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Taking people in United StatesNo phase
Online sleep program for school-aged children with insomnia
Tests a digital sleep treatment for children with insomnia.
Key facts
- Who runs it
- University of South Florida
- Where
- Tampa, United StatesSee the site
- Trial code
- Registry title
- Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 10 Apr 2025
- Expected to end
- 1 May 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- CBT-I
- Record updated
- 11 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 6 to 12 with insomnia, together with a parent or guardian. It tests a digital sleep therapy program (CBT-I) for school-aged children.
- Age
- 6 to 12 years
- Sex
- All
- Disease stage
- Insomnia for 3+ months: trouble falling asleep, staying asleep or waking too early. It must also cause problems during the day. Pediatric Insomnia Severity Index score must be >8.
- Earlier treatment
- Children cannot join if they took stimulants, sleep medicines or melatonin in the last 1 month, unless their dose has been stable for 3+ months. Children cannot join if they get non-drug sleep treatment (including CBT) outside this trial.
- Biomarker or test result
- Verbal IQ > 70. A parent or guardian living in the same home must take part and read English at a 5th grade level.
Main reasons for not taking part
- Untreated other health problems, such as other sleep disorders (e.g., apnea), epilepsy, psychotic disorders or suicidal thoughts
- Medicines that change sleep, other than the allowed stimulants, sleep medicines or melatonin
- Taking part in another randomized research study
- Not able to fill in forms or follow the treatment because of thinking problems
- Child or caregiver not willing to be placed in a group by chance
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- Child inclusion:
- 6-12 yrs
- Verbal IQ > 70 (to ensure verbal skills are sufficient to participate in treatment)
- participation of child's parent or legal guardian living in the same home
- child diagnosed with insomnia, 5) willing to accept random assignment; Insomnia:
- insomnia complaints for 3+ months by child report or caregiver observation that consist of (a) difficulties falling asleep, staying asleep, and/or waking up too early, (b) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, and (c) Pediatric Insomnia Severity Index score >8; Caregiver inclusion:
- ability to read and understand English at the 5th grade level
- willing to accept random assignment
Who cannot take part
- child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin as described in #7 (see Notes below for details)
- child stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
- child unable to complete forms or implement treatment procedures due to cognitive impairment
- child untreated medical comorbidity including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias)
- child other conditions adversely affecting trial participation; Caregiver exclusion criteria:
- unable to complete forms or implement treatment procedures due to cognitive impairment
- Child exclusion:
- child unable to provide informed consent or child unable to provide assent
- child unwilling to accept random assignment
- child participation in another randomized research project
- child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
- unable to provide informed consent
- unwilling to accept random assignment
- caregiver participation in another randomized research project
- caregiver participation in non-pharmacological treatment (including CBT) for sleep outside current trial
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 12 years old?
Where in United States
- University of South FloridaTampa, United StatesContact: Christina S McCrae, PhDTaking people
About the trial
What the trial wants to find out
The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.
The 2 groups in the trial
- CBT-ITreatment being tested
Immediate CBT-I for typically developing children using a 4-session digital intervention.
- Waitlist ControlOther group
Participants in the waitlist control will have delayed treatment (4 weeks later).
Treatment: CBT-I
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
- Plain-language title
- Online sleep program for school-aged children with insomniaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07091149, who can take part
- Publications
- Record updated
- 11 September 2026