Testing Sleep Therapy for Insomnia in School-Aged Children With Autism
Tests behavioral sleep therapy for chronic insomnia in children with autism aged 6 to 12.
Plain-language title generated from the registry record
Registry title: Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Key facts
- Where
- Columbia, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 12 years old?
Source: NCT04545606, who can take part
Where in United States
- Thompson Center for Autism and Neurodevelopmental DisordersColumbia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Missouri-Columbia
- Trial code
- NCT04545606
- Record updated
- 15 March 2024
- Original description
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.Read full original descriptionShow less
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
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.
Inclusion: 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: 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); 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; 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).