Purpose

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

Condition

Eligibility

Eligible Ages
Between 6 Years and 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Participants will be randomized to either CBT-I or a waitlist control
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CBT-I
Immediate CBT-I for typically developing children using a 4-session digital intervention.
  • Behavioral: CBT-I
    Cognitive behavioral therapy for insomnia
Other
Waitlist Control
Participants in the waitlist control will have delayed treatment (4 weeks later).
  • Behavioral: CBT-I
    Cognitive behavioral therapy for insomnia

Recruiting Locations

University of South Florida
Tampa, Florida 33612
Contact:
Christina S McCrae, PhD

More Details

Status
Recruiting
Sponsor
University of South Florida

Study Contact

Britani Holland, PhD
813-974-1804
blalone@usf.eduJ

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.