CompletedNot Applicable

The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis

Canada9 participantsStarted 2023-09-06

Plain-language summary

The goal of the clinical trial is to test whether a mental health program that is delivered through the Internet works well for healthy children and adolescents with siblings with cystic fibrosis (CF). The main questions it aims to answer are: * Does the program improve the mental health and quality of life of healthy siblings? * Does the program improve the relationship between healthy children and adolescents and their sibling with CF? * Does the program help healthy siblings learn about CF? Participants will: * Fill out an online survey asking questions about their family and mental health before the program * Complete the online mental health program over five weeks * Fill out a weekly question asking about their mood for 10 weeks * Fill out an online survey asking questions about their family and mental health after the program Healthy children and adolescents with siblings with CF will be compared against themselves. Researchers will compare participants scores before starting the program with their scores during and after completing the program. Researchers hope to develop a program that improves mental health, quality of life, sibling relationships, and knowledge about CF.

Who can participate

Age range8 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * between the ages of 8 and 12 * have a child or adolescent sibling with cystic fibrosis * able to speak and read English Exclusion Criteria: * have a severe cognitive impairment or a major comorbid medical or psychiatric illness, as this may have interfered with their ability to participate in the program and evaluation process required for the study.

What they're measuring

Change in Mood and Anxiety Rating

Timeframe: 10 Weeks

Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C)

Timeframe: Baseline and Week 10 (post-intervention)

Change from Baseline in the Children's Depression Inventory-2 (CDI-2)

Timeframe: Baseline and Week 10 (post-intervention)

Change from Baseline in the Childhood Illness Attitudes Scale (CIAS)

Timeframe: Baseline and Week 10 (post-intervention)

Change from Baseline in the Childhood Anxiety Sensitivity Index (CASI)

Timeframe: Baseline and Week 10 (post-intervention)

Change from Baseline in the Intolerance of Uncertainty Scale-Revised (IUS-R)

Timeframe: Baseline and Week 10 (post-intervention)

Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0)

Timeframe: Baseline and Week 10 (post-intervention)

Trial details

NCT IDNCT06012084

SponsorUniversity of Regina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Cystic Fibrosis trials

Plain-language summary

Who can participate

Age range8 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Mood and Anxiety Rating

Timeframe: 10 Weeks

Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C)

Timeframe: Baseline and Week 10 (post-intervention)

Change from Baseline in the Children's Depression Inventory-2 (CDI-2)

Timeframe: Baseline and Week 10 (post-intervention)

Change from Baseline in the Childhood Illness Attitudes Scale (CIAS)

Timeframe: Baseline and Week 10 (post-intervention)

Change from Baseline in the Childhood Anxiety Sensitivity Index (CASI)

Timeframe: Baseline and Week 10 (post-intervention)

Change from Baseline in the Intolerance of Uncertainty Scale-Revised (IUS-R)

Timeframe: Baseline and Week 10 (post-intervention)

Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0)

Timeframe: Baseline and Week 10 (post-intervention)