Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251063
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-01-23
Brief Title:
Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 websites 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 adolescents social relationships and social health before and after reviewing the website through online surveys
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 adolescents social relationships and social health before and after reviewing the website through online surveys
Detailed Description:
The American Academy of Sleep Medicines 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 NT1NT2 and idiopathic hypersomnia IH With one peak for symptom onset in adolescence a critical period in a childs social development children with NT1NT2IH 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 adolescents 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 NT1NT2IH with the potential to be widely disseminated
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 NT1NT2IH with the potential to be widely disseminated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None