Columbia, Missouri 65201

  • Autism Spectrum Disorder

Purpose:

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.


Study summary:

Children with autism often have difficulties falling and staying asleep at night. Those sleep difficulties can contribute to daytime problems with irritability, learning, and behavior. Parents are often stressed about their child's sleep difficulties and as a result, their sleep can suffer as well. Treatment that focuses on establishing behaviors and routines that help reduce arousal and support good sleep are helpful for improving the sleep of children without autism, but have not yet been tested in children with autism. Previous studies have indicated that distance can make it difficult for families to participate in treatment. As such, we will conduct treatment remotely for two of treatment arms. Having remote versions of the treatment can expand the number of children and families that are able to receive these promising treatments. This may be particularly important for children with ASD living in rural and underserved areas as well as those in military families that may not have access to a healthcare provider with training in behavioral sleep treatments.


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


NCT ID:

NCT04545606


Primary Contact:

Principal Investigator
Christina S McCrae, PhD
University of Missouri-Columbia

Melanie Stearns, PhD
Phone: 859-327-7762
Email: mastearns@health.missouri.edu


Backup Contact:

Email: rstephens@health.missouri.edu
Riley Stephens
Phone: 573-882-8881


Location Contact:

Columbia, Missouri 65201
United States

Nicole Takahashi
Phone: 573-884-1893
Email: TakahashiN@health.missouri.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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