Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001019099
Ethics application status
Approved
Date submitted
20/08/2009
Date registered
22/11/2010
Date last updated
23/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cool Little Kids
Scientific title
Early Intervention program for pre-schoolers at risk of anxiety
Secondary ID [1] 253125 0
none
Universal Trial Number (UTN)
Trial acronym
CLK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety in preschool children 243549 0
Condition category
Condition code
Mental Health 239853 239853 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the parents of the child with anxiety, they will go through group education sessions where they will learn skills like cognitive restructuring, exposure and reinforcements to help their child overcome their anxiety.

The children with anxiety will undergo 6 sessions of social skills training concurrently.

Parent education and child sessions are administered by a trained therapist and will be 1.5hrs per session for 6 sessions over 10 weeks.
Intervention code [1] 241155 0
Treatment: Other
Comparator / control treatment
Waitlist controls who will be offered the parent education sessions after the 6 months (as the parent education sessions have been shown in previous trials to be useful).
Control group
Active

Outcomes
Primary outcome [1] 240619 0
Reduction in anxiety in children as measured on Behavioural Inhibition Questionnaire
Timepoint [1] 240619 0
6 months after the pre-assessment
Primary outcome [2] 240620 0
Reduction in anxiety in children as measured on Preschool Anxiety Scale
Timepoint [2] 240620 0
6 months after the pre-assessment
Primary outcome [3] 240621 0
Reduction of anxiety in children as measured on Child Anxiety Life Interference Scale- Preschool Version
Timepoint [3] 240621 0
6 months after the pre-assessment
Primary outcome [4] 240622 0
Reduction of anxiety in children as measured on Child Behaviour Scale.
Timepoint [4] 240622 0
6 months after the pre-assessment
Primary outcome [5] 240623 0
Reduction of anxiety in children as measured on Anxiety Diagnositic Interview Schedule for Children- Parent Version (ADIS-C-Parent version)
Timepoint [5] 240623 0
6 months after the pre-assessment
Secondary outcome [1] 257260 0
Reduction in parent anxiety as measured on Depression Anxiety Stress Scale-21.
Timepoint [1] 257260 0
6 months after the pre-assessment

Eligibility
Key inclusion criteria
Child- High levels of shyness or anxiety as shown on parent report on Short Temperament Scale for Children.
Parent- Moderate levels of anxiety as shown on Depression Anxiety Stress Scale-21.
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If they do not meet both the inclusion criteria and if they have a severe developmental delay.

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)
Advertisements will be put up in preschools and interested parents will call. We will send out screening questionnaires to them to fill out. If they are eligible for the study, they will be randomly allocated to either treatment or waitlist control.

Allocation to groups is via cluster randomization by coin tossing prior to the clients being allocated to the group. The allocation was done by a research assistant while decisions of inclusion and exclusion were undertaken by the Primary investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be randomly allocated to treatment or waitlist group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
23/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237529 0
University
Name [1] 237529 0
Higher Degree Research Grant from Macquarie University
Country [1] 237529 0
Australia
Primary sponsor type
Individual
Name
Elizabeth Lau
Address
Department of Psychology
Macquarie University
NSW 2109

Australia
Country
Australia
Secondary sponsor category [1] 237003 0
None
Name [1] 237003 0
Address [1] 237003 0
Country [1] 237003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243660 0
MACQUARIE UNIVERSITY ETHICS REVIEW COMMITTEE (HUMAN RESEARCH)
Ethics committee address [1] 243660 0
Ethics committee country [1] 243660 0
Australia
Date submitted for ethics approval [1] 243660 0
24/08/2009
Approval date [1] 243660 0
10/09/2009
Ethics approval number [1] 243660 0
HE31JUL2009-D00062

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

Contacts
Principal investigator
Name 30072 0
Address 30072 0
Country 30072 0
Phone 30072 0
Fax 30072 0
Email 30072 0
Contact person for public queries
Name 13319 0
Elizabeth Lau
Address 13319 0
Dept. of Psychology
MACQUARIE UNIVERSITY NSW 2109
Country 13319 0
Australia
Phone 13319 0
+61 2 98508033
Fax 13319 0
+61 2 9850 8062
Email 13319 0
[email protected]
Contact person for scientific queries
Name 4247 0
Elizabeth Lau
Address 4247 0
Dept. of Psychology
MACQUARIE UNIVERSITY NSW 2109
Sydney
Country 4247 0
Australia
Phone 4247 0
+61 2 98508033
Fax 4247 0
+61 2 9850 8062
Email 4247 0
[email protected]

No information has been provided regarding IPD availability


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.