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

Recruiting now · Not applicable

Conditions studied: Insomnia

In brief

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

Key facts

Study ID

NCT07091149

Run by

University of South Florida

People needed

40

Starts

2025-04-10

Expected to finish

2027-05-01

Last updated by the study team

2026-06-15

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 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.
• Caregiver exclusion criteria:
• 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

Where it is running

• University of South Florida — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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