Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work?
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorUniversity of Regina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program
BehavioralThe iCF-PWR program is a self-guided mental health prevention program designed for families with CF. Upon logging on to the iCF-PWR, the viewer will see two paths (i.e., child with CF or sibling) and will be encouraged by program narrator to choose the appropriate path. Each pathway (i.e., child with CF or sibling) is comprised of five text/voice-delivered, animated, interactive modules: (1) CF education, (2) CF health, (3) emotions and CF, (4) cognitive behaviour model of emotions, and (5) coping strategies. Each module takes 15-20 minutes to complete.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: iCF-PWR ProgramExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at Week 3-6
The STAI-C measures general anxiety in children on a continuous scale with items being rated on a 3-point Likert scale reflecting the frequency of anxiety symptom. Total scores can range from a minimum score of 20 to a maximum score of 60.
Time frame
Baseline and Week 3-6 (post-intervention)2
Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at 1 Month
The STAI-C measures general anxiety in children on a continuous scale with items being rated on a 3-point Likert scale reflecting the frequency of anxiety symptom. Total scores can range from a minimum score of 20 to a maximum score of 60.
Time frame
Baseline and 1-month follow up3
Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at 3 Months
The STAI-C measures general anxiety in children on a continuous scale with items being rated on a 3-point Likert scale reflecting the frequency of anxiety symptom. Total scores can range from a minimum score of 20 to a maximum score of 60.
Time frame
Baseline and 3-months follow up4
Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at Week 3-6
The CDI-2 measures cognitive, affective, and behavioural symptoms of depression in children and adolescents on a continuous scale. Each item is rated on a 3-point Likert scale ranging from 0 (absence of symptom) to 2 (definite symptom). Total raw scores are converted into T-scores with a score of 65 being indicative clinically significant depressive symptoms.
Time frame
Baseline and Week 3-6 (post-intervention)Secondary outcomes
1
Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at Week 3-6
The CDI-2 P assesses a parent's observation of their child's or adolescent's cognitive, affective, and behavioural symptoms of depression. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 2 (much or most of the time). Total raw scores are converted into T-scores with a score of 65 being indicative clinically significant depressive symptoms.
Time frame
Baseline and Week 3-6 (post-intervention)2
Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 1 Month
The CDI-2 P assesses a parent's observation of their child's or adolescent's cognitive, affective, and behavioural symptoms of depression. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 2 (much or most of the time). Total raw scores are converted into T-scores with a score of 65 being indicative clinically significant depressive symptoms.
Time frame
Baseline and 1-month follow up3
Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 3 Months
The CDI-2 P assesses a parent's observation of their child's or adolescent's cognitive, affective, and behavioural symptoms of depression. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 2 (much or most of the time). Total raw scores are converted into T-scores with a score of 65 being indicative clinically significant depressive symptoms.
Time frame
Baseline and 3-months follow up4
Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at Week 3-6
The STAI-P assesses state anxiety (i.e., at this present moment) in school children with and without physical symptoms. Items are rated on a 4-point Likert scale reflecting the frequency the anxiety symptom occurs (1 = not at all; 2 = sometimes; 3 = moderately; 4 = very much so). Total scores for the subscales can range from a minimum score of 20 to a maximum score of 80.
Time frame
Baseline and Week 3-6 (post-intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Regina
Lead sponsor
Saskatchewan Health Authority - Regina Area
Collaborator
Provincial Health Services Authority British Columbia
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: