Clinical trial NCT06251063: Improving Social Relationships for Adolescents with Central Disorders of Hypersomnolence
Official title: Improving Social Relationships for Adolescents with Central Disorders of Hypersomnolence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Narcolepsy Type 1
Narcolepsy Type 2
Idiopathic Hypersomnia
Keywords: Narcolepsy Type 1
Narcolepsy Type 2
Central Disorders of Hypersomnolence
Idiopathic Hypersomnia
Social Relationships
Adolescents
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2024-02-09
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The American Academy of Sleep Medicine's clinical practice guideline task force concluded that "reliance on medications alone to treat CNS hypersomnia conditions is likely insufficient." Our stakeholder data demonstrated that this issue is a significant challenge in the domain of social relationship health for children with narcolepsy type 1 and 2 (NT1/NT2) and idiopathic hypersomnia (IH). With one peak for symptom onset in adolescence, a critical period in a child's social development, children with NT1/NT2/IH and their families report significant social sequelae of the disorder and its treatment that have lifelong implications. To address this important, yet consistently overlooked real-life concern for adolescents with CDH, the investigators intend to assess an online psychoeducational website that the investigators designed to provide families with the knowledge and resources to improve the adolescent's social relationship health.

A total of 45 families will participate in a single-arm usability, feasibility, and acceptability trial. Eligible families will be provided with instructions on how to access the website. Participants will be encouraged to return to the website as often as needed to review content. For the purposes of this study, participants will be instructed to review all intervention materials within one month of receiving website access. The participants will then complete feedback questionnaires on the secure online platform REDCap. This study will inform a future randomized controlled trial testing the efficacy of the investigators' intervention. The investigators' stakeholder informed program will be the first of its kind for children with NT1/NT2/IH, with the potential to be widely disseminated.

Eligibility criteria: 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

Primary outcomes:
measure: Usability
timeFrame: 5 weeks
measure: Acceptability (Enrollment)
timeFrame: 5 weeks
measure: Acceptability (Satisfaction)
timeFrame: 5 weeks
measure: Acceptability (Recommend Website)
timeFrame: 5 weeks
measure: Feasibility (Website Access)
timeFrame: 5 weeks
measure: Feasibility (Assessment Completion)
timeFrame: 5 weeks
Secondary outcomes:
measure: Relationship Quality
timeFrame: 0 weeks and 5 weeks
measure: Social Problems (Loneliness)
timeFrame: 0 weeks and 5 weeks
measure: Social Problems (Social Relationships)
timeFrame: 0 weeks and 5 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Eric Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.