NiteCAPP Jr: a digital CBT sleep program for kids aged 6–12 with insomnia
Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
This will test whether a digital cognitive behavioral therapy program called NiteCAPP Jr, delivered with caregiver support, can help children aged 6–12 who have insomnia compared with being on a waitlist.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT07091149 on ClinicalTrials.gov |
What this trial studies
This pilot randomized trial compares a tailored digital CBT-I program (NiteCAPP Jr) plus caregiver involvement to a waitlist control in school-aged children with insomnia. Children aged 6–12 with persistent insomnia and their parent or guardian living in the same home are randomized and complete baseline and follow-up measures. Primary aims are to measure feasibility and acceptability of the digital program and to estimate preliminary effects on sleep symptoms using standardized measures such as the Pediatric Insomnia Severity Index. The study is conducted at the University of South Florida (Tampa) and includes caregiver-reported and child-reported sleep and daytime functioning outcomes.
Who should consider this trial
Good fit: Ideal candidates are children aged 6–12 with insomnia for 3+ months (Pediatric Insomnia Severity Index score >8), who have a parent or legal guardian living in the same home and are willing to accept random assignment and participate in the program.
Not a fit: Children with verbal IQ ≤70, those unable to assent or consent, those already in another randomized trial, or families without an English-reading caregiver living in the same home may not be eligible or likely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the program could offer an accessible, caregiver-supported digital treatment that improves sleep for school-aged children with insomnia.
How similar studies have performed: Digital CBT-I has demonstrated benefits in adults and adolescents, but tailored digital interventions specifically for younger school-aged children are relatively novel and have limited prior randomized data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida
- University of South Florida — Tampa, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Christina S McCrae, PhD
- Email: christinamccrae@usf.edu
- Phone: 813-974-1804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.