Idiopathic Hypersomnia Clinical Trial
Official title:
Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence
The goal of this study is to test a web-based psychoeducational resource for adolescents with central disorders of hypersomnolence and their families. The investigators hope to assess the website's usability, acceptability, and feasibility, as well as its potential effect on social relationship health. Participants will be asked to review the content of the psychoeducational websites. The participants will then provide feedback on the website, as well as the adolescent's social relationships and social health before and after reviewing the website through online surveys.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | May 1, 2025 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility | Inclusion Criteria: - Adolescent from 10-17 years of age and parent of the adolescent - Adolescent has physician-diagnosed narcolepsy type 1 or type 2, or idiopathic hypersomnia - English fluency - Interest in learning more about how to improve social health for adolescents with a CDH |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | American Academy of Sleep Medicine |
United States,
Zhou ES, Revette A, Heckler GK, Worhach J, Maski K, Owens JA. Building a deeper understanding of social relationship health in adolescents with narcolepsy disorder. J Clin Sleep Med. 2023 Mar 1;19(3):491-498. doi: 10.5664/jcsm.10372. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Usability | System Usability Scale. The minimum score is 10 and the maximum score is 50. Each question is measured on a scale from 1-5. A higher score indicates higher usability (better outcome). Completed by both the parent and child. | 5 weeks | |
Primary | Acceptability (Enrollment) | Proportion of eligible families who express interest in the study choosing to enroll. | 5 weeks | |
Primary | Acceptability (Satisfaction) | Satisfaction subscale of the Usability, Satisfaction, and Ease of use scale. Each question is measured on a scale from 1-7. The minimum score is 7 and the maximum score is 49. A higher score indicates higher website satisfaction (better outcome). | 5 weeks | |
Primary | Acceptability (Recommend Website) | Proportion of participants who respond positively to the Post-Intervention questionnaire item "Would you recommend this website to other families of children with NT1/NT2/IH?". | 5 weeks | |
Primary | Feasibility (Website Access) | Proportion of participants that access the website at least once during the study period. | 5 weeks | |
Primary | Feasibility (Assessment Completion) | Proportion of participants who complete the Post-Intervention Assessment. | 5 weeks | |
Secondary | Relationship Quality | Patient Reported Outcomes Measurement Information System Pediatric Peer Relationships Scale (PROMIS-PPRS). Each question is measured on a scale of 0-4. The minimum score is 0 and the maximum score is 32. A higher score means better peer relationships (better outcome). | 0 weeks and 5 weeks | |
Secondary | Social Problems (Loneliness) | UCLA Three-Item Loneliness Scale. Completed by patient and parent. Each question is measured on a scale of 1-3. The minimum score is 3 and the maximum score is 9. A higher score means more loneliness (worse outcome). | 0 weeks and 5 weeks | |
Secondary | Social Problems (Social Relationships) | NIH Toolbox Pediatric Social Relationship Scales. Using the Emotional Support, Friendship, and Perceived Rejection Items. Each question is measured on a scale of 1-5. The minimum score is 19 and the maximum score is 95. A higher score means better social relationships (better outcome). | 0 weeks and 5 weeks |
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