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