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

University of South Florida

Status: Enrolling

Conditions: Insomnia

Treatments: Behavioral: CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT07091149

STUDY006258

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Caregiver exclusion criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

CBT-I

Experimental group

Description:

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

Treatment:

Behavioral: CBT-I

Waitlist Control

Other group

Description:

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

Treatment:

Behavioral: CBT-I