & Sweeney, L. (2010). Altering the trajectory of anxiety in at-risk young children. American Journal of Psychiatry, 167, 1518-1525.

Rapee, R.M. The preventative effects of a brief, early intervention for preschool-aged children at risk for internalising: Follow-up into middle adolescence. (2013). Journal of Child Psychology and Psychiatry, 54 (7), 780-788.
Public notes

Principal investigator
Name 29069 0
Address 29069 0
Country 29069 0
Phone 29069 0
Fax 29069 0
Email 29069 0
Contact person for public queries
Name 12226 0
Prof Ronald Rapee
Address 12226 0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde,
Sydney. NSW. 2109
Country 12226 0
Phone 12226 0
+61 2 98508032
Fax 12226 0
+61 2 98508062
Email 12226 0
Contact person for scientific queries
Name 3154 0
Prof Ronald Rapee
Address 3154 0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde,
Sydney. NSW. 2109
Country 3154 0
Phone 3154 0
+61 2 98508032
Fax 3154 0
+61 2 98508062
Email 3154 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary