Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001793202
Ethics application status
Approved
Date submitted
24/10/2018
Date registered
2/11/2018
Date last updated
15/03/2019
Date data sharing statement initially provided
2/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cool Kids Taking Control Online Program for Children Experiencing Bullying and Anxiety.
Scientific title
Reducing the impact of bullying victimisation on children's mental health outcomes: A randomised controlled trial evaluating the efficacy of the Cool Kids - Taking Control online program.
Secondary ID [1] 296406 0
Nil known
Universal Trial Number (UTN)
U1111-1222-7465
Trial acronym
CKTC-O
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 310160 0
Bullying Victimisation 310161 0
Condition category
Condition code
Mental Health 308909 308909 0 0
Anxiety
Mental Health 308910 308910 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised clinical trial with two conditions: Cool Kids - Taking Control (Treatment) and Treatment-as-Usual (Control). Eligible participants aged 7-12 years in the treatment group will gain immediate access to a 10-week online intervention based on the evidence-based Cool Kids program. Children and their participating parent/s will receive instruction on how to use the online platform and will be informed that they can log in to the program as many times as they like during the week. They are encouraged to work through all of the weekly session content in the week that it is assigned so that they are then ready to move on to the next session. Program content will be released to families on a weekly, incremental basis and families will be informed that they can access current and previous weeks content for the entire intervention period. Both child and parent session content is provided through the online program. The online program is interactive and is in the form of short videos with characters, voice-overs, wording (similar to a PowerPoint with sound) and downloadable handouts that assist in explaining and practising the session material. Weekly therapist support will be provided to the participating parent/s via brief (20 minute) scheduled telephone calls. This support will assist families in understanding program content, problem-solving and address any questions related to program material.
Intervention code [1] 312742 0
Treatment: Other
Comparator / control treatment
Participants in the Treatment-as-usual group will be referred back to their school for ten weeks. They will complete the post-assessment (week 11) and follow-up assessment (6-months later) and will then be offered the opportunity to complete the Taking Control program with therapist support.
Control group
Active

Outcomes
Primary outcome [1] 307879 0
Primary Outcome 1: Clinical anxiety in participants completing the online Taking Control program will be assessed by The Anxiety Disorders Interview Schedule for Children - Parent Version (ADIS-IV-C/P: Silverman & Albano, 1996).
Timepoint [1] 307879 0
Timepoint: Baseline, 11 weeks (Primary Endpoint), and at 6-months follow-up.
Primary outcome [2] 307907 0
Bullying victimisation experienced by children participating in the Cool Kids - Taking Control study will be assessed using a child- and parent-report version of the Revised Olweus Bully/Victim Questionnaire (Olweus, 1996).
Timepoint [2] 307907 0
Timepoint: Baseline, 11 weeks (Primary Endpoint), and at 6-months follow-up.
Secondary outcome [1] 353205 0
Overall global functioning for children in the study will be assessed by The Children’s Global Assessment Scale (Schaffer, Gould, Brasic, Ambrosini, Fischer, Bird & Aluwahlia, 1983).
Timepoint [1] 353205 0
Post-intervention/ TAU (11 weeks) and at 6-month follow-up.
Secondary outcome [2] 353365 0
Anxiety symptoms will be measured using The Spence Children’s Anxiety Scale (SCAS: Spence, 1998).
Timepoint [2] 353365 0
Timepoint: Baseline, 11 weeks, and at 6-months follow-up.
Secondary outcome [3] 353367 0
Children's emotional symptoms will be measured by The Strengths and Difficulties Questionnaire (Goodman, 1997).
Timepoint [3] 353367 0
Baseline, 11 weeks, and at 6-months follow-up.
Secondary outcome [4] 353368 0
Depression symptoms will be assessed by the Short Mood and Feeling Questionnaire (Angold et al., 1995).
Timepoint [4] 353368 0
Baseline, 11 weeks, and at 6-months follow-up.
Secondary outcome [5] 353369 0
Self-efficacy for coping and peer aggression as measured by the Coping Self-Efficacy Scale (CSES; a shortened version of Singh and Bussey, 2011).
Timepoint [5] 353369 0
Baseline, 11 weeks, and at 6-months follow-up.

Eligibility
Key inclusion criteria
The sample will consist of children aged 7-12 years from across Australia, including from both regional and rural areas. Children will be included in the study if they report being bullied “three or more times” in the previous school term (10-weeks) and simultaneously meet the DSM-5 criteria for a diagnosis of an anxiety disorder as their primary, and therefore most interfering, disorder. Participants receiving pharmacological treatment will be included in the study if their medication has been stable for two months prior to the assessment and there are no foreseeable plans for a medication change before commencing treatment.

Participants must be willing to provide informed consent (parent consent and child assent) and comply with the requirements of the study will be included. Anxiety diagnosis will be assessed using the ADIS-IV-C/P child and parent versions. This amended form of the ADIS-IV has already been provided to the ethics committee (Ref #: 5201100542).

One primary caregiver will need to be involved in the study with their child. They will act in the role as 'coach' and will be responsible for completing measures pertaining to their child (as listed) and will participate in the weekly phone calls with the therapist. The measures are only related to the children in the study and therefore there are no inclusion criteria for parents, other than their willingness to be involved and to play the role as 'coach' over the course of the intervention. Families will be informed that they will need access to a computer or iPad/ tablet in order to access the program, and a telephone.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude children if they are exhibiting life threatening suicidal ideation; considered to be at risk of harm due to abuse; have a significant intellectual impairment; have a diagnosis of Autism Spectrum Disorder; have unmanaged psychotic symptoms; or are additionally receiving therapeutic treatment for victimisation and anxiety outside of school. Children excluded from the study will be referred to an appropriate health professional.

We will exclude families that do not have access to an electronic device suitable for engaging with the Cool Kids - Taking Control Online program. They will also be excluded if they do not have access to a telephone or cannot commit to weekly 20 minute phone calls over the course of the intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes will be used for group allocation and the holder of these will be 'off-site' or at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using a computer-based random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proportion of participants who no longer meet criteria for their principal anxiety diagnosis and any anxiety diagnosis will be examined using a chi-squared test. Mixed models containing random factors for subject and fixed effects for treatment group and time (including interactions) will be fitted to measures of child- and parent-reported symptoms, diagnostic severity, global functioning and quality of life. Both intent-to-treat and treatment-completer analyses will be conducted.
For the intent-to-treat analyses, assessment of 147 children will allow for an estimated 15% reduction to account for applicants who don’t meet the inclusion criteria. Eligible participants will then be randomised to treatment group. A sample size of 128 children will be sufficient to detect a medium effect size (d=.5) with adequate power (80%: 2-tailed). A medium effect is meaningful for a clinical population and is consistent with the mean effects across anxiety.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/11/2018
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
128
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301015 0
Charities/Societies/Foundations
Name [1] 301015 0
Australian Rotary Health
Country [1] 301015 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road, North Ryde
NSW, 2109, Australia
Country
Australia
Secondary sponsor category [1] 300602 0
None
Name [1] 300602 0
Address [1] 300602 0
Country [1] 300602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301770 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 301770 0
Ethics committee country [1] 301770 0
Australia
Date submitted for ethics approval [1] 301770 0
11/04/2018
Approval date [1] 301770 0
27/07/2018
Ethics approval number [1] 301770 0
5201829413314

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3192 3192 0 0
/AnzctrAttachments/376246-Ethics approval.pdf

Contacts
Principal investigator
Name 88042 0
Prof Jennie Hudson
Address 88042 0
Macquarie University
The Centre for Emotional Health
The Australian Hearing Hub
Level 1
16 University Ave
Macquarie University NSW 2109
Country 88042 0
Australia
Phone 88042 0
+61 2 9850 8711
Fax 88042 0
+61 (2) 9850 6578
Email 88042 0
[email protected]
Contact person for public queries
Name 88043 0
Theresa Kidd
Address 88043 0
Macquarie University
The Centre for Emotional Health
The Australian Hearing Hub
Level 1
16 University Ave
Macquarie University NSW 2109
Country 88043 0
Australia
Phone 88043 0
+61 (2) 9850 8711
Fax 88043 0
+61 (2) 9850 6578
Email 88043 0
[email protected]
Contact person for scientific queries
Name 88044 0
Jennie Hudson
Address 88044 0
Macquarie University
The Centre for Emotional Health
The Australian Hearing Hub
Level 1
16 University Ave
Macquarie University NSW 2109
Country 88044 0
Australia
Phone 88044 0
+61 (2) 9850 8711
Fax 88044 0
+61 (2) 9850 6578
Email 88044 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will need to discuss this with the Centre for Emotional Health staff.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
35Ethical approval    376246-(Uploaded-29-10-2018-12-34-06)-Study-related document.pdf



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.