Improving Social Relationships for Adolescents with Central Disorders of Hypersomnolence

Boston Children's Hospital

Status: Enrolling

Conditions: Narcolepsy Type 2; Idiopathic Hypersomnia; Narcolepsy Type 1

Treatments: Behavioral: Web-based psychoeducational resource

Study type: Interventional

Funder types: Other

Identifiers

NCT06251063

IRB-P00047080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Web-based psychoeducational Resource

Experimental group

Description:

Eligible families will be provided with website access instructions. Parents and children will be instructed to review the materials separately. The intervention will provide each person with individualized action items to be discussed as a family. It is anticipated that reviewing all of the psychoeducational materials will take the parent/child approximately one hour, resulting in a total intervention burden of two hours for the family. Participants will be encouraged to return to the website as often as needed to review content. For the purposes of this project, they will be instructed to review all intervention materials within one month of receiving the website access instructions.

Treatment:

Behavioral: Web-based psychoeducational resource