Improving sleep in children with autism and insomnia
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
This study is testing a new sleep therapy for children with autism and insomnia to see if it can help them sleep better and feel more awake during the day.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT04545606 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-12 years with a diagnosis of Autism Spectrum Disorder and insomnia, along with their parent or guardian.
Not a fit: Patients who do not have a diagnosis of ASD or insomnia, or those unable to participate due to language barriers or lack of parental consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sleep quality for children with autism, leading to better daytime behavior and overall family well-being.
How similar studies have performed: Previous studies have shown promise in using behavioral therapies for sleep issues in children, but this specific approach for children with autism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbia, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.