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Recruiting NCT07091149

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

No phase Interventional Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CBT-I.
Who it may be relevant to
Registry conditions: Insomnia. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

This is a pilot study to examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children aged 6-12 with insomnia and their caregiver(s) compared to a waitlist control.

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]
  • Actigraphy - Child [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Session Completion [Time frame: within 1 week post-treatment]
  • Treatment Adherence [Time frame: within 1 week post-treatment]
  • Internet Intervention Utility Questionnaire (IIUQ) [Time frame: within 1 week post-treatment]
  • Treatment Satisfaction Survey [Time frame: within 1 week post-treatment]
  • Pediatric Insomnia Severity Index [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
Secondary outcome measures (12)
  • Child Sleep Habits Questionnaire-Abbreviated [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Pediatric Symptom Checklist-17 [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Behavior Rating Inventory of Executive Function -2nd Edition (BRIEF-2) [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Pediatric Daytime Sleepiness Scale [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Revised Children's Anxiety and Depression Scale-25 [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Strengths and Difficulties Questionnaire [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Heart rate variability - Child [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Peds Quality of Life [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Heart rate variability - Caregiver [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Actigraphy - Caregiver [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • Electronic Sleep Diaries - Caregiver [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
  • State-Trait Anxiety Inventory (STAI-Y1) - Caregiver [Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]

Eligibility criteria

Inclusion criteria

Child inclusion:

  • 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of South Florida — Tampa

Publications

  • McCrae CS, Stearns MA, Mazurek MO, Page J, Holland B, Takagishi J, Emmanual P, Zhang X, Kapolka M, Craggs C, Gonzalez D, Owens J. Digital Cognitive Behavioral Treatment of Insomnia in Youth: Protocol for an RCT Examining Feasibility, Acceptability, and Efficacy of LAMBI. Behav Sleep Med. 2026 May 28:1-15. doi: 10.1080/15402002.2026.2667840. Online ahead of print. PMID 42210669

Identifiers

NCT: NCT07091149 · STUDY006258

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗