xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06012084</url>
    </required_header>
    <id_info>
      <org_study_id>2021-123</org_study_id>
      <nct_id>NCT06012084</nct_id>
    </id_info>
    <brief_title>The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis</brief_title>
    <official_title>The Development and Evaluation of an Internet-delivered Mental Health Prevention Program for Healthy Child Siblings of Individuals With Cystic Fibrosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Regina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Saskatchewan Health Authority - Regina Area</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Provincial Health Services Authority</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Regina</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of the clinical trial is to test whether a mental health program that is delivered&#xD;
        through the Internet works well for healthy children and adolescents with siblings with&#xD;
        cystic fibrosis (CF). The main questions it aims to answer are:&#xD;
  &#xD;
          -  Does the program improve the mental health and quality of life of healthy siblings?&#xD;
  &#xD;
          -  Does the program improve the relationship between healthy children and adolescents and&#xD;
             their sibling with CF?&#xD;
  &#xD;
          -  Does the program help healthy siblings learn about CF?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Fill out an online survey asking questions about their family and mental health before&#xD;
             the program&#xD;
  &#xD;
          -  Complete the online mental health program over five weeks&#xD;
  &#xD;
          -  Fill out a weekly question asking about their mood for 10 weeks&#xD;
  &#xD;
          -  Fill out an online survey asking questions about their family and mental health after&#xD;
             the program&#xD;
  &#xD;
        Healthy children and adolescents with siblings with CF will be compared against themselves.&#xD;
        Researchers will compare participants scores before starting the program with their scores&#xD;
        during and after completing the program. Researchers hope to develop a program that improves&#xD;
        mental health, quality of life, sibling relationships, and knowledge about CF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        BACKGROUND: Healthy siblings of individuals with chronic illnesses, such as with cystic&#xD;
        fibrosis (CF), have been shown to experience elevated psychological symptoms (e.g.,&#xD;
        depression, anxiety), negative psychological adjustment, and internalizing behaviours.&#xD;
        Psychoeducation, sibling-oriented care, and involvement in siblings' treatments have&#xD;
        demonstrated positive outcomes for siblings in terms of psychological wellbeing, social&#xD;
        support, and quality of life. At present, there are currently no tailored mental health&#xD;
        programs for healthy siblings of individuals with CF. Despite these advances, there is&#xD;
        currently no specific mental health program designed for healthy siblings of individuals with&#xD;
        CF in Canada. One viable and appealing option for the delivery of mental health services that&#xD;
        would eliminate several of the barriers encountered in face-to-face methods of service&#xD;
        delivery (e.g., travel to access care, financial restrictions) is through the Internet.&#xD;
        Support exists for the effectiveness and efficacy of Internet-delivered psychological&#xD;
        treatments for healthy children and children with a range of acute and chronic health&#xD;
        conditions. As such, an Internet-delivered method of mental health service delivery designed&#xD;
        to target the specific needs of healthy siblings of individuals with CF may be beneficial.&#xD;
        The overall goal of the project is to evaluate a recently developed evidence-based,&#xD;
        Internet-delivered mental health prevention program for families with CF [called the&#xD;
        Internet-Delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource program&#xD;
        (iCF-PWR)] living in Saskatchewan, that may be helpful in improving mental health and quality&#xD;
        of life.&#xD;
  &#xD;
        PARTICIPANTS: Six children (aged 8 to 12 years) with CF will be recruited from CF clinics and&#xD;
        CF chapters in Canada. Research ethics approval has been approved in those respective health&#xD;
        care institutions.&#xD;
  &#xD;
        METHODS/PROCEDURES: Preliminary parent consent will be obtained over the phone. A web link&#xD;
        (using Qualtrics) to an informed consent/assent form, demographics form, and questionnaires&#xD;
        (i.e., measures of CF health, anxiety, depression, health anxiety, anxiety sensitivity,&#xD;
        intolerance of uncertainty, quality of life, disease knowledge, and perception of their&#xD;
        sibling relationship) will be e-mailed to parent caregiver. The parent caregiver will help&#xD;
        facilitate the child's completion of questionnaires online using Qualtrics, a web-based&#xD;
        survey software that enables a user-friendly model of conducting surveys. Parents will also&#xD;
        complete two questionnaires about the healthy sibling's anxiety, and depression symptoms.&#xD;
        Completion of the questionnaires will take approximately one hour. These measures will be&#xD;
        completed again upon completion of the program. A link to the post-program questionnaires&#xD;
        will be provided via email to parent caregivers to be completed after the program has been&#xD;
        completed by the child. Child participants will be also asked to complete a series of&#xD;
        one-item ratings of mood and anxiety prior to beginning the program (i.e., phase A) and&#xD;
        during completion of the program (i.e., phase B) using Qualtrics. Each phase of the study&#xD;
        will be approximately five weeks in length.&#xD;
  &#xD;
        Once enrolled, parent caregivers will be provided with a username/password. Participants will&#xD;
        be instructed to keep their username/password private. A contact e-mail of the research&#xD;
        coordinator will be provided for technical support and instructions on how to operate the&#xD;
        site. All contact with participants will be via e-mail, although a telephone number for the&#xD;
        research coordinator will also be provided. Supervision of contact with child participants&#xD;
        and parent caregivers will be provided by the research supervisor (i.e., Dr. Kristi Wright).&#xD;
        Informatics of participant use of the program will be collected (e.g., amount of time spent&#xD;
        completing each module, program completion time). Participants will be encouraged to complete&#xD;
        one module per week. A reminder e-mail will be sent to parents if their child has not logged&#xD;
        onto the program at least once per week. Participants will also be sent email reminders on&#xD;
        the days they have been scheduled to complete a rating of mood and anxiety.&#xD;
  &#xD;
        ANALYSES: Statistical analyses will be performed using IBM SPSS Statistics-Version 25. Visual&#xD;
        analyses are the primary analyses used to determine whether there may be a functional (i.e.,&#xD;
        three demonstrations of the effectiveness of the intervention effect) or causal relationship&#xD;
        between the intervention and the outcome variables. Visual analysis refers to reaching a&#xD;
        judgment about the reliability or consistency of an intervention's effects by visually&#xD;
        examining the graphed data. The program's effectiveness will be evaluated primarily by&#xD;
        examining the changes between baseline (phase A) and post-program (phase B) measures, in&#xD;
        addition to changes across the repeated momentary mood and anxiety measure. Baseline and&#xD;
        post-program measures and the mood and anxiety ratings will be presented graphically to&#xD;
        enable visual inspection. The visual inspection of data will also include analyzing trends in&#xD;
        change over time and changes in variability of outcome measures.&#xD;
  &#xD;
        If the data suggests a functional or causal relationship may be present, the visual analyses&#xD;
        will be supplement with a quantitative analysis method evaluating the magnitude of the&#xD;
        intervention effect. Descriptive statistics will be computed for total scores from the&#xD;
        outcome measures. Healthy siblings' baseline and post-program total scores from the measure&#xD;
        of interest will also be compared to existing community and/or normative data. A series of&#xD;
        independent sample t-tests will be computed to compare healthy siblings to similar aged&#xD;
        children to assess for potential differences across samples. To evaluate the magnitude of&#xD;
        change in outcomes measures from baseline and post-program, a Reliable Change Index (RCI)&#xD;
        will be calculated as an indicator of clinically significant change. The RCI will be&#xD;
        calculated for each participant by taking their pre-test and post-test total scores and&#xD;
        dividing it by the standard error of the difference.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single-case experimental design (SCED), across-participant AB design. Randomized phase-order will be used in that the start point of the intervention phase will be randomized across participants.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Mood and Anxiety Rating</measure>
      <time_frame>10 Weeks</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C)</measure>
      <time_frame>Baseline and Week 10 (post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the Children's Depression Inventory-2 (CDI-2)</measure>
      <time_frame>Baseline and Week 10 (post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the Childhood Illness Attitudes Scale (CIAS)</measure>
      <time_frame>Baseline and Week 10 (post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the Childhood Anxiety Sensitivity Index (CASI)</measure>
      <time_frame>Baseline and Week 10 (post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the Intolerance of Uncertainty Scale-Revised (IUS-R)</measure>
      <time_frame>Baseline and Week 10 (post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0)</measure>
      <time_frame>Baseline and Week 10 (post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the Sibling Relationship Questionnaire-Revised (SRQ-R)</measure>
      <time_frame>Baseline and Week 10 (post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the Disease Knowledge Questionnaire</measure>
      <time_frame>Baseline and Week 10 (post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P)</measure>
      <time_frame>Baseline and Week 10 (post-intervention)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P)</measure>
      <time_frame>Baseline and Week 10 (post-intervention)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Cystic Fibrosis</condition>
    <condition>Siblings</condition>
    <condition>Mental Health</condition>
    <condition>Internet-based Intervention</condition>
    <arm_group>
      <arm_group_label>iCF-PWR Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program is comprised of five text/voice-delivered, animated, interactive modules. The pathways are comprised of the same modules that take approximately 15 to 20 minutes to complete. Modules are comprised of web pages and/or screens with numerous illustrations and interactive components. Written module content will be presented verbally as well as in text format.&#xD;
  The program modules include: (1) What is CF? (i.e., physiological explanation of CF, prevalence rate); (2) How does my sibling with CF stay healthy? (i.e., review of medication, nutrition, physiotherapy treatment, and why treatment is important); (3) How does CF affect me?; (4) Mental health awareness (i.e., introduction to cognitive behaviour model of emotions-thoughts, feelings, bodily sensations, and behaviours); and (5) Strategies (i.e., ways to challenge unhelpful thoughts, talking about emotions, relaxation).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program</intervention_name>
      <description>The iCF-PWR program is a self-guided mental health prevention program designed for families with CF.</description>
      <arm_group_label>iCF-PWR Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  between the ages of 8 and 12&#xD;
  &#xD;
            -  have a child or adolescent sibling with cystic fibrosis&#xD;
  &#xD;
            -  able to speak and read English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  have a severe cognitive impairment or a major comorbid medical or psychiatric illness,&#xD;
               as this may have interfered with their ability to participate in the program and&#xD;
               evaluation process required for the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kristi D Wright, Ph.D</last_name>
      <role>Study Director</role>
      <affiliation>University of Regina</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shelby M Shivak, M.A.</last_name>
      <phone>3065506874</phone>
      <email>shivak3s@uregina.ca</email>
    </overall_contact>
    <reference>
      <citation>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.</citation>
      <PMID>16398788</PMID>
    </reference>
    <reference>
      <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).</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>20598075</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>12403861</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>21291044</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>26452630</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>2403860</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>21994420</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>30527785</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>2002127</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cystic fibrosis</keyword>
    <keyword>siblings</keyword>
    <keyword>mental health</keyword>
    <keyword>child</keyword>
    <keyword>adolescent</keyword>
    <keyword>sibling relations</keyword>
    <keyword>Internet-based intervention</keyword>
    <keyword>anxiety</keyword>
    <keyword>depression</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cystic Fibrosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06012084
  org study id: 2021-123
  nct id: NCT06012084
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  BACKGROUND: Healthy siblings of individuals with chronic illnesses, such as with cystic
        fibrosis (CF), have been shown to experience elevated psychological symptoms (e.g.,
        depression, anxiety), negative psychological adjustment, and internalizing behaviours.
        Psychoeducation, sibling-oriented care, and involvement in siblings' treatments have
        demonstrated positive outcomes for siblings in terms of psychological wellbeing, social
        support, and quality of life. At present, there are currently no tailored mental health
        programs for healthy siblings of individuals with CF. Despite these advances, there is
        currently no specific mental health program designed for healthy siblings of individuals with
        CF in Canada. One viable and appealing option for the delivery of mental health services that
        would eliminate several of the barriers encountered in face-to-face methods of service
        delivery (e.g., travel to access care, financial restrictions) is through the Internet.
        Support exists for the effectiveness and efficacy of Internet-delivered psychological
        treatments for healthy children and children with a range of acute and chronic health
        conditions. As such, an Internet-delivered method of mental health service delivery designed
        to target the specific needs of healthy siblings of individuals with CF may be beneficial.
        The overall goal of the project is to evaluate a recently developed evidence-based,
        Internet-delivered mental health prevention program for families with CF [called the
        Internet-Delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource program
        (iCF-PWR)] living in Saskatchewan, that may be helpful in improving mental health and quality
        of life.
  
        PARTICIPANTS: Six children (aged 8 to 12 years) with CF will be recruited from CF clinics and
        CF chapters in Canada. Research ethics approval has been approved in those respective health
        care institutions.
  
        METHODS/PROCEDURES: Preliminary parent consent will be obtained over the phone. A web link
        (using Qualtrics) to an informed consent/assent form, demographics form, and questionnaires
        (i.e., measures of CF health, anxiety, depression, health anxiety, anxiety sensitivity,
        intolerance of uncertainty, quality of life, disease knowledge, and perception of their
        sibling relationship) will be e-mailed to parent caregiver. The parent caregiver will help
        facilitate the child's completion of questionnaires online using Qualtrics, a web-based
        survey software that enables a user-friendly model of conducting surveys. Parents will also
        complete two questionnaires about the healthy sibling's anxiety, and depression symptoms.
        Completion of the questionnaires will take approximately one hour. These measures will be
        completed again upon completion of the program. A link to the post-program questionnaires
        will be provided via email to parent caregivers to be completed after the program has been
        completed by the child. Child participants will be also asked to complete a series of
        one-item ratings of mood and anxiety prior to beginning the program (i.e., phase A) and
        during completion of the program (i.e., phase B) using Qualtrics. Each phase of the study
        will be approximately five weeks in length.
  
        Once enrolled, parent caregivers will be provided with a username/password. Participants will
        be instructed to keep their username/password private. A contact e-mail of the research
        coordinator will be provided for technical support and instructions on how to operate the
        site. All contact with participants will be via e-mail, although a telephone number for the
        research coordinator will also be provided. Supervision of contact with child participants
        and parent caregivers will be provided by the research supervisor (i.e., Dr. Kristi Wright).
        Informatics of participant use of the program will be collected (e.g., amount of time spent
        completing each module, program completion time). Participants will be encouraged to complete
        one module per week. A reminder e-mail will be sent to parents if their child has not logged
        onto the program at least once per week. Participants will also be sent email reminders on
        the days they have been scheduled to complete a rating of mood and anxiety.
  
        ANALYSES: Statistical analyses will be performed using IBM SPSS Statistics-Version 25. Visual
        analyses are the primary analyses used to determine whether there may be a functional (i.e.,
        three demonstrations of the effectiveness of the intervention effect) or causal relationship
        between the intervention and the outcome variables. Visual analysis refers to reaching a
        judgment about the reliability or consistency of an intervention's effects by visually
        examining the graphed data. The program's effectiveness will be evaluated primarily by
        examining the changes between baseline (phase A) and post-program (phase B) measures, in
        addition to changes across the repeated momentary mood and anxiety measure. Baseline and
        post-program measures and the mood and anxiety ratings will be presented graphically to
        enable visual inspection. The visual inspection of data will also include analyzing trends in
        change over time and changes in variability of outcome measures.
  
        If the data suggests a functional or causal relationship may be present, the visual analyses
        will be supplement with a quantitative analysis method evaluating the magnitude of the
        intervention effect. Descriptive statistics will be computed for total scores from the
        outcome measures. Healthy siblings' baseline and post-program total scores from the measure
        of interest will also be compared to existing community and/or normative data. A series of
        independent sample t-tests will be computed to compare healthy siblings to similar aged
        children to assess for potential differences across samples. To evaluate the magnitude of
        change in outcomes measures from baseline and post-program, a Reliable Change Index (RCI)
        will be calculated as an indicator of clinically significant change. The RCI will be
        calculated for each participant by taking their pre-test and post-test total scores and
        dividing it by the standard error of the difference.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single-case experimental design (SCED), across-participant AB design. Randomized phase-order will be used in that the start point of the intervention phase will be randomized across participants.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in Mood and Anxiety Rating
  time frame: 10 Weeks
  description: 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).
  measure: Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C)
  time frame: Baseline and Week 10 (post-intervention)
  description: 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.
  measure: Change from Baseline in the Children's Depression Inventory-2 (CDI-2)
  time frame: Baseline and Week 10 (post-intervention)
  description: 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.
  measure: Change from Baseline in the Childhood Illness Attitudes Scale (CIAS)
  time frame: Baseline and Week 10 (post-intervention)
  description: 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.
  measure: Change from Baseline in the Childhood Anxiety Sensitivity Index (CASI)
  time frame: Baseline and Week 10 (post-intervention)
  description: 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.
  measure: Change from Baseline in the Intolerance of Uncertainty Scale-Revised (IUS-R)
  time frame: Baseline and Week 10 (post-intervention)
  description: 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.
  measure: Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0)
  time frame: Baseline and Week 10 (post-intervention)
  description: 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.
  measure: Change from Baseline in the Sibling Relationship Questionnaire-Revised (SRQ-R)
  time frame: Baseline and Week 10 (post-intervention)
  description: 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.
  measure: Change from Baseline in the Disease Knowledge Questionnaire
  time frame: Baseline and Week 10 (post-intervention)
  description: 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.
  measure: Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P)
  time frame: Baseline and Week 10 (post-intervention)
  description: 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.
  measure: Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P)
  time frame: Baseline and Week 10 (post-intervention)
  description: 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.
  arm group label: iCF-PWR Intervention
  arm group type: Experimental
  description: Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program is comprised of five text/voice-delivered, animated, interactive modules. The pathways are comprised of the same modules that take approximately 15 to 20 minutes to complete. Modules are comprised of web pages and/or screens with numerous illustrations and interactive components. Written module content will be presented verbally as well as in text format.
  The program modules include: (1) What is CF? (i.e., physiological explanation of CF, prevalence rate); (2) How does my sibling with CF stay healthy? (i.e., review of medication, nutrition, physiotherapy treatment, and why treatment is important); (3) How does CF affect me?; (4) Mental health awareness (i.e., introduction to cognitive behaviour model of emotions-thoughts, feelings, bodily sensations, and behaviours); and (5) Strategies (i.e., ways to challenge unhelpful thoughts, talking about emotions, relaxation).
  intervention type: Behavioral
  intervention name: Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program
  description: The iCF-PWR program is a self-guided mental health prevention program designed for families with CF.
  arm group label: iCF-PWR Intervention
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Kristi D Wright, Ph.D
  role: Study Director
  affiliation: University of Regina
  last name: Shelby M Shivak, M.A.
  phone: 3065506874
  email: shivak3s@uregina.ca
  citation: 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.
  PMID: 16398788
  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).
  citation: 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.
  PMID: 20598075
  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.
  PMID: 12403861
  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.
  PMID: 21291044
  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.
  PMID: 26452630
  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.
  PMID: 2403860
  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.
  PMID: 21994420
  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.
  PMID: 30527785
  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.
  PMID: 2002127
  responsible party type: Sponsor
  mesh term: Cystic Fibrosis
  mesh term: Fibrosis
  sharing ipd: No