Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence

NCT06251063 | Completed

• 1 other identifier: IRB-P00047080
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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

• Acceptability (Enrollment)

  Proportion of eligible families who express interest in the study choosing to enroll.

  5 weeks

• 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

• 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

• Feasibility (Website Access)

  Proportion of participants that access the website at least once during the study period.

  5 weeks

• Feasibility (Assessment Completion)

  Proportion of participants who complete the Post-Intervention Assessment.

  5 weeks

Secondary Outcomes (3)

• Relationship Quality

  0 weeks and 5 weeks

• Social Problems (Loneliness)

  0 weeks and 5 weeks

• Social Problems (Social Relationships)

  0 weeks and 5 weeks

Study Arms (1)

Web-based psychoeducational Resource

EXPERIMENTAL

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.

Behavioral: Web-based psychoeducational resource

Interventions

Web-based psychoeducational resource BEHAVIORAL

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

Web-based psychoeducational Resource

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 36468655 BACKGROUND

MeSH Terms

Conditions

Idiopathic Hypersomnia

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Eric Zhou, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 9, 2024
• Study Start: April 1, 2024
• Primary Completion: May 10, 2025
• Study Completion: May 10, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)