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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Cool Little Kids Online: A parenting program to increase young children’s confidence and prevent anxiety problems
Scientific title
Is the Cool Little Kids Online parenting program effective in reducing anxiety in young children who are highly inhibited?
Secondary ID [1] 284816 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety in young children 292198 0
Condition category
Condition code
Mental Health 292536 292536 0 0

Study type
Description of intervention(s) / exposure
Participants receive 10 weeks access to the Cool Little Kids Online website program. The 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 and colleagues. Modules take about 30 to 60 minutes to complete. Parents are advised to work at an ideal pace of one module per week, although they can choose to work at whichever pace suits them best. 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 emails upon completion of each module, half-way through the program, and after 2 weeks of not logging in to the program.

Two versions of the program are being evaluated: one is self-guided, and the other is guided by a clinician. Participants allocated to the clinician arm will receive up to 2 support phone calls during the study, one after module 2 (or week 3) and one after module 5 (or week 6).
Intervention code [1] 289608 0
Intervention code [2] 289609 0
Comparator / control treatment
We are comparing two versions of the same intervention: one self-guided and one guided by support phone calls from a psychology clinician.
Control group

Primary outcome [1] 292398 0
Child anxiety symptoms as assessed with the Revised Preschool Anxiety Scale
Timepoint [1] 292398 0
10 weeks
Primary outcome [2] 292399 0
Child anxiety diagnoses as assessed with the Online Assessment of Preschool Anxiety
Timepoint [2] 292399 0
10 weeks
Secondary outcome [1] 308866 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 [1] 308866 0
10 weeks
Secondary outcome [2] 308867 0
Program use/adherence as assessed by computer logs (modules accessed, number of logins)
Timepoint [2] 308867 0
10 weeks
Secondary outcome [3] 308868 0
Child internalising symptoms as assessed with the Strengths and Difficulties Questionnaire – Emotional Symptoms Subscale
Timepoint [3] 308868 0
10 weeks
Secondary outcome [4] 308869 0
Over-protective parenting practices, as assessed with the Over-involved/protective parenting scale
Timepoint [4] 308869 0
10 weeks
Secondary outcome [5] 308870 0
Life interference from child anxiety, assessed with the Children's Anxiety Life Interference Scale (CALIS) adapted for preschool children
Timepoint [5] 308870 0
10 weeks

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 and a printer
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
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
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. Once they have completed the questionnaire they will be automatically redirected to the registration page of the Cool Little Kids Online website, where they can register for the program and immediately gain access to it.

Randomisation to group occurs at the end of the baseline questionnaire, and is calculated automatically using a computer script.
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 289429 0
Government body
Name [1] 289429 0
National Health and Medical Research Council
Address [1] 289429 0
GPO Box 1421 Canberra ACT 2601
Country [1] 289429 0
Funding source category [2] 289430 0
Name [2] 289430 0
auDA Foundation
Address [2] 289430 0
114 Cardigan Street, Carlton VIC 3053
Country [2] 289430 0
Primary sponsor type
La Trobe University
Bundoora, Victoria, 3086
Secondary sponsor category [1] 288116 0
Name [1] 288116 0
Address [1] 288116 0
Country [1] 288116 0
Other collaborator category [1] 278005 0
Name [1] 278005 0
Professor Ron Rapee
Address [1] 278005 0
Department of Psychology, Macquarie University, NSW 2109
Country [1] 278005 0

Ethics approval
Ethics application status
Ethics committee name [1] 291186 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 291186 0
La Trobe University Bundoora, Victoria 3086
Ethics committee country [1] 291186 0
Date submitted for ethics approval [1] 291186 0
Approval date [1] 291186 0
Ethics approval number [1] 291186 0

Brief summary
The study is an initial evaluation of Cool Little Kids Online, an online parenting program that aims to help inhibited (shy) young children be more confident and prevent them developing anxiety problems.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 49266 0
Dr Amy Morgan
Address 49266 0
School of Psychological Science
La Trobe University
Bundoora, Victoria, 3086
Country 49266 0
Phone 49266 0
+61 3 9479 5193
Fax 49266 0
Email 49266 0
Contact person for public queries
Name 49267 0
Dr Amy Morgan
Address 49267 0
School of Psychological Science
La Trobe University
Bundoora, Victoria, 3086
Country 49267 0
Phone 49267 0
+61 3 9479 5193
Fax 49267 0
Email 49267 0
Contact person for scientific queries
Name 49268 0
Dr Amy Morgan
Address 49268 0
School of Psychological Science
La Trobe University
Bundoora, Victoria, 3086
Country 49268 0
Phone 49268 0
+61 3 9479 5193
Fax 49268 0
Email 49268 0

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