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Recruiting NCT07091149

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

Trial Parameters

Condition Insomnia
Sponsor University of South Florida
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 6 Years
Max Age 12 Years
Start Date 2025-04-10
Completion 2025-12-01
Interventions
CBT-I

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: 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: 1. ability to read and understand English at the 5th grade level 2. willing to accept random assignment. Exclusion Criteria: 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

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