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

Cystic Fibrosis Clinical Trial

Official title: The Development and Evaluation of an Internet-delivered Mental Health Prevention Program for Healthy Child Siblings of Individuals With Cystic Fibrosis

Status Recruiting

Clinical Trial Summary

The goal of the clinical trial is to test whether a mental health program that is delivered through the Internet works well for healthy children and adolescents with siblings with cystic fibrosis (CF). The main questions it aims to answer are:

• Does the program improve the mental health and quality of life of healthy siblings?

• Does the program improve the relationship between healthy children and adolescents and their sibling with CF?

• Does the program help healthy siblings learn about CF?

Participants will:

• Fill out an online survey asking questions about their family and mental health before the program

• Complete the online mental health program over five weeks

• Fill out a weekly question asking about their mood for 10 weeks

• Fill out an online survey asking questions about their family and mental health after the program

Healthy children and adolescents with siblings with CF will be compared against themselves. Researchers will compare participants scores before starting the program with their scores during and after completing the program. Researchers hope to develop a program that improves mental health, quality of life, sibling relationships, and knowledge about CF.

Clinical Trial Description

BACKGROUND: Healthy siblings of individuals with chronic illnesses, such as with cystic fibrosis (CF), have been shown to experience elevated psychological symptoms (e.g., depression, anxiety), negative psychological adjustment, and internalizing behaviours. Psychoeducation, sibling-oriented care, and involvement in siblings' treatments have demonstrated positive outcomes for siblings in terms of psychological wellbeing, social support, and quality of life. At present, there are currently no tailored mental health programs for healthy siblings of individuals with CF. Despite these advances, there is currently no specific mental health program designed for healthy siblings of individuals with CF in Canada. One viable and appealing option for the delivery of mental health services that would eliminate several of the barriers encountered in face-to-face methods of service delivery (e.g., travel to access care, financial restrictions) is through the Internet. Support exists for the effectiveness and efficacy of Internet-delivered psychological treatments for healthy children and children with a range of acute and chronic health conditions. As such, an Internet-delivered method of mental health service delivery designed to target the specific needs of healthy siblings of individuals with CF may be beneficial. The overall goal of the project is to evaluate a recently developed evidence-based, Internet-delivered mental health prevention program for families with CF [called the Internet-Delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource program (iCF-PWR)] living in Saskatchewan, that may be helpful in improving mental health and quality of life.

PARTICIPANTS: Six children (aged 8 to 12 years) with CF will be recruited from CF clinics and CF chapters in Canada. Research ethics approval has been approved in those respective health care institutions.

METHODS/PROCEDURES: Preliminary parent consent will be obtained over the phone. A web link (using Qualtrics) to an informed consent/assent form, demographics form, and questionnaires (i.e., measures of CF health, anxiety, depression, health anxiety, anxiety sensitivity, intolerance of uncertainty, quality of life, disease knowledge, and perception of their sibling relationship) will be e-mailed to parent caregiver. The parent caregiver will help facilitate the child's completion of questionnaires online using Qualtrics, a web-based survey software that enables a user-friendly model of conducting surveys. Parents will also complete two questionnaires about the healthy sibling's anxiety, and depression symptoms. Completion of the questionnaires will take approximately one hour. These measures will be completed again upon completion of the program. A link to the post-program questionnaires will be provided via email to parent caregivers to be completed after the program has been completed by the child. Child participants will be also asked to complete a series of one-item ratings of mood and anxiety prior to beginning the program (i.e., phase A) and during completion of the program (i.e., phase B) using Qualtrics. Each phase of the study will be approximately five weeks in length.

Once enrolled, parent caregivers will be provided with a username/password. Participants will be instructed to keep their username/password private. A contact e-mail of the research coordinator will be provided for technical support and instructions on how to operate the site. All contact with participants will be via e-mail, although a telephone number for the research coordinator will also be provided. Supervision of contact with child participants and parent caregivers will be provided by the research supervisor (i.e., Dr. Kristi Wright). Informatics of participant use of the program will be collected (e.g., amount of time spent completing each module, program completion time). Participants will be encouraged to complete one module per week. A reminder e-mail will be sent to parents if their child has not logged onto the program at least once per week. Participants will also be sent email reminders on the days they have been scheduled to complete a rating of mood and anxiety.

ANALYSES: Statistical analyses will be performed using IBM SPSS Statistics-Version 25. Visual analyses are the primary analyses used to determine whether there may be a functional (i.e., three demonstrations of the effectiveness of the intervention effect) or causal relationship between the intervention and the outcome variables. Visual analysis refers to reaching a judgment about the reliability or consistency of an intervention's effects by visually examining the graphed data. The program's effectiveness will be evaluated primarily by examining the changes between baseline (phase A) and post-program (phase B) measures, in addition to changes across the repeated momentary mood and anxiety measure. Baseline and post-program measures and the mood and anxiety ratings will be presented graphically to enable visual inspection. The visual inspection of data will also include analyzing trends in change over time and changes in variability of outcome measures.

If the data suggests a functional or causal relationship may be present, the visual analyses will be supplement with a quantitative analysis method evaluating the magnitude of the intervention effect. Descriptive statistics will be computed for total scores from the outcome measures. Healthy siblings' baseline and post-program total scores from the measure of interest will also be compared to existing community and/or normative data. A series of independent sample t-tests will be computed to compare healthy siblings to similar aged children to assess for potential differences across samples. To evaluate the magnitude of change in outcomes measures from baseline and post-program, a Reliable Change Index (RCI) will be calculated as an indicator of clinically significant change. The RCI will be calculated for each participant by taking their pre-test and post-test total scores and dividing it by the standard error of the difference. ;

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Internet-based Intervention
• Mental Health

• NCT number: NCT06012084
• Study type: Interventional
• Source: University of Regina
• Contact: Shelby M Shivak, M.A.
• Phone: 3065506874
• Email: shivak3s@uregina.ca
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Completion date: April 2024