RecruitingInsomnia

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

Eligible age

6–12 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

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

Sponsor: University of South Florida

✓ Child inclusion:
✓ 1. 6-12 yrs
✓ 2. Verbal IQ \> 70 (to ensure verbal skills are sufficient to participate in treatment)
✓ 3. participation of child's parent or legal guardian living in the same home
✓ 4. child diagnosed with insomnia, 5) willing to accept random assignment.
✓ Insomnia:
✓ 1\) 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:

✕ Child exclusion:
✕ 1. child unable to provide informed consent or child unable to provide assent
✕ 2. child unwilling to accept random assignment
✕ 3. child participation in another randomized research project
✕ 4. child unable to complete forms or implement treatment procedures due to cognitive impairment
✕ 5. child untreated medical comorbidity including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
✕ 6. 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)
✕ 7. child stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)

Tampa

Source: ClinicalTrials.gov · NCT07091149 · last updated 2026-06-15