Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT04545606
Eligibility Criteria:
Inclusion Criteria:
* 1\) 6-12a yrs
* 2\) Verbal IQ \>= 70
* 3\) participation of child's parent or legal guardian living in the same home
* 4\) parent/guardian ability to read and understand English at the 5th-grade level
* 5\) child diagnosed with ASD and insomnia
ASD:
* 1\) previous DSM diagnosis of ASD
* 2\) evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised \[ADI-R\])
Insomnia:
* 1\) complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
* 2\) daytime dysfunction (mood, cognitive, social, academic) due to insomnia
* 3\) baseline diaries and actigraphy indicate \>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights
Exclusion Criteria:
* 1\) parent unable to provide informed consent or child unable to provide assent
* 2\) unwilling to accept random assignment
* 3\) participation in another randomized research project
* 4\) parent unable to complete forms or implement treatment procedures due to cognitive impairment
* 5\) untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
* 6\) 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\) stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
* 8\) participation in non-pharmacological treatment (including CBT) for sleep outside current trial
* 9\) parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
* 10\) other conditions adversely affecting trial participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT04545606
Study Brief:
Protocol Section:
NCT04545606