Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
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.
Query!
Scientific title
Reduction in risk for anxiety among inhibited preschool children following a brief parent education program compared with no intervention.
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders
3870
0
Query!
Internalising disorders
3871
0
Query!
Condition category
Condition code
Mental Health
4068
4068
0
0
Query!
Anxiety
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
3598
0
Prevention
Query!
Comparator / control treatment
No intervention - repeated assessment only.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
4967
0
Number of anxiety disorders, assessed via structureed clinical diagnostic interview conducted by clinical psychologist.
Query!
Assessment method [1]
4967
0
Query!
Timepoint [1]
4967
0
1-3 weeks before start of intervention, then 12 months, 24 months, and 36 months following intervention.
Query!
Primary outcome [2]
4968
0
Extent of behavioural inhibition assessed in two ways: 1) parent reported questionnaires; 2) direct laboratory observation.
Query!
Assessment method [2]
4968
0
Query!
Timepoint [2]
4968
0
1-3 weeks before start of intervention, then 12 months, 24 months, and 36 months following intervention.
Query!
Secondary outcome [1]
8382
0
Maternal report of anxiety symptoms assessed via questionnaire.
Query!
Assessment method [1]
8382
0
Query!
Timepoint [1]
8382
0
1-3 weeks before start of intervention, then 12 months, 24 months, and 36 months following intervention.
Query!
Secondary outcome [2]
8383
0
Child self report of anxiety symptoms
Query!
Assessment method [2]
8383
0
Query!
Timepoint [2]
8383
0
36 mth only
Query!
Eligibility
Key inclusion criteria
Score on measure of inhibited behaviour at 1 standard deviation above norm. Demonstration of behavioural inhibition on laboratory observation.
Query!
Minimum age
3
Years
Query!
Query!
Maximum age
5
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Formal diagnosis of developmental disorder assessed during structured clinical diagnostic interview.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Selection of condition from a sealed container.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/06/2000
Query!
Actual
1/06/2000
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
1/12/2002
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2012
Query!
Sample size
Target
146
Query!
Accrual to date
Query!
Final
146
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Funding & Sponsors
Funding source category [1]
4053
0
Government body
Query!
Name [1]
4053
0
National Health and Medical Research Council (NHMRC)
Query!
Address [1]
4053
0
Level 5, 20 Allara Street,
Canberra, ACT. 2601.
Query!
Country [1]
4053
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Macquarie University
Query!
Address
Balaclava Road, North Ryde. Sydney NSW. 2109
Query!
Country
Australia
Query!
Secondary sponsor category [1]
3648
0
None
Query!
Name [1]
3648
0
Query!
Address [1]
3648
0
Query!
Country [1]
3648
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
6131
0
Macquarie University Human Research Ethics Committee
Query!
Ethics committee address [1]
6131
0
Macquarie University,
Balaclava Road, North Ryde.
Sydney. NSW. 2109
Query!
Ethics committee country [1]
6131
0
Australia
Query!
Date submitted for ethics approval [1]
6131
0
Query!
Approval date [1]
6131
0
28/04/2000
Query!
Ethics approval number [1]
6131
0
Query!
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.
Query!
Trial website
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
29069
0
Query!
Address
29069
0
Query!
Country
29069
0
Query!
Phone
29069
0
Query!
Fax
29069
0
Query!
Email
29069
0
Query!
Contact person for public queries
Name
12226
0
Prof Ronald Rapee
Query!
Address
12226
0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde,
Sydney. NSW. 2109
Query!
Country
12226
0
Australia
Query!
Phone
12226
0
+61 2 98508032
Query!
Fax
12226
0
+61 2 98508062
Query!
Email
12226
0
[email protected]
Query!
Contact person for scientific queries
Name
3154
0
Prof Ronald Rapee
Query!
Address
3154
0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde,
Sydney. NSW. 2109
Query!
Country
3154
0
Australia
Query!
Phone
3154
0
+61 2 98508032
Query!
Fax
3154
0
+61 2 98508062
Query!
Email
3154
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF