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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Hypersomnia; Narcolepsy Type 1; Narcolepsy Type 2
• Intervention / Treatment: Behavioral: Web-based psychoeducational resource

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grace Y Wang; Phone Number: 617-919-6212; Email: grace.wang@childrens.harvard.edu
• Study Contact Backup: Name: Eric Zhou, PhD

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Eric Zhou, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: American Academy of Sleep Medicine
• Investigators: Principal Investigator: Eric Zhou, PhD, Boston Children's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Idiopathic Hypersomnia; Narcolepsy Type 1; Narcolepsy Type 2; Central Disorders of Hypersomnolence; Social Relationships
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy; Idiopathic Hypersomnia
• Other Study ID Numbers: IRB-P00047080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No