Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence

Not Applicable

Recruiting

• Conditions: Idiopathic Hypersomnia; Narcolepsy Type 2; Narcolepsy Type 1
• Interventions: Behavioral: Web-based psychoeducational resource

• Registration Number: NCT06251063
• Lead Sponsor: Boston Children's Hospital

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.

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-09
• Status Verified: 2024-04
• Study Start: 2024-04-01
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Web-based psychoeducational Resource	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.

Primary Outcome Measures

Name	Time	Method
Usability	5 weeks	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.
Acceptability (Enrollment)	5 weeks	Proportion of eligible families who express interest in the study choosing to enroll.
Acceptability (Satisfaction)	5 weeks	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).
Acceptability (Recommend Website)	5 weeks	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?".
Feasibility (Website Access)	5 weeks	Proportion of participants that access the website at least once during the study period.
Feasibility (Assessment Completion)	5 weeks	Proportion of participants who complete the Post-Intervention Assessment.

Secondary Outcome Measures

Name	Time	Method
Social Problems (Social Relationships)	0 weeks and 5 weeks	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).
Relationship Quality	0 weeks and 5 weeks	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).
Social Problems (Loneliness)	0 weeks and 5 weeks	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).

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States