← Back to Search

Internet-Based Mental Health Program for Cystic Fibrosis (iCF-PWR Trial)

N/A

Waitlist Available

Led By Kristi D Wright, Ph.D.

Research Sponsored by University of Regina

Eligibility Criteria Checklist

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

Must have

Can speak and read English. The research team does not have competence in other languages, further our program is delivered in English

Between the ages of 8 and 12

Must not have

Have a severe cognitive impairment or a major comorbid medical or psychiatric illness, as this may impede their ability to fully participate in the program and evaluation process

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3-months follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online program to improve mental health, quality of life, and self-efficacy in children/teens with CF and their siblings. Participants fill out surveys before/after completing the program.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a mental health intervention delivered via the Internet, there may not be direct physical side effects like in drug trials. However, participants might experience emotional discomfort when discussing personal issues during the program.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can speak and read English.

Select...

I am between 8 and 12 years old.

Select...

I have cystic fibrosis or my sibling does.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3-months follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3-months follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3-months follow up 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 Illness Attitudes Scale (CIAS) at 1 month

Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at 3 months

Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at Week 3-6

+16 more

Secondary study objectives

Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 1 Month

Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 3 Months

Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at Week 3-6

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: iCF-PWR ProgramExperimental Treatment1 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 CareActive Control1 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.

0 / 4Eligibility criteria met