Cognitive Behavioral Therapy for Insomnia in Youth
(NiteCAPP JR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a digital form of Cognitive Behavioral Therapy for Insomnia (CBT-I) specifically designed for school-aged children. The goal is to evaluate the effectiveness of this digital treatment and assess its ease of use and helpfulness for both children and parents. Children with insomnia who struggle with falling asleep, staying asleep, or waking up too early, affecting their daily activities, may be suitable candidates for this study. Participants will be randomly assigned to begin the therapy immediately or after a short delay. As an unphased trial, this study provides a unique opportunity for children to access innovative therapy that could enhance their sleep and daily life.
Will I have to stop taking my current medications?
If your child is taking stimulants, sleep medications, or melatonin, they can continue as long as they have been stable on them for at least 3 months. Other medications that alter sleep may require stopping before joining the trial.
What prior data suggests that this digital CBT-I is safe for school-aged children?
Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe for children and teenagers. Studies have found that CBT-I effectively helps young people with sleep problems, such as difficulty falling asleep and improving overall sleep quality. There are no major reports of negative effects in this age group.
CBT-I is a therapy that changes thoughts and behaviors related to sleep. It is non-invasive, involving no medication or physical procedures, making it a low-risk option for treating insomnia. The therapy focuses on teaching better sleep habits and addressing worries that might keep someone awake.
In previous studies, children and teenagers who tried CBT-I reported better sleep without major side effects. The therapy involves working on sleep schedules and reducing factors that might disrupt sleep, like excessive screen time before bed. This approach has been well-received, making it a promising option for young people with sleep issues.12345Why are researchers excited about this trial?
Researchers are excited about CBT-I for insomnia in youth because it offers a non-pharmacological approach tailored specifically for younger populations. Unlike standard treatments such as sleep medications or general sleep hygiene education, CBT-I uses a digital, interactive format that can engage children directly and effectively. This method not only aims to improve sleep patterns through cognitive and behavioral strategies but also empowers kids to better manage their insomnia long-term without relying on medication.
What evidence suggests that CBT-I might be an effective treatment for insomnia?
Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively helps children and teenagers with sleep problems. Studies have found that CBT-I enables young people to fall asleep faster and sleep longer. In this trial, some participants will receive immediate CBT-I through a 4-session digital intervention. One study found that using a CBT-I app not only improved sleep but also helped prevent depression in young people with insomnia. Offering CBT-I in schools is also considered a good way to help children with sleep issues. Overall, multiple studies support CBT-I as a promising method to improve sleep in young individuals.23678
Are You a Good Fit for This Trial?
This trial is for children aged 6-12 with insomnia, which includes trouble falling or staying asleep, and daytime issues caused by poor sleep. They must have had these problems for over 3 months. A parent or guardian who lives with them and can read English at a 5th-grade level must participate too. Both child and caregiver must be okay with being randomly placed in the study groups.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Immediate CBT-I for typically developing children using a 4-session digital intervention
Waitlist Control
Participants in the waitlist control will have delayed treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CBT-I
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Florida
Lead Sponsor