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

NCT07091149 | Recruiting

• 1 other identifier: STUDY006258
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia

Keywords

dCBTi; digital intervention; insomnia; children

Outcome Measures

Primary Outcomes (7)

• Electronic Sleep Diaries - Child

  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.

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

• Actigraphy - Child

  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.

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

• Session Completion

  Percentage of treatment sessions completed

  within 1 week post-treatment

• Treatment Adherence

  Percentage of instructions followed as indicated on treatment adherence logs

  within 1 week post-treatment

• Internet Intervention Utility Questionnaire (IIUQ)

  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.

  within 1 week post-treatment

• Treatment Satisfaction Survey

  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

  within 1 week post-treatment

• Pediatric Insomnia Severity Index

  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.

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

Secondary Outcomes (16)

• Child Sleep Habits Questionnaire-Abbreviated

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

• Pediatric Symptom Checklist-17

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

• Behavior Rating Inventory of Executive Function -2nd Edition (BRIEF-2)

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

• Pediatric Daytime Sleepiness Scale

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

• Revised Children's Anxiety and Depression Scale-25

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

Other Outcomes (1)

• Pubertal Development Scale (PDS)

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

Study Arms (2)

CBT-I

EXPERIMENTAL

Immediate CBT-I for typically developing children using a 4-session digital intervention.

Behavioral: CBT-I

Waitlist Control

OTHER

Participants in the waitlist control will have delayed treatment (4 weeks later).

Behavioral: CBT-I

Interventions

CBT-I BEHAVIORAL

Cognitive behavioral therapy for insomnia

CBT-I; Waitlist Control

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Christina S McCrae, PhD

CONTACT

813-974-1804; christinamccrae@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized to either CBT-I or a waitlist control

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: July 29, 2025
• Study Start: April 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

US (1)