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Trial registered on ANZCTR


Registration number
ACTRN12608000351314
Ethics application status
Approved
Date submitted
28/05/2008
Date registered
24/07/2008
Date last updated
24/07/2008
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
Anxiety

Intervention/exposure
Study type
Interventional
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
Prevention
Intervention code [2] 2940 0
Behaviour
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
Active

Outcomes
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.

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Developmental disability
Lack of English in parent

Study design
Purpose of the study
Prevention
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
University
Name
Macquarie University
Address
Sydney 2109
Country
Australia
Secondary sponsor category [1] 3077 0
None
Name [1] 3077 0
Address [1] 3077 0
Country [1] 3077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5459 0
Macquarie University
Ethics committee address [1] 5459 0
Macquarie University
Sydney 2109
Ethics committee country [1] 5459 0
Australia
Date submitted for ethics approval [1] 5459 0
Approval date [1] 5459 0
05/11/2004
Ethics approval number [1] 5459 0
D01934

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 11783 0
612 98508032
Fax 11783 0
Email 11783 0
Ron.Rapee@mq.edu.au
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
Australia
Phone 2711 0
612 98508032
Fax 2711 0
Email 2711 0
Ron.Rapee@mq.edu.au

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