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

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Regina

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kristi D Wright, Ph.D

Principal Investigator

University of Regina

Eligibility Criteria

This trial is for healthy children and adolescents aged 8 to 12 who have a sibling with cystic fibrosis. Participants must be able to speak and read English.

Inclusion Criteria

I am between 8 and 12 years old.

You have a brother or sister with cystic fibrosis who is between infancy and 18 years old.

You possess the ability to both read and converse in English.

Treatment Details

Interventions

iCF-PWR (Behavioral Intervention)

Trial OverviewThe trial tests an online mental health program (iCF-PWR) designed for siblings of individuals with CF, aiming to improve their mental health, quality of life, sibling relationships, and knowledge about CF.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: iCF-PWR InterventionExperimental Treatment1 Intervention

Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program is comprised of five text/voice-delivered, animated, interactive modules. The pathways are comprised of the same modules that take approximately 15 to 20 minutes to complete. Modules are comprised of web pages and/or screens with numerous illustrations and interactive components. Written module content will be presented verbally as well as in text format. The program modules include: (1) What is CF? (i.e., physiological explanation of CF, prevalence rate); (2) How does my sibling with CF stay healthy? (i.e., review of medication, nutrition, physiotherapy treatment, and why treatment is important); (3) How does CF affect me?; (4) Mental health awareness (i.e., introduction to cognitive behaviour model of emotions-thoughts, feelings, bodily sensations, and behaviours); and (5) Strategies (i.e., ways to challenge unhelpful thoughts, talking about emotions, relaxation).