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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3-months follow up

Awards & highlights

iCF-PWR Trial 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.Check my eligibility

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.See study design

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.

iCF-PWR Trial 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.

iCF-PWR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

iCF-PWR 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Saskatchewan Health Authority - Regina AreaOTHER

27 Previous Clinical Trials

5,398 Total Patients Enrolled

1 Trials studying Mental Health

10 Patients Enrolled for Mental Health

Provincial Health Services AuthorityOTHER

39 Previous Clinical Trials

31,475 Total Patients Enrolled

1 Trials studying Mental Health

10 Patients Enrolled for Mental Health

University of ReginaLead Sponsor

48 Previous Clinical Trials

8,396 Total Patients Enrolled

1 Trials studying Mental Health

10 Patients Enrolled for Mental Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial available for seniors over the age of sixty?

"In accordance with this study's inclusion criteria, the age range for participants must be between 8 and 12."

Answered by AI

Are there specific characteristics that make individuals more suitable for this research endeavor?

"Patients who have been diagnosed with cystic fibrosis and fall between the ages of 8-12 are eligible to be enrolled in this clinical trial that aims for a recruitment goal of 120 participants."

Answered by AI

Is this analysis currently in the process of enrolling participants?

"The information on clinicaltrials.gov shows that this study is not presently recruiting participants. Initially posted in October of 2023 and last updated the 25th of August, it appears there are currently 492 other trials enrolling patients instead."

Answered by AI

What results are researchers expecting to achieve from this experiment?

"The aim of this research, which will be evaluated at Baseline and Week 3-6 (post-intervention), is to measure the shift in State-Trait Anxiety Inventory for Children (STAI-C) scores over a one month period. Secondary outcomes include change from baseline on both parent versions of the CDI2 and STAI scales after three months and six weeks respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work?

2024. "Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06020274.

All > Cystic Fibrosis > Mental Health