RecruitingNot ApplicableNCT07091149

Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr

Sponsor

University of South Florida

Enrollment

40 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.

Min Age: 6 YearsMax Age: 12 Years

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
ability to read and understand English at the 5th grade level
willing to accept random assignment.

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 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 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 participation in non-pharmacological treatment (including CBT) for sleep outside current trial
child other conditions adversely affecting trial participation.
unable to provide informed consent
unwilling to accept random assignment
caregiver participation in another randomized research project
unable to complete forms or implement treatment procedures due to cognitive impairment
caregiver participation in non-pharmacological treatment (including CBT) for sleep outside current trial