Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work? (iCF-PWR)
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ClinicalTrials.gov Identifier: NCT06020274 |
Recruitment Status :
Not yet recruiting
First Posted : August 31, 2023
Last Update Posted : January 3, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
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Cystic Fibrosis in Children Siblings Mental Health Internet-based Intervention | Behavioral: Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
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. |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource (iCF-PWR) Program: How Does it Work? |
Estimated Study Start Date : | January 1, 2024 |
Estimated Primary Completion Date : | April 30, 2024 |
Estimated Study Completion Date : | April 30, 2024 |
Arm | Intervention/treatment |
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Experimental: iCF-PWR Program
Parents are encouraged to review the program along with their child and then children are encouraged to complete the program 1-2 additional times (or as many times as they like). It is suggested that modules be completed at a rate of 1-2 per week, with program completion ranging from 3-6 weeks. Additional mental health resources are provided at the end of the program.
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Behavioral: Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program
The 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. |
No Intervention: Standard Care
Participants will continue to receive their usual standard care related to CF (i.e., accessing services through their local health authority and CF clinic). 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.
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- Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at Week 3-6 [ Time Frame: Baseline and Week 3-6 (post-intervention) ]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.
- Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at 1 Month [ Time Frame: Baseline and 1-month follow up ]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.
- Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at 3 Months [ Time Frame: Baseline and 3-months follow up ]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.
- Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at Week 3-6 [ Time Frame: Baseline and Week 3-6 (post-intervention) ]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.
- Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at 1 month [ Time Frame: Baseline and 1-month follow up ]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.
- Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at 3 months [ Time Frame: Baseline and 3-months follow up ]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.
- Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at Week 3-6 [ Time Frame: Baseline and Week 3-6 (post-intervention) ]The CIAS assesses fears, beliefs, and attitudes that are associated with health anxiety and abnormal illness behaviour in school children on a continuous scale. Items are rated on a 3-point Likert scale with total scores range from 29 to 87 with higher scores reflecting higher levels of health anxiety associated behaviours.
- Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at 1 month [ Time Frame: Baseline and 1-month follow up ]The CIAS assesses fears, beliefs, and attitudes that are associated with health anxiety and abnormal illness behaviour in school children on a continuous scale. Items are rated on a 3-point Likert scale with total scores range from 29 to 87 with higher scores reflecting higher levels of health anxiety associated behaviours.
- Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at 3 months [ Time Frame: Baseline and 3-months follow up ]The CIAS assesses fears, beliefs, and attitudes that are associated with health anxiety and abnormal illness behaviour in school children on a continuous scale. Items are rated on a 3-point Likert scale with total scores range from 29 to 87 with higher scores reflecting higher levels of health anxiety associated behaviours.
- Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at Week 3-6 [ Time Frame: Baseline and Week 3-6 (post-intervention) ]The PedsQL-4.0 measures health-related quality of life in healthy and acute and chronically ill children and adolescents on a continuous scale. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). The PedsQL-4.0 is comprised of four generic core scales that encompass physical functioning, emotional functioning, social functioning, and school functioning.
- Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at 1 month [ Time Frame: Baseline and 1-month follow up ]The PedsQL-4.0 measures health-related quality of life in healthy and acute and chronically ill children and adolescents on a continuous scale. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). The PedsQL-4.0 is comprised of four generic core scales that encompass physical functioning, emotional functioning, social functioning, and school functioning.
- Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at 3 months [ Time Frame: Baseline and 3-months follow up ]The PedsQL-4.0 measures health-related quality of life in healthy and acute and chronically ill children and adolescents on a continuous scale. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). The PedsQL-4.0 is comprised of four generic core scales that encompass physical functioning, emotional functioning, social functioning, and school functioning.
- Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at Week 3-6 [ Time Frame: Baseline and Week 3-6 (post-intervention) ]The SEQ-C is a 21 item measures designed to assess children's perceptions of their social self-efficacy (ability to relate and get along with other peers), emotional self-efficacy (ability to regulate unpleasant emotions), and academic self-efficacy (ability to succeed in school and display appropriate learning behaviors). The three subscales each contain seven items in which participants rate their competence level on a 5-point Likert-type scale (1 = not at all to 5 = very well). Scores are summed to yield a measure of self-efficacy for each domain.
- Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 1 Month [ Time Frame: Baseline and 1-month follow up ]The SEQ-C is a 21 item measures designed to assess children's perceptions of their social self-efficacy (ability to relate and get along with other peers), emotional self-efficacy (ability to regulate unpleasant emotions), and academic self-efficacy (ability to succeed in school and display appropriate learning behaviors). The three subscales each contain seven items in which participants rate their competence level on a 5-point Likert-type scale (1 = not at all to 5 = very well). Scores are summed to yield a measure of self-efficacy for each domain.
- Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 3 Months [ Time Frame: Baseline and 3-months follow up ]The SEQ-C is a 21 item measures designed to assess children's perceptions of their social self-efficacy (ability to relate and get along with other peers), emotional self-efficacy (ability to regulate unpleasant emotions), and academic self-efficacy (ability to succeed in school and display appropriate learning behaviors). The three subscales each contain seven items in which participants rate their competence level on a 5-point Likert-type scale (1 = not at all to 5 = very well). Scores are summed to yield a measure of self-efficacy for each domain.
- Change from Baseline in the Disease Knowledge Questionnaire at Week 3-6 [ Time Frame: Baseline and Week 3-6 (post-intervention) ]The measure was constructed to assess CF disease knowledge as it related to the iCF-PWR content. It is comprised of 13 items rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Higher scores indicate greater CF disease knowledge.
- Change from Baseline in the Disease Knowledge Questionnaire at 1 Month [ Time Frame: Baseline and 1-month follow up ]The measure was constructed to assess CF disease knowledge as it related to the iCF-PWR content. It is comprised of 13 items rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Higher scores indicate greater CF disease knowledge.
- Change from Baseline in the Disease Knowledge Questionnaire at 3 Months [ Time Frame: Baseline and 3-months follow up ]The measure was constructed to assess CF disease knowledge as it related to the iCF-PWR content. It is comprised of 13 items rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Higher scores indicate greater CF disease knowledge.
- Participants Qualitative Perception of Program Satisfaction at Week 3-6 [ Time Frame: Week 3-6 (post-intervention) ]Six qualitative questions designed to assess participants perception of satisfaction with the iCF-PWR program. The questions directly address perceived strengths, likability, and areas of improvement for the program. Participant responses are qualitative in nature.
- Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at Week 3-6 [ Time Frame: Baseline and Week 3-6 (post-intervention) ]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.
- Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 1 Month [ Time Frame: Baseline and 1-month follow up ]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.
- Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 3 Months [ Time Frame: Baseline and 3-months follow up ]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.
- Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at Week 3-6 [ Time Frame: Baseline and Week 3-6 (post-intervention) ]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.
- Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 1 Month [ Time Frame: Baseline and 1-month follow up ]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.
- Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 3 Months [ Time Frame: Baseline and 3-months follow up ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 8 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020274
Contact: Shelby M Shivak, M.A. | 3065506874 | shivak3s@uregina.ca | |
Contact: Dainelle M Caissie, M.Sc. | danielle.caissie@uregina.ca |
Canada, British Columbia | |
BC Children's Hospital | |
Vancouver, British Columbia, Canada | |
Contact: Mark Chilvers, MRCPCH, MD 604-875-2345 ext 4930 MChilvers@cw.bc.ca | |
Canada, Saskatchewan | |
Saskatchewan Health Authority | |
Regina, Saskatchewan, Canada | |
Contact: Julian Tam, MD (306) 844-1009 julian.tam@saskhealthauthority.ca | |
Sub-Investigator: Niki Asiff, RN |
Principal Investigator: | Kristi D Wright, Ph.D. | University of Regina |
Responsible Party: | University of Regina |
ClinicalTrials.gov Identifier: | NCT06020274 |
Other Study ID Numbers: |
2022-166 |
First Posted: | August 31, 2023 Key Record Dates |
Last Update Posted: | January 3, 2024 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
cystic fibrosis child adolescent siblings |
mental health Internet-based intervention anxiety depression |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |