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.