NCT07091149 Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
| NCT ID | NCT07091149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-04-10 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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) 8. child participation in non-pharmacological treatment (including CBT) for sleep outside current trial 9. child other conditions adversely affecting trial participation. Caregiver exclusion criteria: 1. unable to provide informed consent 2. unwilling to accept random assignment 3. caregiver participation in another randomized research project 4. unable to complete forms or implement treatment procedures due to cognitive impairment 5. caregiver participation in non-pharmacological treatment (including CBT) for sleep outside current trial
Contact & Investigator
Christina McCrae
PRINCIPAL INVESTIGATOR
University of South Florida
Frequently Asked Questions
Who can join the NCT07091149 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07091149 currently recruiting?
Yes, NCT07091149 is actively recruiting participants. Contact the research team at blalone@usf.eduJ for enrollment information.
Where is the NCT07091149 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT07091149 clinical trial?
NCT07091149 is sponsored by University of South Florida. The principal investigator is Christina McCrae at University of South Florida. The trial plans to enroll 40 participants.
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