Clinical trial NCT06020274: Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work?
Official title: Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource (iCF-PWR) Program: How Does it Work?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis in Children
Siblings
Mental Health
Internet-based Intervention
Keywords: cystic fibrosis
child
adolescent
siblings
mental health
Internet-based intervention
anxiety
depression
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Authority - Regina Area
name: Provincial Health Services Authority
First posted: 2023-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the iCF-PWR group or the standard care group. The investigators will follow CONSORT guidelines for non-pharmacological trials with 1:1 random assignment to iCF-PWR or standard care. As such, 30 children with CF/30 child siblings will be randomly assigned to the iCF-PWR group and 30 children with CF/30 child siblings will be randomly assigned to the standard care group.
Primary purpose: PREVENTION

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

* Does the program improve the mental health such as depression and anxiety symptoms?
* Does the program improve overall quality of life?
* Does the program improve self-efficacy - an individual's belief in their ability to complete tasks to achieve their goals?

Participants will:

* Fill out an online survey asking questions about their personal and health information, as well as their mental health before the program
* Complete the online mental health program
* Fill out an online survey asking questions about their mental health after completing the program, and 1-month and 3-months following completing the program

Participants be compared against another group of children with CF and their healthy siblings who are on a waitlist and receiving usual CF treatment. Researchers will compare participants scores before starting the program with their scores immediately following completing the program, 1-month, and 3-month after completing the program. Researchers hope to develop a program that improves mental health, quality of life, self-efficacy, and knowledge about CF.

Detailed description: BACKGROUND: Children with cystic fibrosis (CF) and family members have been shown to experience elevated psychological symptoms, such as depression and anxiety. Over the past decade, significant advances have been made in the care of people living with CF, including major steps toward assessing and promoting emotional wellness. Despite these advances, there has been no specific mental health program designed for families with CF in Canada until recently. To address the limitations of traditionally delivered mental health programs and lack of developed Internet-delivered mental health programs for children with CF and their siblings, the investigators created the self-guided Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program for children with CF and their child siblings. The program was designed with a stepped-care model in mind, whereby all children with CF and their child siblings could access and benefit from this preventative program (i.e., least resource intensive intervention). If a child was in need of more intensive services prior to or following iCF-PWR completion, then services could be accessed through regular avenues (i.e., CF team, local outpatient/inpatient public mental health services, or private practice). The self-guided iCF-PWR program was informed by those with lived experiences with CF, the empirical literature \[i.e., CF, mental health disorders in childhood and adolescence with chronic illnesses, universal mental health prevention in children and adolescence, stepped care, and team expertise. Individual contributions from specific children with CF and child siblings directed the development of individual program avatars and provided the personal stories and experiences embedded in the program modules. Preliminary evidence suggests that the program is deemed acceptable. However, to date the efficacy of the iCF-PWR is unknown.

PARTICIPANTS: G\*Power 3.1 was used to calculate the study sample size based upon on our primary analyses (i.e., mixed model analysis of variance ANOVA\]). Assuming 80% power, an alpha of 0.05, and effect size of 0.25 (small to medium effect), a sample size of at least 24 participants in each group would be needed. The investigators aim to recruit 30 participants per group to address attrition. 60 children (ages 8 to 12 years) with CF and 60 child siblings (ages 8 to 12 years) will be recruited from the CF clinics and CF Chapters, CF advocacy groups, advocacy groups for pediatric chronic illness across Canada in a 1-year prospective study. Participants will be randomly assigned to either the iCF-PWR group or the standard care group. The investigators will seek to have equal representation of gender across both groups. 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.

HYPOTHESES:

1. The iCF-PWR group will have significant reductions in self-reported anxiety symptoms from pre- to post-program and at follow-up time points compared to the standard care group.
2. The iCF-PWR group will have significant reductions in self-reported depressive symptoms from pre- to post-program and at follow-up time points compared to the standard care group.
3. The iCF-PWR group will have significant reductions in self-reported health anxiety from pre- to post-program and at follow-up time points compared to the standard care group.
4. The iCF-PWR group will have significant improvements in self-reported quality of life from pre- to post-program and at follow-up time points compared to the standard care group.
5. The iCF-PWR group will have significant improvements in self-reported self-efficacy from pre- to post-program and at follow-up time points compared to the standard care group.

METHODS/PROCEDURES: Parent/guardian will be provided an overview of procedure in initial email. Via Qualtrics (i.e., online survey platform) (1) parent/guardian will be asked to complete consent form/facilitate the endorsement of assent form with child and complete and complete a short personal/health demographics questionnaire about themselves and their child, and (2) their child will be asked to complete a series of self-report questionnaires assessing anxiety, depression, health anxiety, quality of life, self-efficacy, and disease knowledge (pre-program measurement). The parent caregiver will help facilitate the child's completion of questionnaires. Parent will be asked to complete measures of parent-rated child anxiety and depression. This will take 5 minutes. Via email, child and parent/guardian will be provided a link to complete these measures once the program is completed (post-program measurement) and at two follow-up time points (1 month and 3 months post-program). Measure of satisfaction will be completed by child at post-program as well. Measures will take approximately 30 to 40 minutes to complete at each time-point. Similar time-points for measure completion will be used for both study groups (i.e., iCF-PWR and standard care groups). However, the satisfaction questionnaire will not be completed by standard care group.

Parents are encouraged to review the program along with their child and then children are encouraged to complete the program at least 1 additional time, with an overall program completion ranging from 3 to 6 weeks. Children can review the program as many times as they would like. Once enrolled, parent caregiver will be provided with a username/password. Parents/participants will be instructed to keep their username/password private. They will also be encouraged to access the program in a private area, preferably in their own homes. A contact e-mail will be given for technical support and instructions on how to operate the site. All contact with the parents/participants will be via e-mail during program, although a phone number will also be provided. Inquiries via email and telephone will be fielded by study coordinator. A reminder e-mail will be sent to parents if child has not logged onto the program at least 1x/week.

ANALYSES: Statistical analyses will be performed using IBM SPSS Statistics-Version 26. Demographic data will be summarized as means and standard deviations for continuous data and frequencies for categorical data. Preliminary analyses will explore the potential impact of demographic variables (e.g., age, gender) on primary and secondary outcome variables. If demographic variables have a statistically significant impact on outcome measures, those variables will be included as covariate(s) in primary and secondary analyses. An intention-to-treat (ITT) design will be employed for all primary and secondary analyses. Primary analyses will be three 2 (group: iCF-PWR vs standard care) x 4 (time of assessment: pre-program vs. post-program vs. 1 month follow-up vs. 3 months follow-up) multi-level modeling (equivalent to mixed- model ANOVAs) to examine the effect of the intervention on the primary outcome measures (i.e., anxiety, depression, health anxiety). Secondary analyses will be two 2 (group: iCF-PWR vs standard care) x 4 (time of assessment: pre-program vs post-program vs 1 month follow-up vs 3 months follow-up) multilevel modeling to examine the effect of the intervention on the secondary outcome measures (i.e., quality of life, self-efficacy).

Eligibility criteria: Inclusion Criteria:

* between the ages of 8 and 12
* have a CF diagnosis or are a sibling of a child with CF
* can speak and read English. The research team does not have competence in other languages, further our program is delivered in English

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at Week 3-6
timeFrame: Baseline and Week 3-6 (post-intervention)
measure: Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at 1 Month
timeFrame: Baseline and 1-month follow up
measure: Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at 3 Months
timeFrame: Baseline and 3-months follow up
measure: Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at Week 3-6
timeFrame: Baseline and Week 3-6 (post-intervention)
measure: Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at 1 month
timeFrame: Baseline and 1-month follow up
measure: Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at 3 months
timeFrame: Baseline and 3-months follow up
measure: Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at Week 3-6
timeFrame: Baseline and Week 3-6 (post-intervention)
measure: Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at 1 month
timeFrame: Baseline and 1-month follow up
measure: Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at 3 months
timeFrame: Baseline and 3-months follow up
measure: Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at Week 3-6
timeFrame: Baseline and Week 3-6 (post-intervention)
measure: Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at 1 month
timeFrame: Baseline and 1-month follow up
measure: Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at 3 months
timeFrame: Baseline and 3-months follow up
measure: Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at Week 3-6
timeFrame: Baseline and Week 3-6 (post-intervention)
measure: Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 1 Month
timeFrame: Baseline and 1-month follow up
measure: Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 3 Months
timeFrame: Baseline and 3-months follow up
measure: Change from Baseline in the Disease Knowledge Questionnaire at Week 3-6
timeFrame: Baseline and Week 3-6 (post-intervention)
measure: Change from Baseline in the Disease Knowledge Questionnaire at 1 Month
timeFrame: Baseline and 1-month follow up
measure: Change from Baseline in the Disease Knowledge Questionnaire at 3 Months
timeFrame: Baseline and 3-months follow up
measure: Participants Qualitative Perception of Program Satisfaction at Week 3-6
timeFrame: Week 3-6 (post-intervention)
Secondary outcomes:
measure: Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at Week 3-6
timeFrame: Baseline and Week 3-6 (post-intervention)
measure: Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 1 Month
timeFrame: Baseline and 1-month follow up
measure: Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 3 Months
timeFrame: Baseline and 3-months follow up
measure: Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at Week 3-6
timeFrame: Baseline and Week 3-6 (post-intervention)
measure: Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 1 Month
timeFrame: Baseline and 1-month follow up
measure: Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 3 Months
timeFrame: Baseline and 3-months follow up
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Regina
country: Canada
facility: Saskatchewan Health Authority
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Kristi D Wright, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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