💬In plain words
What the trial is, and whether it could suit you
Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 4 sessions of behavioral therapy for sleep problems followed by 4 bimonthly booster sessions. Children and their families will be randomly assigned to one of three conditions: cognitive behavioral therapy (in-person), cognitive behavioral therapy (remote), or behavioral therapy (remote). Arousal will be measured through heart-rate variability. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline (weeks 1-2 before starting the treatment), post-treatment (weeks 6-8 from baseline), 6-month follow-up, and 12-month follow-up.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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