Cystic Fibrosis in ChildreniCF-PWRNCT06020274
Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work?
A study testing Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program in people with Cystic Fibrosis in Children and Siblings, run by University of Regina at 2 sites in Canada.
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 children and adolescents with cystic fibrosis (CF) and their healthy siblings. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cystic Fibrosis in Children, Siblings, Mental Health
- What is being tested?
- Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dainelle M Caissie, M.Sc. contact
Canada2 sites
Saskatchewan Health Authority
Regina, Saskatchewan
Julian Tam, MD, (306) 844-1009, julian.tam@saskhealthauthority.ca
Niki Asiff, RN
BC Children's Hospital
Vancouver, British Columbia
Mark Chilvers, MRCPCH, MD, 604-875-2345 ext. 4930, MChilvers@cw.bc.ca
About this study
Official title: Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource (iCF-PWR) Program: How Does it Work?
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?
Read more
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.
Read the 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:
- 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.
- 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.
- 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.
- 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.
- 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).
- Being tested
- Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program
- Keywords
- cystic fibrosis, child, adolescent, siblings, mental health, Internet-based intervention, anxiety, depression
- Medical subject headings
- Psychological Well-Being, Cystic Fibrosis, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iCF-PWR Program | Experimental | 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. Receives: Behavioral: Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program |
| Standard Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 3-6 (post-intervention)
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.
Measured: Baseline and 1-month follow up
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.
Measured: Baseline and 3-months follow up
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.
Measured: Baseline and Week 3-6 (post-intervention)
Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at 1 month
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.
Measured: Baseline and 1-month follow up
Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at 3 months
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.
Measured: Baseline and 3-months follow up
Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at Week 3-6
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.
Measured: Baseline and Week 3-6 (post-intervention)
Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at 1 month
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.
Measured: Baseline and 1-month follow up
Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at 3 months
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.
Measured: Baseline and 3-months follow up
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at Week 3-6
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.
Measured: Baseline and Week 3-6 (post-intervention)
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at 1 month
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.
Measured: Baseline and 1-month follow up
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at 3 months
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.
Measured: Baseline and 3-months follow up
Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at Week 3-6
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.
Measured: Baseline and Week 3-6 (post-intervention)
Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 1 Month
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.
Measured: Baseline and 1-month follow up
Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 3 Months
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.
Measured: Baseline and 3-months follow up
Change from Baseline in the Disease Knowledge Questionnaire at Week 3-6
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.
Measured: Baseline and Week 3-6 (post-intervention)
Change from Baseline in the Disease Knowledge Questionnaire at 1 Month
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.
Measured: Baseline and 1-month follow up
Change from Baseline in the Disease Knowledge Questionnaire at 3 Months
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.
Measured: Baseline and 3-months follow up
Participants Qualitative Perception of Program Satisfaction at Week 3-6
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.
Measured: Week 3-6 (post-intervention)
Secondary outcomes (6)
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.
Measured: Baseline and Week 3-6 (post-intervention)
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.
Measured: Baseline and 1-month follow up
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.
Measured: Baseline and 3-months follow up
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.
Measured: Baseline and Week 3-6 (post-intervention)
Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 1 Month
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.
Measured: Baseline and 1-month follow up
Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 3 Months
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.
Measured: Baseline and 3-months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Jun 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Authority - Regina Area, Provincial Health Services Authority British Columbia
- Responsible party
- Sponsor
- Investigators
- Kristi D Wright, Ph.D., Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020274
- Sponsor's protocol ID
- 2022-166
- Acronym
- iCF-PWR
- Status last verified
- May 2025
- First submitted
- 25 Aug 2023
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quittner AL, Goldbeck L, Abbott J, Duff A, Lambrecht P, Sole A, Tibosch MM, Bergsten Brucefors A, Yuksel H, Catastini P, Blackwell L, Barker D. Prevalence of depression and anxiety in patients with cystic fibrosis and parent caregivers: results of The International Depression Epidemiological Study across nine countries. Thorax. 2014 Dec;69(12):1090-7. doi: 10.1136/thoraxjnl-2014-205983. Epub 2014 Sep 21.
PubMed 25246663Quittner AL, Abbott J, Georgiopoulos AM, Goldbeck L, Smith B, Hempstead SE, Marshall B, Sabadosa KA, Elborn S; International Committee on Mental Health; EPOS Trial Study Group. International Committee on Mental Health in Cystic Fibrosis: Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus statements for screening and treating depression and anxiety. Thorax. 2016 Jan;71(1):26-34. doi: 10.1136/thoraxjnl-2015-207488. Epub 2015 Oct 9.
PubMed 26452630Jamieson N, Fitzgerald D, Singh-Grewal D, Hanson CS, Craig JC, Tong A. Children's experiences of cystic fibrosis: a systematic review of qualitative studies. Pediatrics. 2014 Jun;133(6):e1683-97. doi: 10.1542/peds.2014-0009.
PubMed 24843053Elborn JS. Cystic fibrosis. Lancet. 2016 Nov 19;388(10059):2519-2531. doi: 10.1016/S0140-6736(16)00576-6. Epub 2016 Apr 29.
PubMed 27140670Smith BA, Georgiopoulos AM, Quittner AL. Maintaining mental health and function for the long run in cystic fibrosis. Pediatr Pulmonol. 2016 Oct;51(S44):S71-S78. doi: 10.1002/ppul.23522.
PubMed 27662107Goldbeck L, Fidika A, Herle M, Quittner AL. Psychological interventions for individuals with cystic fibrosis and their families. Cochrane Database Syst Rev. 2014 Jun 18;2014(6):CD003148. doi: 10.1002/14651858.CD003148.pub3.
PubMed 24941199Pinquart M, Shen Y. Depressive symptoms in children and adolescents with chronic physical illness: an updated meta-analysis. J Pediatr Psychol. 2011 May;36(4):375-84. doi: 10.1093/jpepsy/jsq104. Epub 2010 Nov 18.
PubMed 21088072Fauman KR, Pituch KJ, Han YY, Niedner MF, Reske J, LeVine AM. Predictors of depressive symptoms in parents of chronically ill children admitted to the pediatric intensive care unit. Am J Hosp Palliat Care. 2011 Dec;28(8):556-63. doi: 10.1177/1049909111403465. Epub 2011 Mar 30.
PubMed 21454321Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet. 2007 Sep 8;370(9590):851-8. doi: 10.1016/S0140-6736(07)61415-9.
PubMed 17826170Barrett PM, Farrell LJ, Ollendick TH, Dadds M. Long-term outcomes of an Australian universal prevention trial of anxiety and depression symptoms in children and youth: an evaluation of the friends program. J Clin Child Adolesc Psychol. 2006 Sep;35(3):403-11. doi: 10.1207/s15374424jccp3503_5.
PubMed 16836477O'Donohue WT, Draper C. The case for evidence-based stepped care as part of a reformed delivery system. In Draper C, O'Donohue WT (Eds), Stepped Care and e-Health. Practical Applications to Behavioral Disorders.Springer:1-16.
Wright KD, Switzer H, Power HA et al. Canadian research: Mental health needs of children and adolescents with CF, and their families. Presented at the Western Canadian Cystic Fibrosis Conference, Saskatoon, SK, 2020, September.
Spielberger CD, Edwards CD, Montuori J, et al. State-Trait Anxiety Inventory for Children. Palo Alto, CA: Consulting Psychologist Press;1973.
Kovacs M. Children's depression inventory-2. New York: Multi-Health System. 2011.
Wright KD, Asmundson GJ. Health anxiety in children: development and psychometric properties of the Childhood Illness Attitude Scales. Cogn Behav Ther. 2003;32(4):194-202. doi: 10.1080/16506070310014691.
PubMed 16291551
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource (iCF-PWR) Program: How Does it Work?
- ClinicalTrials.gov ID
- NCT06020274
- Acronym / sponsor ID
- iCF-PWR / 2022-166
- Keywords
- cystic fibrosis, child, adolescent, siblings, mental health, Internet-based intervention, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Saskatchewan Health Authority - Regina Area, Provincial Health Services Authority British Columbia
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| iCF-PWR Program | Experimental | Behavioral: Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) programParents 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. |
| Standard Care | No intervention | –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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) programThe 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. | Behavioural | iCF-PWR Program |
Primary outcome
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.
6 secondary outcomes
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)
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
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
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)
Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 1 Month
Time frame: Baseline and 1-month follow up
Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 3 Months
Time frame: Baseline and 3-months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 25246663Quittner AL, Goldbeck L, Abbott J, Duff A, Lambrecht P, Sole A, Tibosch MM, Bergsten Brucefors A, Yuksel H, Catastini P, Blackwell L, Barker D. Prevalence of depression and anxiety in patients with cystic fibrosis and parent caregivers: results of The International Depression Epidemiological Study across nine countries. Thorax. 2014 Dec;69(12):1090-7. doi: 10.1136/thoraxjnl-2014-205983. Epub 2014 Sep 21.
- Background: PubMed 26452630Quittner AL, Abbott J, Georgiopoulos AM, Goldbeck L, Smith B, Hempstead SE, Marshall B, Sabadosa KA, Elborn S; International Committee on Mental Health; EPOS Trial Study Group. International Committee on Mental Health in Cystic Fibrosis: Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus statements for screening and treating depression and anxiety. Thorax. 2016 Jan;71(1):26-34. doi: 10.1136/thoraxjnl-2015-207488. Epub 2015 Oct 9.
- Background: PubMed 24843053Jamieson N, Fitzgerald D, Singh-Grewal D, Hanson CS, Craig JC, Tong A. Children's experiences of cystic fibrosis: a systematic review of qualitative studies. Pediatrics. 2014 Jun;133(6):e1683-97. doi: 10.1542/peds.2014-0009.
- Background: PubMed 27140670Elborn JS. Cystic fibrosis. Lancet. 2016 Nov 19;388(10059):2519-2531. doi: 10.1016/S0140-6736(16)00576-6. Epub 2016 Apr 29.
- Background: PubMed 27662107Smith BA, Georgiopoulos AM, Quittner AL. Maintaining mental health and function for the long run in cystic fibrosis. Pediatr Pulmonol. 2016 Oct;51(S44):S71-S78. doi: 10.1002/ppul.23522.
- Background: PubMed 24941199Goldbeck L, Fidika A, Herle M, Quittner AL. Psychological interventions for individuals with cystic fibrosis and their families. Cochrane Database Syst Rev. 2014 Jun 18;2014(6):CD003148. doi: 10.1002/14651858.CD003148.pub3.
- Background: PubMed 21088072Pinquart M, Shen Y. Depressive symptoms in children and adolescents with chronic physical illness: an updated meta-analysis. J Pediatr Psychol. 2011 May;36(4):375-84. doi: 10.1093/jpepsy/jsq104. Epub 2010 Nov 18.
- Background: PubMed 21454321Fauman KR, Pituch KJ, Han YY, Niedner MF, Reske J, LeVine AM. Predictors of depressive symptoms in parents of chronically ill children admitted to the pediatric intensive care unit. Am J Hosp Palliat Care. 2011 Dec;28(8):556-63. doi: 10.1177/1049909111403465. Epub 2011 Mar 30.
- Background: PubMed 17826170Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet. 2007 Sep 8;370(9590):851-8. doi: 10.1016/S0140-6736(07)61415-9.
- Background: PubMed 16836477Barrett PM, Farrell LJ, Ollendick TH, Dadds M. Long-term outcomes of an Australian universal prevention trial of anxiety and depression symptoms in children and youth: an evaluation of the friends program. J Clin Child Adolesc Psychol. 2006 Sep;35(3):403-11. doi: 10.1207/s15374424jccp3503_5.
- BackgroundO'Donohue WT, Draper C. The case for evidence-based stepped care as part of a reformed delivery system. In Draper C, O'Donohue WT (Eds), Stepped Care and e-Health. Practical Applications to Behavioral Disorders.Springer:1-16.
- BackgroundWright KD, Switzer H, Power HA et al. Canadian research: Mental health needs of children and adolescents with CF, and their families. Presented at the Western Canadian Cystic Fibrosis Conference, Saskatoon, SK, 2020, September.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dainelle M Caissie, M.Sc. contact
Kristi D Wright, Ph.D. principal investigator
University of Regina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program in people with Cystic Fibrosis in Children and Siblings, run by University of Regina at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shelby M Shivak, M.A. (3065506874, shivak3s@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06020274, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.