Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work?

NCT06020274 | Not Yet Recruiting

• 1 other identifier: 2022-166
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis in Children; Siblings; Mental Health; Internet-based Intervention

Keywords

cystic fibrosis; child; adolescent; siblings; mental health; Internet-based intervention; anxiety; depression

Outcome Measures

Primary Outcomes (19)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  Baseline and 1-month follow up

• Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 3 Months

  Baseline and 3-months follow up

• Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at Week 3-6

  Baseline and Week 3-6 (post-intervention)

• Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 1 Month

  Baseline and 1-month follow up

Study Arms (2)

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.

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.

Interventions

Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program BEHAVIORAL

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.

iCF-PWR Program

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regina: lead
• Saskatchewan Health Authority - Regina Area: collaborator
• Provincial Health Services Authority British Columbia: collaborator

Study Sites (2)

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

Saskatchewan Health Authority

Regina, Saskatchewan, Canada

Location

Related Publications (20)

• 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.

  PMID: 25246663 BACKGROUND

• Quittner 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.

  PMID: 26452630 BACKGROUND

• Jamieson 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.

  PMID: 24843053 BACKGROUND

• Elborn JS. Cystic fibrosis. Lancet. 2016 Nov 19;388(10059):2519-2531. doi: 10.1016/S0140-6736(16)00576-6. Epub 2016 Apr 29.

  PMID: 27140670 BACKGROUND

• Smith 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.

  PMID: 27662107 BACKGROUND

• Goldbeck 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.

  PMID: 24941199 BACKGROUND

• Pinquart 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.

  PMID: 21088072 BACKGROUND

• Fauman 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.

  PMID: 21454321 BACKGROUND

• Moussavi 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.

  PMID: 17826170 BACKGROUND

• Barrett 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.

  PMID: 16836477 BACKGROUND

• O'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.

  BACKGROUND

• 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.

  BACKGROUND

• Spielberger CD, Edwards CD, Montuori J, et al. State-Trait Anxiety Inventory for Children. Palo Alto, CA: Consulting Psychologist Press;1973.

  BACKGROUND

• Kovacs M. Children's depression inventory-2. New York: Multi-Health System. 2011.

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• 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.

  PMID: 16291551 BACKGROUND

• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.

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• Muris P. A brief questionnaire for measuring self-efficacy in youths. J Psychopathol Behav Assess 2001;23:145-49.

  BACKGROUND

• Shain LM, Pao M, Tipton MV, Bedoya SZ, Kang SJ, Horowitz LM, Wiener L. Comparing Parent and Child Self-report Measures of the State-Trait Anxiety Inventory in Children and Adolescents with a Chronic Health Condition. J Clin Psychol Med Settings. 2020 Mar;27(1):173-181. doi: 10.1007/s10880-019-09631-5.

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• Miles M, Huberman M. An Expanded Source Book: Qualitative Data Analysis. California: Sage Publications. 1994.

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  BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Cystic Fibrosis; Anxiety Disorders; Depression

Interventions

Health; Health Resources

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Kristi D Wright, Ph.D.

  University of Regina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelby M Shivak, M.A.

CONTACT

3065506874; shivak3s@uregina.ca

Dainelle M Caissie, M.Sc.

CONTACT

danielle.caissie@uregina.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: June 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)