Mental Health Clinical Trial
— iCF-PWROfficial 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? 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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Saskatchewan Health Authority | Regina | Saskatchewan |
Canada | BC Children's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of Regina | Provincial Health Services Authority, Saskatchewan Health Authority - Regina Area |
Canada,
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. — View Citation
Elborn JS. Cystic fibrosis. Lancet. 2016 Nov 19;388(10059):2519-2531. doi: 10.1016/S0140-6736(16)00576-6. Epub 2016 Apr 29. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Kovacs M. Children's depression inventory-2. New York: Multi-Health System. 2011.
Miles M, Huberman M. An Expanded Source Book: Qualitative Data Analysis. California: Sage Publications. 1994.
Morse J, Field P. Qualitative research methods for health professionals. California: Sage Publications. 2005.
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. — View Citation
Muris P. A brief questionnaire for measuring self-efficacy in youths. J Psychopathol Behav Assess 2001;23:145-49.
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.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Spielberger CD, Edwards CD, Montuori J, et al. State-Trait Anxiety Inventory for Children. Palo Alto, CA: Consulting Psychologist Press;1973.
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. — View Citation
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. — View Citation
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.
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | Baseline and Week 3-6 (post-intervention) | |
Secondary | 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. | Baseline and 1-month follow up | |
Secondary | 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. | Baseline and 3-months follow up | |
Secondary | 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. | Baseline and Week 3-6 (post-intervention) | |
Secondary | 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. | Baseline and 1-month follow up | |
Secondary | 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. | Baseline and 3-months follow up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT04108689 -
Internet-based Acceptance and Commitment Training for Elite Ice Hockey Players
|
N/A | |
Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
Completed |
NCT04085861 -
Mental Health in Dancers; an Intervention Study
|
N/A | |
Recruiting |
NCT05227352 -
Bio-Experiential Spaces for Mental Health in Healthworkers
|
N/A | |
Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
Completed |
NCT02480907 -
Supporting Carers of Children and Adolescents With Eating Disorders in Austria (SUCCEAT)
|
N/A | |
Completed |
NCT02157766 -
Wisconsin Center for the Neuroscience and Psychophysiology of Meditation
|
N/A | |
Completed |
NCT01155687 -
Psychosocial Counseling in Afghanistan
|
N/A | |
Unknown status |
NCT01177696 -
Intervention in Groups of Family Caregivers in Primary Health Care
|
N/A | |
Completed |
NCT01037946 -
Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families
|
N/A | |
Completed |
NCT00700349 -
Evaluation of Impacts of Access to Credit and Loan Size for Microcredit Clients in South Africa
|
N/A | |
Recruiting |
NCT03885401 -
Enhanced Care Planning for Patients With Multiple Chronic Conditions
|
N/A | |
Completed |
NCT03118388 -
Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs
|
Phase 2 | |
Completed |
NCT05061966 -
The Digital Wellbeing Project
|
N/A | |
Completed |
NCT04026308 -
Written vs Electronic Safety Planning Study
|
N/A | |
Completed |
NCT04546061 -
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
|
N/A | |
Completed |
NCT05738109 -
Evaluating the Efficacy of a 91-day Self-talk Mental Health Self-care Journal
|
N/A | |
Completed |
NCT03901274 -
Partnering for Student Wellness
|
N/A | |
Not yet recruiting |
NCT05910580 -
Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
|
N/A |