Narcolepsy Type 1NCT06251063
Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence
A study testing Web-based psychoeducational resource in people with Narcolepsy Type 1 and Narcolepsy Type 2, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- What is being tested?
- Web-based psychoeducational resource
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Being tested
- Web-based psychoeducational resource
- Keywords
- Narcolepsy Type 1, Narcolepsy Type 2, Central Disorders of Hypersomnolence, Idiopathic Hypersomnia, Social Relationships, Adolescents
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based psychoeducational resourceBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Web-based psychoeducational resource |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Acceptability (Enrollment)
Proportion of eligible families who express interest in the study choosing to enroll.
Measured: 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).
Measured: 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?".
Measured: 5 weeks
Feasibility (Website Access)
Proportion of participants that access the website at least once during the study period.
Measured: 5 weeks
Feasibility (Assessment Completion)
Proportion of participants who complete the Post-Intervention Assessment.
Measured: 5 weeks
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: 0 weeks and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Apr 2024
- Primary completion10 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Principal investigator, Eric Zhou, PhD, Boston Children's Hospital
- Investigators
- Eric Zhou, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251063
- Sponsor's protocol ID
- IRB-P00047080
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36468655
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence
- ClinicalTrials.gov ID
- NCT06251063
- Acronym / sponsor ID
- IRB-P00047080
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based psychoeducational Resource | Experimental | Behavioral: Web-based psychoeducational resourceEligible 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based psychoeducational resourceThe 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 | Behavioural | Web-based psychoeducational Resource |
Primary outcome
Usability
Time frame: 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)
Time frame: 5 weeks
Proportion of eligible families who express interest in the study choosing to enroll.
Acceptability (Satisfaction)
Time frame: 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)
Time frame: 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)
Time frame: 5 weeks
Proportion of participants that access the website at least once during the study period.
Feasibility (Assessment Completion)
Time frame: 5 weeks
Proportion of participants who complete the Post-Intervention Assessment.
3 secondary outcomes
Relationship Quality
Time frame: 0 weeks and 5 weeks
Social Problems (Loneliness)
Time frame: 0 weeks and 5 weeks
Social Problems (Social Relationships)
Time frame: 0 weeks and 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 36468655Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Zhou, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based psychoeducational resource in people with Narcolepsy Type 1 and Narcolepsy Type 2, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: 5 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06251063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.