Actively Recruiting
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Led by University of Missouri-Columbia · Updated on 2024-03-15
180
Participants Needed
1
Research Sites
515 weeks
Total Duration
On this page
Sponsors
U
University of Missouri-Columbia
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is between 6 and 12 years old
- Child has a verbal IQ of 70 or higher
- Child's parent or legal guardian lives in the same home and participates in the study
- Parent or guardian can read and understand English at a 5th-grade level
- Child has a diagnosis of Autism Spectrum Disorder confirmed by standard diagnostic tools (ADOS and/or ADI-R)
- Child has had insomnia symptoms (difficulty falling asleep, staying asleep, or early awakening) for 3 or more months
- Child experiences daytime problems due to insomnia such as mood, cognitive, social, or academic difficulties
- Sleep diaries and actigraphy show the child takes more than 30 minutes to fall asleep, wakes after sleep onset, or wakes early on at least 6 nights
You will not qualify if you...
- Parent cannot provide informed consent or child cannot provide assent
- Unwillingness to accept random assignment to treatment groups
- Participation in another randomized research study
- Parent unable to complete forms or carry out treatment due to cognitive impairment
- Untreated medical conditions including other sleep disorders like apnea, epilepsy, psychotic disorders, suicidal thoughts, or frequent parasomnias
- Use of psychotropic or other sleep-altering medications except stimulants, sleep medications, or melatonin under specific conditions
- Use of stimulants, sleep medications, or melatonin within the last month unless stabilized on them for 3 or more months
- Participation in sleep treatments outside this trial
- Parent reports child cannot tolerate Holter Monitoring or actigraphy due to sensitivity or behavioral issues
- Other conditions that would negatively affect participation in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Thompson Center for Autism and Neurodevelopmental Disorders
Columbia, Missouri, United States, 65201
Actively Recruiting
Research Team
M
Melanie Stearns, PhD
CONTACT
S
Sydney Shoemaker, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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