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/NCT06020274</url>
    </required_header>
    <id_info>
      <org_study_id>2022-166</org_study_id>
      <nct_id>NCT06020274</nct_id>
    </id_info>
    <brief_title>Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work?</brief_title>
    <acronym>iCF-PWR</acronym>
    <official_title>Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource (iCF-PWR) Program: How Does it Work?</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 children and adolescents with cystic fibrosis (CF) and&#xD;
        their healthy siblings. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Does the program improve the mental health such as depression and anxiety symptoms?&#xD;
  &#xD;
          -  Does the program improve overall quality of life?&#xD;
  &#xD;
          -  Does the program improve self-efficacy - an individual's belief in their ability to&#xD;
             complete tasks to achieve their goals?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Fill out an online survey asking questions about their personal and health information,&#xD;
             as well as their mental health before the program&#xD;
  &#xD;
          -  Complete the online mental health program&#xD;
  &#xD;
          -  Fill out an online survey asking questions about their mental health after completing&#xD;
             the program, and 1-month and 3-months following completing the program&#xD;
  &#xD;
        Participants be compared against another group of children with CF and their healthy siblings&#xD;
        who are on a waitlist and receiving usual CF treatment. Researchers will compare participants&#xD;
        scores before starting the program with their scores immediately following completing the&#xD;
        program, 1-month, and 3-month after completing the program. Researchers hope to develop a&#xD;
        program that improves mental health, quality of life, self-efficacy, and knowledge about CF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        BACKGROUND: Children with cystic fibrosis (CF) and family members have been shown to&#xD;
        experience elevated psychological symptoms, such as depression and anxiety. Over the past&#xD;
        decade, significant advances have been made in the care of people living with CF, including&#xD;
        major steps toward assessing and promoting emotional wellness. Despite these advances, there&#xD;
        has been no specific mental health program designed for families with CF in Canada until&#xD;
        recently. To address the limitations of traditionally delivered mental health programs and&#xD;
        lack of developed Internet-delivered mental health programs for children with CF and their&#xD;
        siblings, the investigators created the self-guided Internet-delivered Cystic Fibrosis Mental&#xD;
        Health Prevention, Wellness, and Resource (iCF-PWR) program for children with CF and their&#xD;
        child siblings. The program was designed with a stepped-care model in mind, whereby all&#xD;
        children with CF and their child siblings could access and benefit from this preventative&#xD;
        program (i.e., least resource intensive intervention). If a child was in need of more&#xD;
        intensive services prior to or following iCF-PWR completion, then services could be accessed&#xD;
        through regular avenues (i.e., CF team, local outpatient/inpatient public mental health&#xD;
        services, or private practice). The self-guided iCF-PWR program was informed by those with&#xD;
        lived experiences with CF, the empirical literature [i.e., CF, mental health disorders in&#xD;
        childhood and adolescence with chronic illnesses, universal mental health prevention in&#xD;
        children and adolescence, stepped care, and team expertise. Individual contributions from&#xD;
        specific children with CF and child siblings directed the development of individual program&#xD;
        avatars and provided the personal stories and experiences embedded in the program modules.&#xD;
        Preliminary evidence suggests that the program is deemed acceptable. However, to date the&#xD;
        efficacy of the iCF-PWR is unknown.&#xD;
  &#xD;
        PARTICIPANTS: G*Power 3.1 was used to calculate the study sample size based upon on our&#xD;
        primary analyses (i.e., mixed model analysis of variance ANOVA]). Assuming 80% power, an&#xD;
        alpha of 0.05, and effect size of 0.25 (small to medium effect), a sample size of at least 24&#xD;
        participants in each group would be needed. The investigators aim to recruit 30 participants&#xD;
        per group to address attrition. 60 children (ages 8 to 12 years) with CF and 60 child&#xD;
        siblings (ages 8 to 12 years) will be recruited from the CF clinics and CF Chapters, CF&#xD;
        advocacy groups, advocacy groups for pediatric chronic illness across Canada in a 1-year&#xD;
        prospective study. Participants will be randomly assigned to either the iCF-PWR group or the&#xD;
        standard care group. The investigators will seek to have equal representation of gender&#xD;
        across both groups. Following the proposed maximum program completion time-frame (i.e., 6&#xD;
        weeks) and follow-up time period (i.e., 3 months), those in the standard care groups will be&#xD;
        provided access to iCF-PWR.&#xD;
  &#xD;
        HYPOTHESES:&#xD;
  &#xD;
          1. The iCF-PWR group will have significant reductions in self-reported anxiety symptoms&#xD;
             from pre- to post-program and at follow-up time points compared to the standard care&#xD;
             group.&#xD;
  &#xD;
          2. The iCF-PWR group will have significant reductions in self-reported depressive symptoms&#xD;
             from pre- to post-program and at follow-up time points compared to the standard care&#xD;
             group.&#xD;
  &#xD;
          3. The iCF-PWR group will have significant reductions in self-reported health anxiety from&#xD;
             pre- to post-program and at follow-up time points compared to the standard care group.&#xD;
  &#xD;
          4. The iCF-PWR group will have significant improvements in self-reported quality of life&#xD;
             from pre- to post-program and at follow-up time points compared to the standard care&#xD;
             group.&#xD;
  &#xD;
          5. The iCF-PWR group will have significant improvements in self-reported self-efficacy from&#xD;
             pre- to post-program and at follow-up time points compared to the standard care group.&#xD;
  &#xD;
        METHODS/PROCEDURES: Parent/guardian will be provided an overview of procedure in initial&#xD;
        email. Via Qualtrics (i.e., online survey platform) (1) parent/guardian will be asked to&#xD;
        complete consent form/facilitate the endorsement of assent form with child and complete and&#xD;
        complete a short personal/health demographics questionnaire about themselves and their child,&#xD;
        and (2) their child will be asked to complete a series of self-report questionnaires&#xD;
        assessing anxiety, depression, health anxiety, quality of life, self-efficacy, and disease&#xD;
        knowledge (pre-program measurement). The parent caregiver will help facilitate the child's&#xD;
        completion of questionnaires. Parent will be asked to complete measures of parent-rated child&#xD;
        anxiety and depression. This will take 5 minutes. Via email, child and parent/guardian will&#xD;
        be provided a link to complete these measures once the program is completed (post-program&#xD;
        measurement) and at two follow-up time points (1 month and 3 months post-program). Measure of&#xD;
        satisfaction will be completed by child at post-program as well. Measures will take&#xD;
        approximately 30 to 40 minutes to complete at each time-point. Similar time-points for&#xD;
        measure completion will be used for both study groups (i.e., iCF-PWR and standard care&#xD;
        groups). However, the satisfaction questionnaire will not be completed by standard care&#xD;
        group.&#xD;
  &#xD;
        Parents are encouraged to review the program along with their child and then children are&#xD;
        encouraged to complete the program at least 1 additional time, with an overall program&#xD;
        completion ranging from 3 to 6 weeks. Children can review the program as many times as they&#xD;
        would like. Once enrolled, parent caregiver will be provided with a username/password.&#xD;
        Parents/participants will be instructed to keep their username/password private. They will&#xD;
        also be encouraged to access the program in a private area, preferably in their own homes. A&#xD;
        contact e-mail will be given for technical support and instructions on how to operate the&#xD;
        site. All contact with the parents/participants will be via e-mail during program, although a&#xD;
        phone number will also be provided. Inquiries via email and telephone will be fielded by&#xD;
        study coordinator. A reminder e-mail will be sent to parents if child has not logged onto the&#xD;
        program at least 1x/week.&#xD;
  &#xD;
        ANALYSES: Statistical analyses will be performed using IBM SPSS Statistics-Version 26.&#xD;
        Demographic data will be summarized as means and standard deviations for continuous data and&#xD;
        frequencies for categorical data. Preliminary analyses will explore the potential impact of&#xD;
        demographic variables (e.g., age, gender) on primary and secondary outcome variables. If&#xD;
        demographic variables have a statistically significant impact on outcome measures, those&#xD;
        variables will be included as covariate(s) in primary and secondary analyses. An&#xD;
        intention-to-treat (ITT) design will be employed for all primary and secondary analyses.&#xD;
        Primary analyses will be three 2 (group: iCF-PWR vs standard care) x 4 (time of assessment:&#xD;
        pre-program vs. post-program vs. 1 month follow-up vs. 3 months follow-up) multi-level&#xD;
        modeling (equivalent to mixed- model ANOVAs) to examine the effect of the intervention on the&#xD;
        primary outcome measures (i.e., anxiety, depression, health anxiety). Secondary analyses will&#xD;
        be two 2 (group: iCF-PWR vs standard care) x 4 (time of assessment: pre-program vs&#xD;
        post-program vs 1 month follow-up vs 3 months follow-up) multilevel modeling to examine the&#xD;
        effect of the intervention on the secondary outcome measures (i.e., quality of life,&#xD;
        self-efficacy).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants will be randomly assigned to either the iCF-PWR group or the standard care group. The investigators will follow CONSORT guidelines for non-pharmacological trials with 1:1 random assignment to iCF-PWR or standard care. As such, 30 children with CF/30 child siblings will be randomly assigned to the iCF-PWR group and 30 children with CF/30 child siblings will be randomly assigned to the standard care group.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at Week 3-6</measure>
      <time_frame>Baseline and Week 3-6 (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 State-Trait Anxiety Inventory for Children (STAI-C) at 1 Month</measure>
      <time_frame>Baseline and 1-month follow up</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 State-Trait Anxiety Inventory for Children (STAI-C) at 3 Months</measure>
      <time_frame>Baseline and 3-months follow up</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) at Week 3-6</measure>
      <time_frame>Baseline and Week 3-6 (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 Children's Depression Inventory-2 (CDI-2) at 1 month</measure>
      <time_frame>Baseline and 1-month follow up</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 Children's Depression Inventory-2 (CDI-2) at 3 months</measure>
      <time_frame>Baseline and 3-months follow up</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) at Week 3-6</measure>
      <time_frame>Baseline and Week 3-6 (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 Illness Attitudes Scale (CIAS) at 1 month</measure>
      <time_frame>Baseline and 1-month follow up</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 Illness Attitudes Scale (CIAS) at 3 months</measure>
      <time_frame>Baseline and 3-months follow up</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 Pediatric Quality of Life Inventory (PedsQL-4.0) at Week 3-6</measure>
      <time_frame>Baseline and Week 3-6 (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 Pediatric Quality of Life Inventory (PedsQL-4.0) at 1 month</measure>
      <time_frame>Baseline and 1-month follow up</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 Pediatric Quality of Life Inventory (PedsQL-4.0) at 3 months</measure>
      <time_frame>Baseline and 3-months follow up</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 Self-Efficacy Questionnaire for Children (SEQ-2) at Week 3-6</measure>
      <time_frame>Baseline and Week 3-6 (post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 1 Month</measure>
      <time_frame>Baseline and 1-month follow up</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 3 Months</measure>
      <time_frame>Baseline and 3-months follow up</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in the Disease Knowledge Questionnaire at Week 3-6</measure>
      <time_frame>Baseline and Week 3-6 (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>
    <primary_outcome>
      <measure>Change from Baseline in the Disease Knowledge Questionnaire at 1 Month</measure>
      <time_frame>Baseline and 1-month follow up</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>
    <primary_outcome>
      <measure>Change from Baseline in the Disease Knowledge Questionnaire at 3 Months</measure>
      <time_frame>Baseline and 3-months follow up</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>
    <primary_outcome>
      <measure>Participants Qualitative Perception of Program Satisfaction at Week 3-6</measure>
      <time_frame>Week 3-6 (post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at Week 3-6</measure>
      <time_frame>Baseline and Week 3-6 (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 Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 1 Month</measure>
      <time_frame>Baseline and 1-month follow up</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 Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 3 Months</measure>
      <time_frame>Baseline and 3-months follow up</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) at Week 3-6</measure>
      <time_frame>Baseline and Week 3-6 (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>
    <secondary_outcome>
      <measure>Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 1 Month</measure>
      <time_frame>Baseline and 1-month follow up</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>
    <secondary_outcome>
      <measure>Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 3 Months</measure>
      <time_frame>Baseline and 3-months follow up</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>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Cystic Fibrosis in Children</condition>
    <condition>Siblings</condition>
    <condition>Mental Health</condition>
    <condition>Internet-based Intervention</condition>
    <arm_group>
      <arm_group_label>iCF-PWR Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</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. 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.</description>
      <arm_group_label>iCF-PWR Program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  between the ages of 8 and 12&#xD;
  &#xD;
            -  have a CF diagnosis or are a sibling of a child with CF&#xD;
  &#xD;
            -  can speak and read English. The research team does not have competence in other&#xD;
               languages, further our program is delivered in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  have a severe cognitive impairment or a major comorbid medical or psychiatric illness,&#xD;
               as this may impede their ability to fully participate in the program and evaluation&#xD;
               process&#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>Principal Investigator</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>
    <overall_contact_backup>
      <last_name>Dainelle M Caissie, M.Sc.</last_name>
      <email>danielle.caissie@uregina.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>BC Children's Hospital</name>
        <address>
          <city>Vancouver</city>
          <state>British Columbia</state>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Mark Chilvers, MRCPCH, MD</last_name>
        <phone>604-875-2345</phone>
        <phone_ext>4930</phone_ext>
        <email>MChilvers@cw.bc.ca</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Saskatchewan Health Authority</name>
        <address>
          <city>Regina</city>
          <state>Saskatchewan</state>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Julian Tam, MD</last_name>
        <phone>(306) 844-1009</phone>
        <email>julian.tam@saskhealthauthority.ca</email>
      </contact>
      <investigator>
        <last_name>Niki Asiff, RN</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>25246663</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>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.</citation>
      <PMID>24843053</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>27140670</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>27662107</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>24941199</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>21088072</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>21454321</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>17826170</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>16836477</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
    </reference>
    <reference>
      <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.</citation>
    </reference>
    <reference>
      <citation>Spielberger CD, Edwards CD, Montuori J, et al. State-Trait Anxiety Inventory for Children. Palo Alto, CA: Consulting Psychologist Press;1973.</citation>
    </reference>
    <reference>
      <citation>Kovacs M. Children's depression inventory-2. New York: Multi-Health System. 2011.</citation>
    </reference>
    <reference>
      <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.</citation>
      <PMID>16291551</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>11468499</PMID>
    </reference>
    <reference>
      <citation>Muris P. A brief questionnaire for measuring self-efficacy in youths. J Psychopathol Behav Assess 2001;23:145-49.</citation>
    </reference>
    <reference>
      <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.</citation>
      <PMID>31127422</PMID>
    </reference>
    <reference>
      <citation>Miles M, Huberman M. An Expanded Source Book: Qualitative Data Analysis. California: Sage Publications. 1994.</citation>
    </reference>
    <reference>
      <citation>Morse J, Field P. Qualitative research methods for health professionals. California: Sage Publications. 2005.</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cystic fibrosis</keyword>
    <keyword>child</keyword>
    <keyword>adolescent</keyword>
    <keyword>siblings</keyword>
    <keyword>mental health</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/NCT06020274
  org study id: 2022-166
  nct id: NCT06020274
  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 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.
  BACKGROUND: Children with cystic fibrosis (CF) and family members have been shown to
        experience elevated psychological symptoms, such as depression and anxiety. Over the past
        decade, significant advances have been made in the care of people living with CF, including
        major steps toward assessing and promoting emotional wellness. Despite these advances, there
        has been no specific mental health program designed for families with CF in Canada until
        recently. To address the limitations of traditionally delivered mental health programs and
        lack of developed Internet-delivered mental health programs for children with CF and their
        siblings, the investigators created the self-guided Internet-delivered Cystic Fibrosis Mental
        Health Prevention, Wellness, and Resource (iCF-PWR) program for children with CF and their
        child siblings. The program was designed with a stepped-care model in mind, whereby all
        children with CF and their child siblings could access and benefit from this preventative
        program (i.e., least resource intensive intervention). If a child was in need of more
        intensive services prior to or following iCF-PWR completion, then services could be accessed
        through regular avenues (i.e., CF team, local outpatient/inpatient public mental health
        services, or private practice). The self-guided iCF-PWR program was informed by those with
        lived experiences with CF, the empirical literature [i.e., CF, mental health disorders in
        childhood and adolescence with chronic illnesses, universal mental health prevention in
        children and adolescence, stepped care, and team expertise. Individual contributions from
        specific children with CF and child siblings directed the development of individual program
        avatars and provided the personal stories and experiences embedded in the program modules.
        Preliminary evidence suggests that the program is deemed acceptable. However, to date the
        efficacy of the iCF-PWR is unknown.
  
        PARTICIPANTS: G*Power 3.1 was used to calculate the study sample size based upon on our
        primary analyses (i.e., mixed model analysis of variance ANOVA]). Assuming 80% power, an
        alpha of 0.05, and effect size of 0.25 (small to medium effect), a sample size of at least 24
        participants in each group would be needed. The investigators aim to recruit 30 participants
        per group to address attrition. 60 children (ages 8 to 12 years) with CF and 60 child
        siblings (ages 8 to 12 years) will be recruited from the CF clinics and CF Chapters, CF
        advocacy groups, advocacy groups for pediatric chronic illness across Canada in a 1-year
        prospective study. Participants will be randomly assigned to either the iCF-PWR group or the
        standard care group. The investigators will seek to have equal representation of gender
        across both groups. Following the proposed maximum program completion time-frame (i.e., 6
        weeks) and follow-up time period (i.e., 3 months), those in the standard care groups will be
        provided access to iCF-PWR.
  
        HYPOTHESES:
  
          1. The iCF-PWR group will have significant reductions in self-reported anxiety symptoms
             from pre- to post-program and at follow-up time points compared to the standard care
             group.
  
          2. The iCF-PWR group will have significant reductions in self-reported depressive symptoms
             from pre- to post-program and at follow-up time points compared to the standard care
             group.
  
          3. The iCF-PWR group will have significant reductions in self-reported health anxiety from
             pre- to post-program and at follow-up time points compared to the standard care group.
  
          4. The iCF-PWR group will have significant improvements in self-reported quality of life
             from pre- to post-program and at follow-up time points compared to the standard care
             group.
  
          5. The iCF-PWR group will have significant improvements in self-reported self-efficacy from
             pre- to post-program and at follow-up time points compared to the standard care group.
  
        METHODS/PROCEDURES: Parent/guardian will be provided an overview of procedure in initial
        email. Via Qualtrics (i.e., online survey platform) (1) parent/guardian will be asked to
        complete consent form/facilitate the endorsement of assent form with child and complete and
        complete a short personal/health demographics questionnaire about themselves and their child,
        and (2) their child will be asked to complete a series of self-report questionnaires
        assessing anxiety, depression, health anxiety, quality of life, self-efficacy, and disease
        knowledge (pre-program measurement). The parent caregiver will help facilitate the child's
        completion of questionnaires. Parent will be asked to complete measures of parent-rated child
        anxiety and depression. This will take 5 minutes. Via email, child and parent/guardian will
        be provided a link to complete these measures once the program is completed (post-program
        measurement) and at two follow-up time points (1 month and 3 months post-program). Measure of
        satisfaction will be completed by child at post-program as well. Measures will take
        approximately 30 to 40 minutes to complete at each time-point. Similar time-points for
        measure completion will be used for both study groups (i.e., iCF-PWR and standard care
        groups). However, the satisfaction questionnaire will not be completed by standard care
        group.
  
        Parents are encouraged to review the program along with their child and then children are
        encouraged to complete the program at least 1 additional time, with an overall program
        completion ranging from 3 to 6 weeks. Children can review the program as many times as they
        would like. Once enrolled, parent caregiver will be provided with a username/password.
        Parents/participants will be instructed to keep their username/password private. They will
        also be encouraged to access the program in a private area, preferably in their own homes. A
        contact e-mail will be given for technical support and instructions on how to operate the
        site. All contact with the parents/participants will be via e-mail during program, although a
        phone number will also be provided. Inquiries via email and telephone will be fielded by
        study coordinator. A reminder e-mail will be sent to parents if child has not logged onto the
        program at least 1x/week.
  
        ANALYSES: Statistical analyses will be performed using IBM SPSS Statistics-Version 26.
        Demographic data will be summarized as means and standard deviations for continuous data and
        frequencies for categorical data. Preliminary analyses will explore the potential impact of
        demographic variables (e.g., age, gender) on primary and secondary outcome variables. If
        demographic variables have a statistically significant impact on outcome measures, those
        variables will be included as covariate(s) in primary and secondary analyses. An
        intention-to-treat (ITT) design will be employed for all primary and secondary analyses.
        Primary analyses will be three 2 (group: iCF-PWR vs standard care) x 4 (time of assessment:
        pre-program vs. post-program vs. 1 month follow-up vs. 3 months follow-up) multi-level
        modeling (equivalent to mixed- model ANOVAs) to examine the effect of the intervention on the
        primary outcome measures (i.e., anxiety, depression, health anxiety). Secondary analyses will
        be two 2 (group: iCF-PWR vs standard care) x 4 (time of assessment: pre-program vs
        post-program vs 1 month follow-up vs 3 months follow-up) multilevel modeling to examine the
        effect of the intervention on the secondary outcome measures (i.e., quality of life,
        self-efficacy).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomly assigned to either the iCF-PWR group or the standard care group. The investigators will follow CONSORT guidelines for non-pharmacological trials with 1:1 random assignment to iCF-PWR or standard care. As such, 30 children with CF/30 child siblings will be randomly assigned to the iCF-PWR group and 30 children with CF/30 child siblings will be randomly assigned to the standard care group.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at Week 3-6
  time frame: Baseline and Week 3-6 (post-intervention)
  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 State-Trait Anxiety Inventory for Children (STAI-C) at 1 Month
  time frame: Baseline and 1-month follow up
  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 State-Trait Anxiety Inventory for Children (STAI-C) at 3 Months
  time frame: Baseline and 3-months follow up
  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) at Week 3-6
  time frame: Baseline and Week 3-6 (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 Children's Depression Inventory-2 (CDI-2) at 1 month
  time frame: Baseline and 1-month follow up
  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 Children's Depression Inventory-2 (CDI-2) at 3 months
  time frame: Baseline and 3-months follow up
  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) at Week 3-6
  time frame: Baseline and Week 3-6 (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 Illness Attitudes Scale (CIAS) at 1 month
  time frame: Baseline and 1-month follow up
  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 Illness Attitudes Scale (CIAS) at 3 months
  time frame: Baseline and 3-months follow up
  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 Pediatric Quality of Life Inventory (PedsQL-4.0) at Week 3-6
  time frame: Baseline and Week 3-6 (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 Pediatric Quality of Life Inventory (PedsQL-4.0) at 1 month
  time frame: Baseline and 1-month follow up
  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 Pediatric Quality of Life Inventory (PedsQL-4.0) at 3 months
  time frame: Baseline and 3-months follow up
  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 Self-Efficacy Questionnaire for Children (SEQ-2) at Week 3-6
  time frame: Baseline and Week 3-6 (post-intervention)
  description: 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.
  measure: Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 1 Month
  time frame: Baseline and 1-month follow up
  description: 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.
  measure: Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 3 Months
  time frame: Baseline and 3-months follow up
  description: 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.
  measure: Change from Baseline in the Disease Knowledge Questionnaire at Week 3-6
  time frame: Baseline and Week 3-6 (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 Disease Knowledge Questionnaire at 1 Month
  time frame: Baseline and 1-month follow up
  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 Disease Knowledge Questionnaire at 3 Months
  time frame: Baseline and 3-months follow up
  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: Participants Qualitative Perception of Program Satisfaction at Week 3-6
  time frame: Week 3-6 (post-intervention)
  description: 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.
  measure: Change from Baseline in the Children's Depression Inventory-2 - Parent Report (CDI-2 P) at Week 3-6
  time frame: Baseline and Week 3-6 (post-intervention)
  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 Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 1 Month
  time frame: Baseline and 1-month follow up
  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 Children's Depression Inventory-2 - Parent Report (CDI-2 P) at 3 Months
  time frame: Baseline and 3-months follow up
  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) at Week 3-6
  time frame: Baseline and Week 3-6 (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.
  measure: Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 1 Month
  time frame: Baseline and 1-month follow up
  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.
  measure: Change from Baseline in the State-Trait Anxiety Inventory - Parent Version (STAI-P) at 3 Months
  time frame: Baseline and 3-months follow up
  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 Program
  arm group type: Experimental
  description: 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.
  arm group label: Standard Care
  arm group type: No Intervention
  description: 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.
  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. 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.
  arm group label: iCF-PWR Program
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Kristi D Wright, Ph.D.
  role: Principal Investigator
  affiliation: University of Regina
  last name: Shelby M Shivak, M.A.
  phone: 3065506874
  email: shivak3s@uregina.ca
  last name: Dainelle M Caissie, M.Sc.
  email: danielle.caissie@uregina.ca
  facility: 
  contact: 
  facility: 
  contact: 
  investigator: 
  country: Canada
  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.
  PMID: 25246663
  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: 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
  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.
  PMID: 27140670
  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.
  PMID: 27662107
  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.
  PMID: 24941199
  citation: 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
  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.
  PMID: 21454321
  citation: 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
  citation: 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
  citation: 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.
  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.
  citation: Spielberger CD, Edwards CD, Montuori J, et al. State-Trait Anxiety Inventory for Children. Palo Alto, CA: Consulting Psychologist Press;1973.
  citation: Kovacs M. Children's depression inventory-2. New York: Multi-Health System. 2011.
  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.
  PMID: 16291551
  citation: 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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  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.
  PMID: 31127422
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  responsible party type: Sponsor
  mesh term: Cystic Fibrosis
  mesh term: Fibrosis
  sharing ipd: No