RecruitingNot Applicable

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

United States40 participantsStarted 2025-04-10

Plain-language summary

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

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. ability to read and understand English at the 5th grade level
. willing to accept random assignment.

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Electronic Sleep Diaries - Child

Timeframe: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up

Actigraphy - Child

Timeframe: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up

Session Completion

Timeframe: within 1 week post-treatment

Treatment Adherence

Timeframe: within 1 week post-treatment

Internet Intervention Utility Questionnaire (IIUQ)

Timeframe: within 1 week post-treatment

Treatment Satisfaction Survey

Timeframe: within 1 week post-treatment

Pediatric Insomnia Severity Index

Timeframe: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up

Trial details

NCT IDNCT07091149

SponsorUniversity of South Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

Christina S McCrae, PhD

813-974-1804 christinamccrae@usf.edu

View on ClinicalTrials.gov More Insomnia trials

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. ability to read and understand English at the 5th grade level
. willing to accept random assignment.

Exclusion criteria

. 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)

What they're measuring

Electronic Sleep Diaries - Child

Timeframe: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up

Actigraphy - Child

Timeframe: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up

Session Completion

Timeframe: within 1 week post-treatment

Treatment Adherence

Timeframe: within 1 week post-treatment

Internet Intervention Utility Questionnaire (IIUQ)

Timeframe: within 1 week post-treatment

Treatment Satisfaction Survey

Timeframe: within 1 week post-treatment

Pediatric Insomnia Severity Index

Timeframe: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up