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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

The goal of the clinical trial is to test whether a mental health program that is delivered through the Internet works well for children and adolescents with cystic fibrosis (CF) and their healthy siblings. The main questions it aims to answer are:

* Does the program improve the mental health such as depression and anxiety symptoms?
* Does the program improve overall quality of life?
* Does the program improve self-efficacy - an individual's belief in their ability to complete tasks to achieve their goals?

Participants will:

* Fill out an online survey asking questions about their personal and health information, as well as their mental health before the program
* Complete the online mental health program
* Fill out an online survey asking questions about their mental health after completing the program, and 1-month and 3-months following completing the program

Participants be compared against another group of children with CF and their healthy siblings who are on a waitlist and receiving usual CF treatment. Researchers will compare participants scores before starting the program with their scores immediately following completing the program, 1-month, and 3-month after completing the program. Researchers hope to develop a program that improves mental health, quality of life, self-efficacy, and knowledge about CF.

Eligibility

Primary outcome measure(s)

• Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at Week 3-6 — Baseline and Week 3-6 (post-intervention)
  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.
• Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at 1 Month — Baseline and 1-month follow up
  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.
• Change from Baseline in the State-Trait Anxiety Inventory for Children (STAI-C) at 3 Months — Baseline and 3-months follow up
  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.
• Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at Week 3-6 — Baseline and Week 3-6 (post-intervention)
  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.
• Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at 1 month — Baseline and 1-month follow up
  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.
• Change from Baseline in the Children's Depression Inventory-2 (CDI-2) at 3 months — Baseline and 3-months follow up
  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.
• Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at Week 3-6 — Baseline and Week 3-6 (post-intervention)
  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.
• Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at 1 month — Baseline and 1-month follow up
  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.
• Change from Baseline in the Childhood Illness Attitudes Scale (CIAS) at 3 months — Baseline and 3-months follow up
  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.
• Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at Week 3-6 — Baseline and Week 3-6 (post-intervention)
  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.
• Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at 1 month — Baseline and 1-month follow up
  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.
• Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL-4.0) at 3 months — Baseline and 3-months follow up
  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.
• Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at Week 3-6 — Baseline and Week 3-6 (post-intervention)
  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.
• Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 1 Month — Baseline and 1-month follow up
  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.
• Change from Baseline in the Self-Efficacy Questionnaire for Children (SEQ-2) at 3 Months — Baseline and 3-months follow up
  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.
• Change from Baseline in the Disease Knowledge Questionnaire at Week 3-6 — Baseline and Week 3-6 (post-intervention)
  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.
• Change from Baseline in the Disease Knowledge Questionnaire at 1 Month — Baseline and 1-month follow up
  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.
• Change from Baseline in the Disease Knowledge Questionnaire at 3 Months — Baseline and 3-months follow up
  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.
• Participants Qualitative Perception of Program Satisfaction at Week 3-6 — Week 3-6 (post-intervention)
  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.

Trial sites (2)

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