Cystic Fibrosis Clinical Trial
Official title:
The Development and Evaluation of an Internet-delivered Mental Health Prevention Program for Healthy Child Siblings of Individuals With Cystic Fibrosis
NCT number | NCT06012084 |
Other study ID # | 2021-123 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 6, 2023 |
Est. completion date | April 2024 |
The goal of the clinical trial is to test whether a mental health program that is delivered through the Internet works well for healthy children and adolescents with siblings with cystic fibrosis (CF). The main questions it aims to answer are: - Does the program improve the mental health and quality of life of healthy siblings? - Does the program improve the relationship between healthy children and adolescents and their sibling with CF? - Does the program help healthy siblings learn about CF? Participants will: - Fill out an online survey asking questions about their family and mental health before the program - Complete the online mental health program over five weeks - Fill out a weekly question asking about their mood for 10 weeks - Fill out an online survey asking questions about their family and mental health after the program Healthy children and adolescents with siblings with CF will be compared against themselves. Researchers will compare participants scores before starting the program with their scores during and after completing the program. Researchers hope to develop a program that improves mental health, quality of life, sibling relationships, and knowledge about CF.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | April 2024 |
Est. primary completion date | March 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 child or adolescent sibling with cystic fibrosis - able to speak and read English Exclusion Criteria: - have a severe cognitive impairment or a major comorbid medical or psychiatric illness, as this may have interfered with their ability to participate in the program and evaluation process required for the study. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Regina | Regina | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Regina | Provincial Health Services Authority, Saskatchewan Health Authority - Regina Area |
Canada,
Barlow JH, Ellard DR. The psychosocial well-being of children with chronic disease, their parents and siblings: an overview of the research evidence base. Child Care Health Dev. 2006 Jan;32(1):19-31. doi: 10.1111/j.1365-2214.2006.00591.x. — View Citation
Gallagher JE, Jackson MA, George MH, Lewtas J. Dose-related differences in DNA adduct levels in rodent tissues following skin application of complex mixtures from air pollution sources. Carcinogenesis. 1990 Jan;11(1):63-8. doi: 10.1093/carcin/11.1.63. — View Citation
Giallo R, Gavidia-Payne, S. Evaluation of a family-based intervention for siblings of children with disability or chronic illness. Australian e-Journal for the Advancement of Mental Health. 2008; 7(22).
Hartling L, Milne A, Tjosvold L, Wrightson D, Gallivan J, Newton AS. A systematic review of interventions to support siblings of children with chronic illness or disability. J Paediatr Child Health. 2014 Oct;50(10):E26-38. doi: 10.1111/j.1440-1754.2010.01771.x. Epub 2010 Jun 27. — View Citation
Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12. — View Citation
Kazdin AE. Single-case experimental designs. Evaluating interventions in research and clinical practice. Behav Res Ther. 2019 Jun;117:3-17. doi: 10.1016/j.brat.2018.11.015. Epub 2018 Dec 2. — View Citation
Lobato DJ, Kao BT. Integrated sibling-parent group intervention to improve sibling knowledge and adjustment to chronic illness and disability. J Pediatr Psychol. 2002 Dec;27(8):711-6. doi: 10.1093/jpepsy/27.8.711. — View Citation
O'Haver J, Moore IM, Insel KC, Reed PG, Melnyk BM, Lavoie M. Parental perceptions of risk and protective factors associated with the adaptation of siblings of children with cystic fibrosis. Pediatr Nurs. 2010 Nov-Dec;36(6):284-91; quiz 292. — 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
Vermaes IP, van Susante AM, van Bakel HJ. Psychological functioning of siblings in families of children with chronic health conditions: a meta-analysis. J Pediatr Psychol. 2012 Mar;37(2):166-84. doi: 10.1093/jpepsy/jsr081. Epub 2011 Oct 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mood and Anxiety Rating | Single ratings of self-reported mood and anxiety will be completed ten times over the course of the study. One question will assess mood and one question will assess anxiety using a 3-point Likert scale (0 = none of the time; 1 = some of the time; 2 = a lot of the time) to indicate the frequency of the symptom that day. Ratings will be completed prior to beginning the program (baseline - phase A) and during completion of the program (intervention - phase B). The number of ratings in each phase will vary based on the participant and be distributed equally across the 5-week periods with a minimum of three ratings per phase (i.e., during baseline or intervention). | 10 Weeks | |
Primary | Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) | 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 10 (post-intervention) | |
Primary | Change from Baseline in the Children's Depression Inventory-2 (CDI-2) | 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 10 (post-intervention) | |
Primary | Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) | 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 10 (post-intervention) | |
Primary | Change from Baseline in the Childhood Anxiety Sensitivity Index (CASI) | The CASI measures fear of anxiety-related symptoms in school children on a continuous scale. Each item is rated on a 3-point Likert scale (1 = none; 2 = some; 3 = a lot) with total scores ranging from 18 to 54 and higher scores reflecting higher levels of anxiety sensitivity. | Baseline and Week 10 (post-intervention) | |
Primary | Change from Baseline in the Intolerance of Uncertainty Scale-Revised (IUS-R) | The IUS-R measures intolerance of uncertainty in children on a continuous scale. Items are rated on a 5-point Likert scale ranging from 1 (not at all like me) to 5 (entirely like me). Total scores range from 12 to 60 with higher scores indicating higher levels of IU. | Baseline and Week 10 (post-intervention) | |
Primary | Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) | 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 10 (post-intervention) | |
Primary | Change from Baseline in the Sibling Relationship Questionnaire-Revised (SRQ-R) | The SRQ-Rdesigned to assess children's perceptions of their siblings in areas of Closeness/Intimacy, Power, Conflict, and Rivalry. On a 5-point Likert scale ranging from 1 (hardly at all) to 5 (extremely much) children are asked to rate how well a characteristic describes their relationship with their sibling. Higher scores on each of the scales and factors indicate greater levels of the specified relationship quality in the sibling relationship. | Baseline and Week 10 (post-intervention) | |
Primary | Change from Baseline in the Disease Knowledge Questionnaire | 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 10 (post-intervention) | |
Secondary | Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) | 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 10 (post-intervention) | |
Secondary | Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) | 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 10 (post-intervention) |
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