Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Eligible age
6–12 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Missouri-Columbia
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 \[ADI-R\])
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
Where it's recruiting
Columbia
Source: ClinicalTrials.gov · NCT04545606 · last updated 2024-03-15