Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Recruiting now · Not applicable

Conditions studied: Insomnia Chronic, Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT04545606

Run by

University of Missouri-Columbia

People needed

180

Starts

2020-09-15

Expected to finish

2030-08-01

Last updated by the study team

2024-03-15

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Thompson Center for Autism and Neurodevelopmental Disorders — Columbia, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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