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

NCT ID: NCT07091149

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-12-01

Brief Summary

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT-I

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

Group Type: EXPERIMENTAL

CBT-I

Intervention Type: BEHAVIORAL

Cognitive behavioral therapy for insomnia

Waitlist Control

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

Group Type: OTHER

CBT-I

Intervention Type: BEHAVIORAL

Cognitive behavioral therapy for insomnia

Interventions

CBT-I

Cognitive behavioral therapy for insomnia

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Christina McCrae

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of South Florida

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christina S McCrae, PhD

Role: CONTACT

christinamccrae@usf.edu

813-974-1804

Facility Contacts

Christina S McCrae, PhD

Role: primary

Other Identifiers

STUDY006258

Identifier Type: -

Identifier Source: org_study_id