Improving sleep in children with autism and insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to help children with Autism Spectrum Disorder (ASD) who also suffer from insomnia by providing behavioral therapy focused on improving sleep. Participants will undergo four sessions of therapy, followed by four booster sessions, with families randomly assigned to either in-person or remote therapy options. The study will measure sleep quality and related behaviors over time, assessing the effectiveness of these interventions in both improving sleep and reducing daytime dysfunction. The inclusion of remote therapy options aims to increase accessibility for families, particularly those in underserved areas.

Why it matters

Who can join: the full rules

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

Where it's running

• Thompson Center for Autism and Neurodevelopmental Disorders
  Columbia, Missouri, United States Recruiting

Study contacts

• Principal investigator: Christina S McCrae, PhD — University of Missouri-Columbia
• Study coordinator: Melanie Stearns, PhD
• Email: mastearns@health.missouri.edu
• Phone: 859-327-7762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.