Psychoeducational Resource for Sleeping Disorders

Overseen By Eric Zhou, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based psychoeducational resource designed to assist teenagers with sleep disorders such as narcolepsy or idiopathic hypersomnia. The goal is to evaluate the website's user-friendliness and effectiveness in improving social relationships. Families will review the content and share their thoughts on the website and any changes in social interactions. This trial suits English-speaking teens aged 10-17 who have received a diagnosis of these sleep disorders and seek to improve their social health. As an unphased trial, it offers participants a unique opportunity to contribute to developing innovative resources that could enhance social well-being for teens with sleep disorders.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on reviewing a website, so it's unlikely that medication changes are required.

What prior data suggests that this web-based psychoeducational resource is safe for adolescents with sleeping disorders?

Research shows that online educational tools are generally safe and easy to use. Studies have found that these tools can improve sleep and reduce issues like insomnia and daytime fatigue without causing harm. For example, one study found that digital sleep programs led to better sleep health.

Since this trial tests an online resource, it poses less risk than medication-based treatments. Participants primarily engage with educational content online, so the chance of side effects is very low. Overall, existing evidence suggests that these digital tools offer a safe way to manage sleep problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the web-based psychoeducational resource for sleeping disorders because it offers a unique, accessible approach that empowers families to manage sleep issues together. Unlike traditional treatments that might involve medication or in-person therapy, this resource provides individualized action items for both parents and children to discuss, fostering family collaboration. The online format allows participants to engage with the materials at their own pace, anytime and anywhere, making it a flexible option that can be revisited as needed. This method not only aims to improve sleep but also strengthens family communication around health topics.

What evidence suggests that this web-based psychoeducational resource is effective for sleeping disorders?

Research shows that online educational tools can help with sleep problems. Studies indicate that self-help programs using cognitive behavioral therapy for insomnia (CBT-I) lessen insomnia and improve sleep quality. Another study found that digital tools reduce the risk of long-term insomnia and boost mood. Self-guided online programs have also helped university students sleep better. This trial will evaluate a web-based psychoeducational resource, which might assist teenagers experiencing excessive sleepiness. ^{2 6 7 8 9}

Who Is on the Research Team?

Eric Zhou, PhD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for adolescents aged 10-19 with narcolepsy type 1 or type 2, or idiopathic hypersomnia, and their parents. Participants must speak English fluently and be interested in improving social health for those with central disorders of hypersomnolence.

Inclusion Criteria

I want to learn how to improve social health for teens with a CDH.

I am between 10-19 years old, or I am the parent of an adolescent in this age range.

I am a teenager diagnosed with narcolepsy or idiopathic hypersomnia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants review the psychoeducational website content and provide feedback

4 weeks

Online access as needed

Follow-up

Participants complete post-intervention assessments to evaluate usability, acceptability, and social relationship health

1 week

Online survey completion

What Are the Treatments Tested in This Trial?

Interventions

• Web-based psychoeducational resource

Trial Overview

The study is testing a web-based psychoeducational resource designed to help teenagers with excessive sleepiness disorders and their families. It aims to evaluate the website's user-friendliness, acceptance, practicality, and its impact on the teens' social relationships.

How Is the Trial Designed?

Group I: Web-based psychoeducational Resource Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

Published Research Related to This Trial

A quality improvement project involving 124 psychiatric patients showed that individualized safety plans created during inpatient treatment were well-tailored, scoring an average of 32.85 out of 44 on a customization rubric.

Postdischarge, 96.1% of patients retained their safety plans, and 36.8% reported using them, with 67.9% of those users finding the plans helpful, indicating that these plans can support recovery after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. Leonard, J., Chiappetta, L., Stark, S., et al.[2023]

A computer-delivered psycho-education program was well-received by patients in forensic psychiatry, with participants (n=10) finding it easy to use and enjoyable, which suggests good user engagement.

The study indicates that this CD-ROM approach is an effective method for educating patients about psychosis, particularly appealing to younger individuals who are more comfortable with technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based education for patients with psychosis. Walker, H.[2016]

A psychoeducational program called 'Sleep 101' significantly improved sleep hygiene knowledge and reduced negative beliefs about sleep among college students, as shown by a study involving sleep log recordings and workshops.

Participants in the Sleep 101 program experienced shorter sleep onset times compared to those in the control group, suggesting that such brief educational interventions can effectively promote healthier sleep practices in young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A "Sleep 101" Program for College Students Improves Sleep Hygiene Knowledge and Reduces Maladaptive Beliefs about Sleep. Kloss, JD., Nash, CO., Walsh, CM., et al.[2022]

A psycho-educational training course for sleep disorders, viewed by about 200,000 people, led to a significant decrease in sleep latency by 25 minutes and an increase in total sleep duration by nearly 40 minutes among participants.

Approximately 40% of participants who were using hypnotic drugs stopped their use after completing the course, indicating that this approach is not only effective but also cost-effective by reducing reliance on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of insomnia through mass media, the results of a televised behavioral training programme. Oosterhuis, A., Klip, EC.[2019]

The online multifamily psychoeducational therapy significantly reduced positive symptoms in individuals with schizophrenia, showing a large effect size (d=-.88) compared to those receiving usual care.

Support persons also benefited from the online intervention, with a significant increase in their knowledge about schizophrenia prognosis (d=1.94), highlighting the effectiveness of telehealth in enhancing understanding for both patients and their support networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based psychoeducational intervention for persons with schizophrenia and their supporters: one-year outcomes. Rotondi, AJ., Anderson, CM., Haas, GL., et al.[2022]

Incorporating healthy sleep education into pediatric practice is essential for improving children's overall health and well-being, as it addresses common sleep issues that can affect development.

The article identifies practical strategies and resources for pediatricians to implement effective sleep education programs, while also discussing potential barriers and how to overcome them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep health education in pediatric community settings: rationale and practical suggestions for incorporating healthy sleep education into pediatric practice. Gruber, R., Cassoff, J., Knäuper, B.[2022]

In an observational study of 763 patients undergoing an 8-week transdiagnostic internet-delivered cognitive behavior therapy (T-ICBT) course, 30.1% utilized a brief sleep resource designed to help with insomnia, particularly those with higher initial insomnia symptoms.

Despite patient satisfaction with the sleep resource, it did not lead to significant improvements in insomnia symptoms compared to those who did not use it, indicating a need for further research on its integration and effectiveness in T-ICBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the Utility of a Sleep Resource in Transdiagnostic Internet-Delivered Cognitive Behavior Therapy: An Observational Study. Peynenburg, V., Ababei, A., Wilhelms, A., et al.[2022]

Current evaluations of psychoeducational interventions using interactive digital multimedia often lack comprehensiveness, indicating a need for standardized evaluation models that cover all relevant aspects of development and efficacy.

The proposed comprehensive evaluation model integrates various evaluation domains, including intervention theory, design strategies, efficacy, and contextual issues, and is particularly illustrated through its application to electroencephalographic biofeedback for ADHD, providing a useful framework for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation model for psychoeducational interventions using interactive multimedia. Beale, IL.[2019]

Psychoeducation is underutilized in psychiatry, despite its potential benefits, while the use of therapeutic patient education programs has increased but still represents less than 4% of validated programs in France, indicating a need for greater implementation.

Therapeutic patient education has a legal framework and established guidelines, making it a valuable approach for improving patient engagement and treatment outcomes in psychiatric and addiction disorders, ultimately enhancing patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Education care in patients with psychiatric disorders in France: Psychoeducation or therapeutic patient education?] Lang, JP., Jurado, N., Herdt, C., et al.[2019]

Only 6% of clinical psychology programs offer formal courses on sleep, and only 31% provide training in treating sleep disorders, indicating a significant gap in education on this important topic.

39% of training directors expressed interest in implementing a standard curriculum on sleep if it were available, highlighting the demand for enhanced training in sleep education for future psychologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical psychology training in sleep and sleep disorders. Meltzer, LJ., Phillips, C., Mindell, JA.[2021]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

The Enhancing Quality Use of Medication Self-Reported Questionnaire (EQUIM-SRQ) was found to be applicable and interpretable in an Australian mental health outpatient population, despite a low response rate of only 18% from 160 distributed questionnaires.

The study suggests that the EQUIM-SRQ could be useful for future research and clinical practice, as it was acceptable to participants, with some needing assistance to complete it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Enhancing Quality Use of Medication Self-Reported Questionniare (EQUIM-SRQ) among mental health consumers: a pilot study. Ashoorian, D., Salter, S., Denton, T., et al.[2015]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

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