Improving Social Relationships for Adolescents with Central Disorders of Hypersomnolence
NCT ID: NCT06251063
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2024-04-01
2025-05-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Web-based psychoeducational Resource
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.
Web-based psychoeducational resource
The website will incorporate animations/illustrations to enhance comprehension, patient stories, and video-based expert explanations.
The materials will address the following content areas:
* Provide families with data demonstrating how prevalent social relationship struggles are for children with CDH.
* Describe specific social challenges that commonly affect children with CDH.
* Explain the impact that medications typically prescribed for CDH may have on social relationship health.
* Help families advocate for their child's social needs at school.
* Support children and their families in decision-making about appropriate disclosure with peers at school and in extracurricular settings.
* Offer strategies to support families in raising the issue of social relationship health with the child's sleep physician.
* Provide a list of programming which offers children both structured and unstructured opportunities for social engagement
Interventions
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Web-based psychoeducational resource
The website will incorporate animations/illustrations to enhance comprehension, patient stories, and video-based expert explanations.
The materials will address the following content areas:
* Provide families with data demonstrating how prevalent social relationship struggles are for children with CDH.
* Describe specific social challenges that commonly affect children with CDH.
* Explain the impact that medications typically prescribed for CDH may have on social relationship health.
* Help families advocate for their child's social needs at school.
* Support children and their families in decision-making about appropriate disclosure with peers at school and in extracurricular settings.
* Offer strategies to support families in raising the issue of social relationship health with the child's sleep physician.
* Provide a list of programming which offers children both structured and unstructured opportunities for social engagement
Eligibility Criteria
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Inclusion Criteria
* 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
10 Years
17 Years
ALL
No
Sponsors
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American Academy of Sleep Medicine
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Eric Zhou, PhD
Assistant Professor
Principal Investigators
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Eric Zhou, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Eric Zhou, PhD
Role: CONTACT
Facility Contacts
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Eric Zhou, PhD
Role: primary
References
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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.
Other Identifiers
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IRB-P00047080
Identifier Type: -
Identifier Source: org_study_id
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