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Anxiety disorders in children with cystic fibrosis and their families: Trialing the Fear-Less Triple P Workshop

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000009112
Enrollment
20
Registered
2019-01-08
Start date
2022-05-02
Completion date
2022-07-01
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 on

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.

Sponsors

Hayley Kimball
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026