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Trial registered on ANZCTR


Registration number
ACTRN12619000009112p
Ethics application status
Not yet submitted
Date submitted
19/12/2018
Date registered
8/01/2019
Date last updated
8/01/2019
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 Workshop
The Fear-Less Triple P workshop intervention is a one-day (6 hour) parent group workshop with a follow-up implementation phone call one week later. The workshop 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.
Each of these topics will be covered verbally by the presenter, participants will have opportunities to role-play new skills, and accompanying written materials and a workbook will reinforce the information presented.
In the follow-up implementation phone call, parents have time to discuss how the implementation of the program has gone at home and the provisional psychologist will trouble shoot any issues with them.
The Fear-Less workshop is a manualised workshop, and will be delivered by two provisional clinical psychologists from The University of Queensland. The one-day workshop will be conducted face-to-face with a group of parents, the implementation phone call (typically one hour long) will be conducted via telephone one week later. This is a one-off workshop that will be held at the Cystic Fibrosis Service at the Queensland Children's Hospital. The workshop has been adapted/specialized for parents of anxious children, and while the provisional psychologists running the workshop will be aware of the unique challenges faces by the Cystic Fibrosis (CF) population, the workshop itself will not be adapted for the 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
Half of the participants will be randomly assigned to a waitlist control group, who will go about their CF treatment as usual. The waitlist control group will be offered the workshop free of cost three months after the treatment group.
Control group
Active

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] 354659 0
Children's average procedural anxiety as measured by the Adapted Perception of Procedures Questionnaire (PPQ) - Parent Report
Timepoint [5] 354659 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [6] 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 [6] 354660 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [7] 354661 0
Average ratings on child behavioural problems as scored on the Child Adjustment and Parent Efficacy Scale (CAPES)
Timepoint [7] 354661 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [8] 354662 0
Average ratings of Cystic Fibrosis specific child behavioural problems as scored on the Cystic Fibrosis Problems Checklist (CFPC)
Timepoint [8] 354662 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [9] 354663 0
Average parental fear of their children's disease progression as scored on the Fear of Disease Progression Questionnaire (FoP)
Timepoint [9] 354663 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [10] 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 [10] 354664 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [11] 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 [11] 354665 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [12] 354666 0
Children's physical health as indicated by Forced Expiratory Volume in One Second (FEV1) measured using a spirometer during a pulmonary function test (data linkage to hospital records).
Timepoint [12] 354666 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [13] 354667 0
Children's physical health as indicated by Body Mass Index (BMI) (data linkage to hospital records).
Timepoint [13] 354667 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [14] 354668 0
Children's physical health as indicated by Number of Hospitalisations in the past six months (data linkage to hospital records).
Timepoint [14] 354668 0
3 months post-intervention
6 months post-intervention
12 months post-intervention
Secondary outcome [15] 355168 0
Workshop acceptability, as measured using the Triple-P parent satisfaction survey
Timepoint [15] 355168 0
1 week post intervention

Eligibility
Key inclusion criteria
Inclusion criteria include: Children with Cystic Fibrosis attending the Queensland Children's Hospital Cystic Fibrosis Service and their parents/caregivers. Children must be aged between 6 years and 12 year 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
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: Children who do not have Cystic Fibrosis and who are not attending the Queensland Children's Hospital Cystic Fibrosis Service. Patients aged <6 years or >12 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation into treatment groups will take place after screening for eligibility takes place, therefore the person conducting eligibility assessment will not be aware of participant allocation. Allocation concealment will take place via central randomisation by phone/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) - Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
This is a time-lag design, whereby all participants are given the same intervention, but the waitlist control group receives the intervention three months later than the active intervention group.
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 capped by the number of children attending the Queensland Children's Hospital CF Service (estimated maximum number is 100), 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 and clinical interviews (which produce a diagnosis and ratings of severity) in this project will be quantitative in nature. The following analysis plan will be applied to that quantitative data:
1. Data gathered from the screening surveys will be used to assess prevalence within the clinic, so will be primarily analysed as percentage rates. Associations between the factors, primarily the relationship between anxiety/depression and medical record data (Lung volume, BMI, and hospitalisations) will be explored through regression analyses.
2. Data gathered from the pre-, post-, and 3 month follow-up measures for the Fear-Less trial will be assessed using one-way ANOVAs, to compare the active treatment control to the waitlist control. The 6- and 12-month follow-up measures will not be compared between groups, as the waitlist group will have received the intervention at three months, so both groups’ data from these measures will be combined and used to show longitudinal trends of the intervention outcomes.
3. Data from the pre-trial procedural anxiety and fear of disease progression measures will be analysed independently, investigating the associations between these measures and the health outcomes and quality of life outcomes using regression analyses.

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
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)
QLD
Recruitment hospital [1] 12655 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 25077 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 301371 0
University
Name [1] 301371 0
The University of Queensland
Address [1] 301371 0
School of Psychology
McElwain Building,
The University of Queensland
Sir Fred Schonell Dr, St Lucia QLD 4072
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
Not yet submitted
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
Ethics approval number [1] 302109 0

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 Workshop is a viable and effective treatment option for anxiety in the child CF population. The project will be conducted at the Cystic Fibrosis Service at Queensland Children’s Hospital, and all children aged 6-12 and their parents will be invited to participate. The project will involve 1. A short screening survey to establish incidence of anxiety, procedural anxiety and depression among the children with CF and their parents; 2. A longer survey investigating health-related quality of life, fear of disease progression, and pre-measures for the Fear-Less program; 3. A one-day parenting workshop on Fear-Less Triple-P; and 4. Follow-up surveys and measures at 3, 6 and 12 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 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
vanessa.cobham@mater.uq.edu.au
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
h.kimball@uq.edu.au
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
h.kimball@uq.edu.au

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?
Clinical study report
Ethical approval
Summary results
No Results