Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000009112
Ethics application status
Approved
Date submitted
19/12/2018
Date registered
8/01/2019
Date last updated
2/05/2022
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Anxiety disorders in children with cystic fibrosis and their families: Trialing the Fear-Less Triple P Workshop
Scientific title
Anxiety disorders in children with cystic fibrosis and their families: An exploration of the problem and proof-of-concept trial of the Fear-less Triple P intervention
Secondary ID [1] 296793 0
Nil
Universal Trial Number (UTN)
U1111-1225-0386
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 310688 0
Cystic Fibrosis 310689 0
Condition category
Condition code
Mental Health 309388 309388 0 0
Anxiety
Human Genetics and Inherited Disorders 309547 309547 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Fear-Less Triple P Online Workshop
The Fear-Less Triple P online workshop intervention is a 6-module self-directed online parent program. Each module typically takes 30-60 minutes to complete. The program covers the following content:
• Education about anxiety and its development;
• Strategies for promoting emotional resilience in children (‘emotion coaching’);
• Cognitive behavioural strategies for managing anxiety;
• Strategies for managing children’s anxiety.

The Fear-Less online program is based on the manualised Fear-Less group workshop, and is delivered by Professor Vanessa Cobham. Parents are able to login and complete the modules in their own time and at their own pace, but are required to complete the content within six weeks in the current study. Parents will be able to access the course content after the completion of the project. The program has been adapted/specialized for parents of anxious children, the workshop itself is not adapted for the cystic fibrosis (CF) population.
At the completion of the program participants will respond to feasibility and acceptability questions to assess the fidelity of the program for this population.
Intervention code [1] 313090 0
Behaviour
Intervention code [2] 313091 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308343 0
Mean child anxiety as measured on the Spence Children's Anxiety Scale (SCAS): Child Version
Timepoint [1] 308343 0
3 months post-intervention (primary time point)
6 months post-intervention
12 months post-intervention
Primary outcome [2] 308344 0
Mean child anxiety as measured on the Spence Children's Anxiety Scale (SCAS): Parent Report Version
Timepoint [2] 308344 0
3 months post-intervention (primary time point)
6 months post-intervention
12 months post-intervention
Primary outcome [3] 308345 0
Percentage of children meeting cut-off for clinical diagnosis of anxiety, as measured by the Anxiety Disorders Interview Schedule (ADIS-IV): Child Interview Schedule and Parent Interview Schedule
Timepoint [3] 308345 0
3 months post-intervention (primary time point)
6 months post-intervention
12 months post-intervention
Secondary outcome [1] 354655 0
Children's average mood rating as measured by the Mood and Feelings Questionnaire (MFQ) – Short Version – Child Self-Report
Timepoint [1] 354655 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [2] 354656 0
Children's average mood rating as measured by the Mood and Feelings Questionnaire (MFQ) – Short Version – Parent Report
Timepoint [2] 354656 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [3] 354657 0
Children's average procedural anxiety as measured by two subscales of the Pediatric Quality of Life Inventory (PEDS-QL); the Procedural Anxiety Module and the Treatment Anxiety Module
Timepoint [3] 354657 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [4] 354658 0
Children's average procedural anxiety as measured by two subscales of the Pediatric Quality of Life Inventory (PEDS-QL); the Procedural Anxiety Module and the Treatment Anxiety Module – Parent Version
Timepoint [4] 354658 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [5] 354660 0
Parents mental health functioning in three primary areas - depressed mood, anxiety, and stress, measured as average scores on the Depression, Anxiety and Stress Scale (DASS)
Timepoint [5] 354660 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [6] 354661 0
Average ratings on child behavioural problems as scored on the Child Adjustment and Parent Efficacy Scale (CAPES)
Timepoint [6] 354661 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [7] 354662 0
Average ratings of Cystic Fibrosis specific child behavioural problems as scored on the Cystic Fibrosis Problems Checklist (CFPC)
Timepoint [7] 354662 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [8] 354663 0
Average parental fear of their children's disease progression as scored on the Fear of Disease Progression Questionnaire (FoP)
Timepoint [8] 354663 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [9] 354664 0
Average children's health related quality of life as measured on the Cystic Fibrosis Questionnaire Child (CFQ Child) and the Cystic Fibrosis Questionnaire Child – Parent Version (CFQ-Parent)
Timepoint [9] 354664 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [10] 354665 0
Average children's health related quality of life as measured on the EQ-5D-Y (Youth) and the EQ-5D-Y (Youth – Parent Proxy Measure)
Timepoint [10] 354665 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [11] 355168 0
Workshop acceptability, as measured using the Triple-P parent satisfaction survey
Timepoint [11] 355168 0
1 week post intervention

Eligibility
Key inclusion criteria
Inclusion criteria include: Children with Cystic Fibrosis and their parents/caregivers. Children must be aged between 6 years and 14 years inclusive. Children and their parents/caregivers must not be severely intellectually impaired and therefore unable to complete the measures; and must be able to read and write English fluently to complete the measures. Finally, parents/caregivers must be of the belief that their child would benefit from learning how to manage anxiety more effectively to participate. Families will not be excluded if their child does not meet criteria for an anxiety diagnosis as we wish to be as inclusive as possible in the piloting stage.
Minimum age
6 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: Children who do not have Cystic Fibrosis. Patients aged <6 years or >14 years; those who are severely intellectually impaired and therefore unable to complete the measures; and those who cannot read or write English fluently and therefore are unable to complete the measures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As there is only one group, no allocation will take place.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As there is only one group, no allocation will take place.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
This is a single group pre- post- design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a proof-of-concept/acceptability trial, and our number of potential participants is quite low given prevalence rates of CF, we are not aiming to meet power requirements for this study. Any limitations to power will be discussed in future publications.

The majority of data taken from the survey measures in this project will be quantitative in nature. The following analysis plan will be applied to that quantitative data:
1. Associations between the factors will be explored through regression analyses.
2. Data gathered from the pre-, post-, 3-, 6- and 9-month follow-up measures for the Fear-Less trial will be assessed using repeated measures ANOVAs, to compare the scores at different time points.

Some of the evaluative measures of the acceptability and feasibility of the Fear-Less Trial will be in the form of qualitative data. In this case, survey responses will be coded for themes using the thematic analysis model developed by Braun and Clarke (2006; 2012). These themes will be analysed and interpreted, and will inform the ongoing development of the Fear-Less trial in the chronic health condition population.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
Date of last participant enrolment
Anticipated
1/07/2022
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22296 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 25077 0
4101 - South Brisbane
Recruitment postcode(s) [2] 37458 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 301371 0
University
Name [1] 301371 0
The University of Queensland
Country [1] 301371 0
Australia
Primary sponsor type
Individual
Name
Hayley Kimball
Address
School of Psychology
McElwain Building,
The University of Queensland
Sir Fred Schonell Dr, St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 301042 0
Individual
Name [1] 301042 0
Vanessa Cobham
Address [1] 301042 0
School of Psychology
McElwain Building,
The University of Queensland
Sir Fred Schonell Dr, St Lucia QLD 4072
Country [1] 301042 0
Australia
Other collaborator category [1] 280461 0
Individual
Name [1] 280461 0
Dr Tonia Douglas
Address [1] 280461 0
Respiratory and Sleep Medicine (5a)
Lady Cilento Children’s Hospital
501 Stanley Street
South Brisbane
QLD 4101
Country [1] 280461 0
Australia
Other collaborator category [2] 280462 0
Individual
Name [2] 280462 0
Matthew Sanders
Address [2] 280462 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
Brisbane QLD 4072
Country [2] 280462 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302109 0
Children’ s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 302109 0
Lady Cilento Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 302109 0
Australia
Date submitted for ethics approval [1] 302109 0
18/01/2019
Approval date [1] 302109 0
14/03/2022
Ethics approval number [1] 302109 0
HREC/19/QCHQ/47309
Ethics committee name [2] 310846 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 310846 0
The University of Queensland
Brisbane
QLD 4072
Ethics committee country [2] 310846 0
Australia
Date submitted for ethics approval [2] 310846 0
06/04/2022
Approval date [2] 310846 0
07/04/2022
Ethics approval number [2] 310846 0
2019/HE000887

Summary
Brief summary
The two primary aims of this project are to 1. Understand the anxiety experiences of children with cystic fibrosis (CF) and their parents, and 2. Determine whether the Fear-Less Triple-P Online Workshop is a viable and effective treatment option for anxiety in the child CF population. All children aged 6-14 with CF and their parents will be invited to participate. The project will involve 1. Pre- and post-intervention survey measures investigating anxiety, depression, procedural anxiety, health-related quality of life, fear of disease progression, and pre-measures for the Fear-Less program; 2. A six-module online parenting workshop on Fear-Less Triple-P; and 3. Follow-up surveys and measures at 3, 6 and 9 months. It is anticipated that the surveys and pre-measures will reveal significant challenges for both the children with CF and their parents, potentially affecting their treatment adherence and quality of life. It is also anticipated that the online Fear-Less Triple-P workshop will provide a viable, sustainable, and effective intervention option for anxiety among children with CF.
Trial website
Trial related presentations / publications
Public notes
We are studying anxiety and mental health within the cystic fibrosis population, but we are not studying cystic fibrosis itself.

Contacts
Principal investigator
Name 89138 0
A/Prof Vanessa Cobham
Address 89138 0
McElwain Building (24A)
Level 4, Room 411
The University of Queensland
Sir Fred Schonell Dr, St Lucia QLD 4072
Country 89138 0
Australia
Phone 89138 0
+61 -7-33469911
Fax 89138 0
Email 89138 0
[email protected]
Contact person for public queries
Name 89139 0
Ms Hayley Kimball
Address 89139 0
School of Psychology
McElwain Building (24A)
The University of Queensland
Sir Fred Schonell Dr, St Lucia QLD 4072
Country 89139 0
Australia
Phone 89139 0
+61 3365 6230
Fax 89139 0
Email 89139 0
[email protected]
Contact person for scientific queries
Name 89140 0
Ms Hayley Kimball
Address 89140 0
School of Psychology
McElwain Building (24A)
The University of Queensland
Sir Fred Schonell Dr, St Lucia QLD 4072
Country 89140 0
Australia
Phone 89140 0
+61 3365 6230
Fax 89140 0
Email 89140 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
Data collected consists of sensitive personal and health information, primarily belonging to children under the age of 12 years old. Confidentiality of data has therefore been prioritized.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5177Ethical approval  [email protected] 376520-(Uploaded-12-09-2019-10-12-38)-Study-related document.pdf
5178Clinical study report  [email protected]



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.