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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
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early Intervention for Shy Preschool Children
Scientific title
Parent education for Preschool-Aged Children at Risk for Anxiety Disorders aimed at reducing high levels of inhibition
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 3202 0
Condition category
Condition code
Mental Health 3365 3365 0 0

Study type
Description of intervention(s) / exposure
Education for parents about coping and management strategies. involves 8 group sessions for both parents - one session per week for 8 weeks. Topics covered include parenting strategies, contingency management, exposure hierarchies for children, and anxiety management for parents. Topics are delivered by a clinical psychologist in a standard behavioural treatment format. Intervention is assisted by handouts for parents.
Intervention code [1] 2939 0
Intervention code [2] 2940 0
Comparator / control treatment
No intervention. In the control condition, no intervention is offered and all assessments are simply repeated at 6 months. Ie the control condition involves children and parents who do not receive any intervention.
Control group

Primary outcome [1] 4253 0
Change in inhibition. Assessed by observational assessment and Behavioural Inhibition Questionnaire.
Timepoint [1] 4253 0
All measures are given at baseline and again at 6 months.
Primary outcome [2] 4254 0
Change in Anxiety diagnoses. Assessed by Anxiety Disorders Interview Schedule.
Timepoint [2] 4254 0
All measures are given at baseline and again at 6 months.
Secondary outcome [1] 7184 0
Parent anxiety. Assessed by Depression Anxiety Stress Scales.
Timepoint [1] 7184 0
All measures are given at baseline and again at 6 months.

Key inclusion criteria
Participants are included if the child scores 2 standard deviations above the norm on the measure of inhibited behaviour and also demonstrates high behavioural inhibition in a laboratory observation and also has one parent with an anxiety disorder.
Minimum age
3 Years
Maximum age
5 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Developmental disability
Lack of English in parent

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants screened by questionnaire and then invited to observational (laboratory) assessment. Eligible participants were not allocated to conditions until after inclusion in the trial - ie once criteria for inhibition of child and anxiety disorder in parent had been met. Hence initial inclusion in trial was independent of treatment allocation. Allocation to intervention was conducted by the study co-ordinator after assessment of participant eligibility by toss of a coin. Hence the person assessing participant eligibility did not know which treatment condition the participant would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After inclusion of eligible participants in trial, allocation to condition was done by the investigator by coin toss.
Masking / blinding
Open (masking not 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] 3435 0
Self funded/Unfunded
Name [1] 3435 0
Address [1] 3435 0
Country [1] 3435 0
Primary sponsor type
Macquarie University
Sydney 2109
Secondary sponsor category [1] 3077 0
Name [1] 3077 0
Address [1] 3077 0
Country [1] 3077 0

Ethics approval
Ethics application status
Ethics committee name [1] 5459 0
Macquarie University
Ethics committee address [1] 5459 0
Macquarie University
Sydney 2109
Ethics committee country [1] 5459 0
Date submitted for ethics approval [1] 5459 0
Approval date [1] 5459 0
Ethics approval number [1] 5459 0

Brief summary
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 28626 0
Address 28626 0
Country 28626 0
Phone 28626 0
Fax 28626 0
Email 28626 0
Contact person for public queries
Name 11783 0
Prof Ron Rapee
Address 11783 0
Dept of Psychology
Macquarie University
Sydney NSW 2109
Country 11783 0
Phone 11783 0
612 98508032
Fax 11783 0
Email 11783 0
Contact person for scientific queries
Name 2711 0
Prof Ron Rapee
Address 2711 0
Dept of Psychology
Macquarie University
Sydney NSW 2109
Country 2711 0
Phone 2711 0
612 98508032
Fax 2711 0
Email 2711 0

No information has been provided regarding IPD availability
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