Actively Recruiting
Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
Led by University of South Florida · Updated on 2025-07-29
40
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.
CONDITIONS
Official Title
Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is between 6 and 12 years old
- Child has a verbal IQ greater than 70
- Child's parent or legal guardian lives in the same home and participates
- Child has a diagnosis of insomnia
- Child has insomnia symptoms for 3 or more months including trouble falling asleep, staying asleep, or waking too early
- Child experiences daytime problems due to insomnia such as mood, cognitive, social, or occupational difficulties
- Pediatric Insomnia Severity Index score greater than 8
- Caregiver can read and understand English at a 5th grade level
- Both child and caregiver are willing to accept random assignment to study groups
You will not qualify if you...
- Child unable to provide informed consent or assent
- Child unwilling to accept random assignment
- Child is participating in another randomized research study
- Child unable to complete forms or follow treatment due to cognitive impairment
- Child has untreated medical conditions affecting sleep such as apnea, epilepsy, psychotic disorders, suicidal thoughts, or frequent parasomnias
- Child uses psychotropic or other medications that affect sleep except stimulants, sleep medications, or melatonin under specified conditions
- Child has taken stimulants, sleep medications, or melatonin within the last month unless stable for 3 or more months
- Child is receiving non-drug treatments for sleep outside this trial
- Child has other conditions that would interfere with study participation
- Caregiver unable to provide informed consent
- Caregiver unwilling to accept random assignment
- Caregiver is in another randomized research study
- Caregiver unable to complete forms or follow procedures due to cognitive impairment
- Caregiver is receiving non-drug treatments for sleep outside this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
C
Christina S McCrae, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here