Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000606088
Ethics application status
Approved
Date submitted
16/07/2010
Date registered
27/07/2010
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A cognitive behavioural intervention program for behaviourally inhibited children and their parents.
Scientific title
Cognitive Behavioural Treatment versus Waitlist
for behaviourally inhibited preschool children and their parents: Changes in temperament, anxiety symptoms and diagnosis.
Secondary ID [1] 252230 0
NIL
Universal Trial Number (UTN)
U1111-1116-0283
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behavioural Inhibition and anxiety 257754 0
Condition category
Condition code
Mental Health 257930 257930 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapy will be based on the COOL KIDS treatment program (Rapee, Wignall, Hudson and Schniering, 2000)] 5 x 1 hour sessions delivered in individual format over 8 weeks (fortnight between sessions 3,4 and 5) . Treatment includes parents and child.
The cognitive behavioural intervention includes the following components:
Parent training (training parents to encourage brave behaviour, reduce parent overprotection and parental anxiety)
Exposure (gradually step-by-step facing the child's feared situations)
Cognitive restructuring (providing skills for parents and children to reduce threat based thoughts).
Each participant in the intervention group will receive all three components.
Intervention code [1] 256819 0
Prevention
Intervention code [2] 256868 0
Treatment: Other
Intervention code [3] 256869 0
Behaviour
Comparator / control treatment
Waitlist. The waitlist group will be offered the intervention at the end of the waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 258794 0
Anxiety symptoms (Preschool Anxiety Scale- Parent report) and the Anxiety Disorder Interview Schedule for Children (Diagnostic interview with parent)
Timepoint [1] 258794 0
Pre treatment, post treatment and 3 month follow-up
Primary outcome [2] 258795 0
Anxiety Disorder: Anxiety Disorder Interview Schedule for Children (Diagnostic interview with parent) based on the Diagnostic Statistical Manual of Mental Disorders (DSM-IV).
Timepoint [2] 258795 0
Pre treatment, post treatment and 3 month follow-up
Primary outcome [3] 258796 0
Temperament (inhibition)
Laboratory observation (based on procedures developed by Jerome Kagan)
Children's Temperament Questionnaire (parent report).
Timepoint [3] 258796 0
Pre treatment, post treatment and 3 month follow-up
Secondary outcome [1] 264858 0
Parental anxiety
Depression Anxiety and Stress Scale
Anxiety Disorders Interview Schedule (based on the Diagnostic Statistical Manual of Mental Disorders; DSM-IV).
Timepoint [1] 264858 0
Pre treatment, post treatment and 3 month follow-up
Secondary outcome [2] 264859 0
Parent behaviour (Observed and Questionnaires)
Five Minute Speech Sample (Parent describes child and relationship for 5 uninterrupted minutes).
Five minute parent-child interaction task (while child prepares a presentation)
Parent self-report questionnaires (Overprotection Scale; Parent Protection Scale)
Timepoint [2] 264859 0
Pre treatment, post treatment and 3 month follow-up

Eligibility
Key inclusion criteria
Inhibited temperament: Children scoring one standard deviation above the mean on the Approach scale of the Children's Temperament Questionnaire
Minimum age
42 Months
Maximum age
54 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to speak and comprehend English. Participants receiving ongoing treatment for mental health related concerns.

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)
Children will be assessed based on parent report and observation. Children who are 1 standard deviation above the mean on parent reported inhibition will be invited to participate in the randomisation to either waitlist or active treatment.
Allocation will be concealed: allocation involves contacting the holder of the allocation schedule who is located at a central administration site (different floor, different office).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator
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
1/09/2010
Actual
6/09/2010
Date of last participant enrolment
Anticipated
Actual
4/10/2011
Date of last data collection
Anticipated
Actual
25/05/2012
Sample size
Target
100
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 257293 0
Government body
Name [1] 257293 0
Australian Research Council
Country [1] 257293 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, NSW 2109
Country
Australia
Secondary sponsor category [1] 256538 0
None
Name [1] 256538 0
Address [1] 256538 0
Country [1] 256538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259320 0
Macquarie University
Ethics committee address [1] 259320 0
Macquarie University, NSW 2109
Ethics committee country [1] 259320 0
Australia
Date submitted for ethics approval [1] 259320 0
16/07/2010
Approval date [1] 259320 0
11/08/2010
Ethics approval number [1] 259320 0
5201000902

Summary
Brief summary
Anxiety disorders in children are prevalent, understudied, and underreported phenomena. Despite well-documented efficacy of treatments for child anxiety, research into the prevention of these disorders remains comparatively limited. An inhibited temperament style has been identified as an early life predictor of the anxiety disorders. Behavioural Inhibition (BI) is defined in terms of reactions of withdrawal, wariness, avoidance and shyness in novel, unfamiliar situations. The findings from our research suggests that inhibited children are significantly more likely than uninhibited children to have an anxiety disorder at baseline and also more likely to develop an anxiety disorder over time. Other factors, such as parenting style, maternal anxiety and interpretation bias also increase the risk for anxiety in this population. In this study we will examine the efficacy of an intervention program aimed at reducing anxiety and risk for future anxiety in BI preschool children by focusing on BI and family environment risk factors.
Trial website
www.ceh.mq.edu.au
Trial related presentations / publications
Currently in preparation
Public notes

Contacts
Principal investigator
Name 31402 0
Prof Jennifer L Hudson
Address 31402 0
Department of Psychology
Macquarie University
NSW 2109
Country 31402 0
Australia
Phone 31402 0
+612 98508668
Fax 31402 0
Email 31402 0
[email protected]
Contact person for public queries
Name 14649 0
A/Prof Dr Helen Dodd
Address 14649 0
Department of Psychology
Macquarie University
NSW 2109
Country 14649 0
Australia
Phone 14649 0
+61 2 98508055
Fax 14649 0
+61 2 98508062
Email 14649 0
[email protected]
Contact person for scientific queries
Name 5577 0
Prof Jennifer L Hudson
Address 5577 0
Department of Psychology
Macquarie University
NSW 2109
Country 5577 0
Australia
Phone 5577 0
+61 2 9850 8668
Fax 5577 0
02 98508062
Email 5577 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.