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iCF-PWR Intervention for Mental Health

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

Study 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.Check my eligibility

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.See study design

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

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

Primary outcome measures

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 outcome measures

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)

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

Find a Location

Who is running the clinical trial?

Saskatchewan Health Authority - Regina AreaOTHER

27 Previous Clinical Trials

5,508 Total Patients Enrolled

1 Trials studying Mental Health

120 Patients Enrolled for Mental Health

University of ReginaLead Sponsor

48 Previous Clinical Trials

8,506 Total Patients Enrolled

1 Trials studying Mental Health

120 Patients Enrolled for Mental Health

Provincial Health Services AuthorityOTHER

39 Previous Clinical Trials

31,585 Total Patients Enrolled

1 Trials studying Mental Health

120 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 the clinical trial open to individuals below the age of 50?

"To be eligible for participation in this study, applicants must fall within the age range of 8 to 12 years old. It is worth noting that there are a total of 98 trials available for individuals under the age of 18 and 389 trials targeting subjects over the age of 65."

Answered by AI

Are participants currently being recruited for this ongoing clinical trial?

"Indeed, as indicated on clinicaltrials.gov, this ongoing clinical trial is currently seeking eligible patients. The trial was initially posted on September 6th, 2023 and most recently updated on January 2nd, 2024."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, the information provided on clinicaltrials.gov indicates that this particular clinical trial is actively enrolling participants. The trial was initially posted on September 6th, 2023 and recently updated on January 2nd, 2024. This study aims to recruit a total of 10 patients from one designated location."

Answered by AI

Which individuals meet the criteria for participation in this medical study?

"This study aims to enroll a cohort of 10 pediatric patients, aged between 8 and 12 years old, who are diagnosed with cystic fibrosis. In addition to the age requirement, participants must have a sibling in the same age range who also has cystic fibrosis. Proficiency in spoken and written English is another prerequisite for inclusion in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06012084.

All > Cystic Fibrosis