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Trial registered on ANZCTR


Registration number
ACTRN12615000217505
Ethics application status
Approved
Date submitted
23/02/2015
Date registered
5/03/2015
Date last updated
22/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of Cool Little Kids Online: A parenting program to increase young children’s confidence and prevent anxiety problems
Scientific title
Randomised controlled trial of Cool Little Kids Online: A parenting program to prevent anxiety problems in young children
Secondary ID [1] 286194 0
Nil
Universal Trial Number (UTN)
U1111-1167-3162
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety in young children 294225 0
Condition category
Condition code
Mental Health 294545 294545 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to one of two conditions: immediate access to Cool Little Kids Online (intervention group), or delayed access after a 24-week period (control group). The Cool Little Kids Online program aims to help parents of shy young children who at risk of developing anxiety problems. The program has 8 interactive online modules containing a mix of written information, videos, audio narration, activities and parent experiential stories. The modules contain the same content as in the Cool Little Kids parenting group program developed by Rapee et al (2005). Modules take about 30 to 60 minutes to complete. The modules are designed to be completed sequentially at weekly intervals, with a new module becoming available each week. This means the program can be completed in 8 weeks, or participants can use the program at their own pace, as they will have access for 24 weeks. Just like the group parenting program, Cool Little Kids Online sets parents home practice tasks to work on with their child between modules. To encourage program adherence, participants receive automated emails when they complete a module and when each new module becomes available. Parents in the intervention group will be offered telephone support from a psychology clinician upon request only.
Intervention code [1] 291208 0
Prevention
Intervention code [2] 291209 0
Behaviour
Comparator / control treatment
Delayed access control group. The control group will receive access to the Cool Little Kids Online program after a delay of 24 weeks, once they have completed the 24-week questionnaire. The program will be provided 'as-is' with no support offered from a psychology clinician.
Control group
Active

Outcomes
Primary outcome [1] 294324 0
Child anxiety symptoms as assessed with the Revised Preschool Anxiety Scale (mean scores and proportion of reliably improved)
Timepoint [1] 294324 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [1] 313042 0
Child internalising symptoms as assessed with the Strengths and Difficulties Questionnaire – Emotional Symptoms Subscale
Timepoint [1] 313042 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [2] 313043 0
Life interference from child anxiety, assessed with the Children's Anxiety Life Interference Scale (CALIS) adapted for preschool children
Timepoint [2] 313043 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [3] 313044 0
Over-protective parenting practices, as assessed with the Over-involved/protective parenting scale
Timepoint [3] 313044 0
Baseline, 24 weeks
Secondary outcome [4] 313045 0
Program satisfaction/acceptability, as assessed by a feedback questionnaire adapted from Bayer et al (2011), with additional questions designed specifically for this study, e.g. using Likert scales.
Bayer, J. K., et al. (2011). The Cool Little Kids randomised controlled trial: Population-level early prevention for anxiety disorders. BMC Public Health 11: 11.
Timepoint [4] 313045 0
12 weeks
Secondary outcome [5] 313046 0
Child anxiety diagnoses as assessed with the Online Assessment of Preschool Anxiety (diagnostic status and number of diagnoses)
Timepoint [5] 313046 0
24-weeks

Eligibility
Key inclusion criteria
1. Parent of child aged between 3 and 6 years of age
2. Child is highly inhibited, as indicated by a score of 31 or more on the Short Temperament Scale for Children (STSC) – Approach subscale (Pedlow, Sanson, Prior, & Oberklaid, 1993; Prior, Sanson, & Oberklaid, 1989).
3. Access to the internet
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Parent reports that child has cerebral palsy, an intellectual disability, or severe autism
2. Parent is not a resident of Australia

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)
Participants will complete an online screening questionnaire to see if they are eligible to participate. This online screening questionnaire is automatically scored, and those who are ineligible will be automatically informed and will exit the survey. Those who are eligible will be invited to participate after reading more about the study, and will give their informed consent online. They will then be asked to complete the rest of the baseline questionnaire online. Randomisation to group occurs at the end of the baseline questionnaire, and is calculated automatically using a computer script. Parents in the immediate-access condition will be emailed instructions on how to log-in to the program once they have completed the baseline questionnaire. Parents in the delayed-access condition will be emailed these instructions once they have completed the third questionnaire after a waiting period of 24-weeks.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by a computer script that generates a random number between 0 and 1.
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290766 0
Government body
Name [1] 290766 0
National Health and Medical Research Council
Address [1] 290766 0
GPO Box 1421 Canberra ACT 2601
Country [1] 290766 0
Australia
Funding source category [2] 290767 0
Charities/Societies/Foundations
Name [2] 290767 0
auDA Foundation
Address [2] 290767 0
114 Cardigan Street, Carlton VIC 3053
Country [2] 290767 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 289451 0
None
Name [1] 289451 0
Address [1] 289451 0
Country [1] 289451 0
Other collaborator category [1] 278353 0
Individual
Name [1] 278353 0
Professor Ron Rapee
Address [1] 278353 0
Department of Psychology, Macquarie University, NSW 2109
Country [1] 278353 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292396 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 292396 0
La Trobe University Bundoora, Victoria 3086
Ethics committee country [1] 292396 0
Australia
Date submitted for ethics approval [1] 292396 0
27/02/2015
Approval date [1] 292396 0
01/04/2015
Ethics approval number [1] 292396 0

Summary
Brief summary
This study evaluates an online parenting program that aims to help shy/sensitive young children become more confident and prevent them developing anxiety problems. Parents will receive access to the website program immediately or after a 24-week delay, and will complete questionnaires at baseline, 12 weeks, and 24 weeks later.
Trial website
www.coollittlekids.org.au
Trial related presentations / publications
Morgan, A. J., Rapee, R. M., Salim, A., Goharpey, N., Tamir, E., McLellan, L. F., & Bayer, J. K. (2017). Internet-delivered parenting program for prevention and early intervention of anxiety problems in young children: Randomized controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry, 56(5), 417–425. doi:10.1016/j.jaac.2017.02.010

Morgan, A. J., Rapee, R. M., & Bayer, J. K. (2017). Increasing response rates to follow-up questionnaires in health intervention research: Randomized controlled trial of a gift card prize incentive. Clinical Trials, 14(4), 381-386. doi:10.1177/1740774517703320

Morgan, A. J., Rapee, R. M., Salim, A., & Bayer, J. K. (In press). Predicting response to an internet-delivered parenting program for anxiety in early childhood. Behavior Therapy, doi:10.1016/j.beth.2017.07.009
Public notes

Contacts
Principal investigator
Name 54962 0
Dr Amy Morgan
Address 54962 0
School of Psychology and Public Health, La Trobe University Bundoora, Victoria, 3086
Country 54962 0
Australia
Phone 54962 0
+61 3 9479 5193
Fax 54962 0
Email 54962 0
amy.morgan@latrobe.edu.au
Contact person for public queries
Name 54963 0
Dr Amy Morgan
Address 54963 0
School of Psychology and Public Health, La Trobe University Bundoora, Victoria, 3086
Country 54963 0
Australia
Phone 54963 0
+61 3 9479 5193
Fax 54963 0
Email 54963 0
amy.morgan@latrobe.edu.au
Contact person for scientific queries
Name 54964 0
Dr Amy Morgan
Address 54964 0
School of Psychology and Public Health, La Trobe University Bundoora, Victoria, 3086
Country 54964 0
Australia
Phone 54964 0
+61 3 9479 5193
Fax 54964 0
Email 54964 0
amy.morgan@latrobe.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