NCT04545606Recruiting
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 15 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 26 Aug 2020
- Start date
- 15 Sept 2020
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- University of Missouri-Columbia
- Diseases
- Autism
- NCT number
- NCT04545606
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 15 Sept 2020 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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)
- 10\) other conditions adversely affecting trial participation
Other
- 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
- 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)
Who the study is looking for
- 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
Age in the registry: 6 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thompson Center for Autism and Neurodevelopmental Disorders Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.