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

N/A

Recruiting

Research Sponsored by University of Regina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

between the ages of 8 and 12

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if an online mental health program can help improve the mental health and quality of life for healthy children and adolescents who have siblings with cystic fibrosis (CF). The trial also

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since this is a non-medical intervention focusing on mental health through an internet-based program, there are no direct physical side effects expected from participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 8 and 12 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+6 more

Secondary study objectives

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

Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

0 / 1Eligibility criteria met