Internet-Based Mental Health Program for Cystic Fibrosis

(iCF-PWR Trial)

Recruiting at 1 trial location

Overseen By Dainelle M Caissie, M.Sc.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Severe cognitive impairment, major comorbid illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

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 children and adolescents with cystic fibrosis (CF) and their healthy siblings. The main questions it aims to answer are: * Does the program improve the mental health such as depression and anxiety symptoms? * Does the program improve overall quality of life? * Does the program improve self-efficacy - an individual's belief in their ability to complete tasks to achieve their goals? Participants will: * Fill out an online survey asking questions about their personal and health information, as well as their mental health before the program * Complete the online mental health program * Fill out an online survey asking questions about their mental health after completing the program, and 1-month and 3-months following completing the program Participants be compared against another group of children with CF and their healthy siblings who are on a waitlist and receiving usual CF treatment. Researchers will compare participants scores before starting the program with their scores immediately following completing the program, 1-month, and 3-month after completing the program. Researchers hope to develop a program that improves mental health, quality of life, self-efficacy, and knowledge about CF.

Who Is on the Research Team?

Kristi D Wright, Ph.D.

Principal Investigator

University of Regina

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 8-12 who either have cystic fibrosis (CF) or are siblings of someone with CF. They must be able to speak and read English. It's not suitable for those with severe cognitive impairments or major medical/psychiatric conditions that could limit participation.

Inclusion Criteria

I can speak and read English.

I am between 8 and 12 years old.

I have cystic fibrosis or my sibling does.

Exclusion Criteria

I do not have severe cognitive issues or major illnesses that would prevent me from participating fully.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Program Completion

Participants complete the online mental health program, which includes reviewing modules and additional mental health resources

3-6 weeks

Online access

Follow-up

Participants are monitored for changes in mental health, quality of life, and self-efficacy at 1-month and 3-months post-program

3 months

Online surveys at 1-month and 3-months

What Are the Treatments Tested in This Trial?

Interventions

• Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program

Trial Overview The trial tests an Internet-delivered mental health program designed for kids with CF and their healthy siblings. It evaluates the program's impact on depression, anxiety, quality of life, self-efficacy, and knowledge about CF compared to usual treatment over several months.

How Is the Trial Designed?

Group I: iCF-PWR Program Experimental Treatment 1 Intervention

Parents are encouraged to review the program along with their child and then children are encouraged to complete the program 1-2 additional times (or as many times as they like). It is suggested that modules be completed at a rate of 1-2 per week, with program completion ranging from 3-6 weeks. Additional mental health resources are provided at the end of the program.

Group II: Standard Care Active Control 1 Intervention

Participants will continue to receive their usual standard care related to CF (i.e., accessing services through their local health authority and CF clinic). Following the proposed maximum program completion time-frame (i.e., 6 weeks) and follow-up time period (i.e., 3 months), those in the standard care groups will be provided access to iCF-PWR.

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Saskatchewan Health Authority - Regina Area

Collaborator

Trials

29

Recruited

5,400+

Provincial Health Services Authority

Collaborator

Trials

40

Recruited

31,900+