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Trial registered on ANZCTR


Registration number
ACTRN12609000058279
Ethics application status
Approved
Date submitted
31/10/2008
Date registered
23/01/2009
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Date results information initially provided
13/11/2018
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
Anxiety

Intervention/exposure
Study type
Interventional
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
Prevention
Comparator / control treatment
No intervention - repeated assessment only.
Control group
Active

Outcomes
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

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Formal diagnosis of developmental disorder assessed during structured clinical diagnostic interview.

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)
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
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)
NSW

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
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road, North Ryde. Sydney NSW. 2109
Country
Australia
Secondary sponsor category [1] 3648 0
None
Name [1] 3648 0
Address [1] 3648 0
Country [1] 3648 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 6131 0
Approval date [1] 6131 0
28/04/2000
Ethics approval number [1] 6131 0

Summary
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

Contacts
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
Australia
Phone 12226 0
+61 2 98508032
Fax 12226 0
+61 2 98508062
Email 12226 0
Ron.Rapee@mq.edu.au
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
Australia
Phone 3154 0
+61 2 98508032
Fax 3154 0
+61 2 98508062
Email 3154 0
Ron.Rapee@mq.edu.au

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