What this study is
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.
What's being tested
- In-Person CBT for insomnia in children with autism
Intervention · BEHAVIORAL
7 modules administered in-person 1. Sleep Hygiene \& Sleep Prescription 2. Bedtime Routine \& Parent Management 3. Cue Control \& Parent Management 4. Co-Sleeping \& Parents Fading out of Room 5. Circadian Education, Morning Routine, \& Relaxation 6. Cognitive Therapy Basics 7. Nighttime Fears, Anxiety, \& Nightmares
- Remote CBT for insomnia in children with autism
Intervention · BEHAVIORAL
7 modules administered over telehealth/videoconferencing 1. Sleep Hygiene \& Sleep Prescription 2. Bedtime Routine \& Parent Management 3. Cue Control \& Parent Management 4. Co-Sleeping \& Parents Fading out of Room 5. Circadian Education, Morning Routine, \& Relaxation 6. Cognitive Therapy Basics 7. Nighttime Fears, Anxiety, \& Nightmares
- Remote sleep hygiene and related education (SHARE) for insomnia in children with autism
Intervention · BEHAVIORAL
7 modules administered over telehealth/videoconferencing 1. Sleep Education 2. Sleep Architecture \& Parasomnias 3. Physical Activity \& Sleep 4. Nutrition, My Plate, \& Breathing during Sleep 5. Stress, Sleep, Dreams, \& Nightmares Connections 6. Mood, Self-Esteem, \& Sleep 7. Light \& Dark Cycle
Study details
- Sponsor
- University of Missouri-Columbia
- Conditions
- Insomnia Chronic · Autism Spectrum Disorder
- Enrolling
- 180 people
- Starts
- 2020-09-15
- Est. completion
- 2030-08
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years – 12 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 6-12a yrs
- Verbal IQ >= 70
- Participation of child's parent or legal guardian living in the same home
- Parent/guardian ability to read and understand English at the 5th-grade level
- Child diagnosed with ASD and insomnia ASD:; previous DSM diagnosis of ASD; evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised [ADI-R]) Insomnia:; complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos; daytime dysfunction (mood, cognitive, social, academic) due to insomnia; 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
You can't join if
- Parent unable to provide informed consent or child unable to provide assent
- Unwilling to accept random assignment
- Participation in another randomized research project
- Parent unable to complete forms or implement treatment procedures due to cognitive impairment
- Untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias)
- 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)
- Stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
- Participation in non-pharmacological treatment (including CBT) for sleep outside current trial
- Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
- Other conditions adversely affecting trial participation
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThompson Center for Autism and Neurodevelopmental Disorders
Columbia, Missouri, United States
- Nicole Takahashi · Contact573-884-1893TakahashiN@health.missouri.edu
Recruiting
Study team
Sponsor
University of Missouri-Columbia
Study ID 2019182
Principal investigator
Christina S McCrae, PhD
University of Missouri-Columbia
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.