NiteCAPP Jr: a digital CBT sleep program for kids aged 6–12 with insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of South Florida
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Christina McCrae — University of South Florida
• Study coordinator: Britani Holland, PhD
• Email: blalone@usf.eduJ
• Phone: 813-974-1804

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.