NCT07091149 · University of South Florida
Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
(NiteCAPP JR)
What this study is about
The proposed pilot will examine feasibility, acceptability, and preliminary effectiveness of a digital CBT-I tailored for school-aged children.
View original scientific description
The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.
Interventions
BEHAVIORAL
CBT-I
Cognitive behavioral therapy for insomnia
Primary outcome measures
Electronic Sleep Diaries - Child
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Primary: child sleep onset latency (lights-out until sleep onset) and total sleep time. All other sleep diary variables are secondary (e.g., sleep efficiency (total sleep time/time in bed x 100%). Child (with caregiver assistance) and caregiver complete electronic diaries each morning (\~5 mins) during each 1-week assessment and throughout treatment.
Actigraphy - Child
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Primary variables: child sleep onset latency and total sleep time. All other actigraphy variables are secondary. Children wear actigraphs (Fitbit Inspire 3, Google), watch-like device, that monitors light and gross motor activity. Data analyzed using 30s epochs. Validated algorithm estimates SOL, TST, WASO, sleep efficiency and other variables provided by diaries. A combination of diary and actigraphy data estimates bed/waketime variability. Children wear devices 24/7 during each 1-week assessment.
Session Completion
Time frame: within 1 week post-treatment
Percentage of treatment sessions completed
Treatment Adherence
Time frame: within 1 week post-treatment
Percentage of instructions followed as indicated on treatment adherence logs
Internet Intervention Utility Questionnaire (IIUQ)
Time frame: within 1 week post-treatment
16-item measure designed to assess usability, likeability, usefulness, understandability, and convenience of an Internet intervention using a 5-point Likert scale, ranging from 0 (not at all) to 4 (very). Two additional open-ended questions ask about the most and least helpful aspects of the program. Scoring range is 0-64.
Treatment Satisfaction Survey
Time frame: within 1 week post-treatment
9-item measure designed to provide feedback on the study, including its structure, assessments, scheduling, working with study staff, and the usability of the intervention platforms using a 10-point Likert scale, ranging from 1 (strongly disagree) to 10 (strongly agree) and open-ended questions
Pediatric Insomnia Severity Index
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
The Pediatric Insomnia Severity Index is a six-item questionnaire that assesses insomnia symptom severity in children 4-10 years old. Items are rated on a 0-6 point scale based on the child's sleep over the past week. Scoring range is 0-30 with with higher scores indicating greater insomnia severity.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Child inclusion:
- 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. 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:
- ability to read and understand English at the 5th grade level
- willing to accept random assignment.
Exclusion criteria
- Child exclusion:
- 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)
- 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)
- child stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
- child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
- child other conditions adversely affecting trial participation. Caregiver exclusion criteria:
- unable to provide informed consent
- unwilling to accept random assignment
- caregiver participation in another randomized research project
- unable to complete forms or implement treatment procedures due to cognitive impairment
- caregiver participation in non-pharmacological treatment (including CBT) for sleep outside current trial
Where
- Tampa, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations