Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000659606
Ethics application status
Approved
Date submitted
17/06/2014
Date registered
24/06/2014
Date last updated
19/01/2016
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
Nil
Universal Trial Number (UTN)
U1111-1158-0991
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
Anxiety

Intervention/exposure
Study type
Interventional
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
Prevention
Intervention code [2] 289609 0
Behaviour
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
Active

Outcomes
Primary outcome [1] 292398 0
Child anxiety symptoms as assessed with the Revised Preschool Anxiety Scale
Timepoint [1] 292398 0
Baseline
10 weeks
Primary outcome [2] 292399 0
Child anxiety diagnoses as assessed with the Online Assessment of Preschool Anxiety
Timepoint [2] 292399 0
Baseline
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
Baseline
10 weeks
Secondary outcome [4] 308869 0
Over-protective parenting practices, as assessed with the Over-involved/protective parenting scale
Timepoint [4] 308869 0
Baseline
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
Baseline
10 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 and a printer
Minimum age
18 Years
Maximum age
No limit
Sex
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. 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
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
21/07/2014
Actual
3/08/2014
Date of last participant enrolment
Anticipated
Actual
21/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289429 0
Government body
Name [1] 289429 0
National Health and Medical Research Council
Country [1] 289429 0
Australia
Funding source category [2] 289430 0
Charities/Societies/Foundations
Name [2] 289430 0
auDA Foundation
Country [2] 289430 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 288116 0
None
Name [1] 288116 0
Address [1] 288116 0
Country [1] 288116 0
Other collaborator category [1] 278005 0
Individual
Name [1] 278005 0
Professor Ron Rapee
Address [1] 278005 0
Department of Psychology, Macquarie University, NSW 2109
Country [1] 278005 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291186 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 291186 0
Ethics committee country [1] 291186 0
Australia
Date submitted for ethics approval [1] 291186 0
Approval date [1] 291186 0
14/05/2014
Ethics approval number [1] 291186 0
14-021

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

Contacts
Principal investigator
Name 49266 0
Dr Amy Morgan
Address 49266 0
School of Psychological Science
La Trobe University
Bundoora, Victoria, 3086
Country 49266 0
Australia
Phone 49266 0
+61 3 9479 5193
Fax 49266 0
Email 49266 0
[email protected]
Contact person for public queries
Name 49267 0
Amy Morgan
Address 49267 0
School of Psychological Science
La Trobe University
Bundoora, Victoria, 3086
Country 49267 0
Australia
Phone 49267 0
+61 3 9479 5193
Fax 49267 0
Email 49267 0
[email protected]
Contact person for scientific queries
Name 49268 0
Amy Morgan
Address 49268 0
School of Psychological Science
La Trobe University
Bundoora, Victoria, 3086
Country 49268 0
Australia
Phone 49268 0
+61 3 9479 5193
Fax 49268 0
Email 49268 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
SourceTitleYear of PublicationDOI
EmbasePrevention and early intervention of anxiety problems in young children: A pilot evaluation of Cool Little Kids Online.2016https://dx.doi.org/10.1016/j.invent.2016.05.001
N.B. These documents automatically identified may not have been verified by the study sponsor.