NCT04545606 · University of Missouri-Columbia
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
(RECHArge)
What this study 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).
View original scientific 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.
Interventions
BEHAVIORAL
In-Person CBT for insomnia in children with autism
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
BEHAVIORAL
Remote CBT for insomnia in children with autism
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
BEHAVIORAL
Remote sleep hygiene and related education (SHARE) for insomnia in children with autism
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
Primary outcome measures
Baseline Average Objective Sleep Efficiency for the child
Time frame: 24/7 during each 2 week assessment at Baseline
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention
Time frame: 24/7 during each 2 week assessment immediately after the intervention
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Sleep Efficiency for the child from baseline to 6 months
Time frame: 24/7 during each 2 week assessment at 6 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Sleep Efficiency for the child from baseline to 12 months
Time frame: 24/7 during each 2 week assessment at 12 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Baseline Average Bed/Waketime Variability for the child
Time frame: 24/7 during each 2 week assessment at Baseline
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention
Time frame: 24/7 during each 2 week assessment immediately after the intervention
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Change in Average Bed/Waketime Variability for the child from baseline to 6 months
Time frame: 24/7 during each 2 week assessment at 6 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Change in Average Bed/Waketime Variability for the child from baseline to 12 months
Time frame: 24/7 during each 2 week assessment at 12 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child
Time frame: 8 minute protocol during rest at Baseline (in clinic)
Child arousal measured by Holter Monitors, 8 min ECG
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to immediately after the intervention
Time frame: 8 minute protocol during rest immediately after the intervention (in clinic)
Child arousal measured by Holter Monitors, 8 min ECG
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 6 months
Time frame: 8 minute protocol during rest at 6 month follow up (in clinic)
Child arousal measured by Holter Monitors, 8 min ECG
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 12 months
Time frame: 8 minute protocol during rest at 12 month follow up (in clinic)
Child arousal measured by Holter Monitors, 8 min ECG
Baseline Average Objective Total Sleep Time for the parent
Time frame: 24/7 during each 2 week assessment at Baseline
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Total Sleep Time for the parent from baseline to immediately after the intervention
Time frame: 24/7 during each 2 week assessment immediately after the intervention
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Total Sleep Time for the parent from baseline to 6 months
Time frame: 24/7 during each 2 week assessment at 6 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Total Sleep Time for the parent from baseline to 12 months
Time frame: 24/7 during each 2 week assessment at 12 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- 9\) parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
- 10\) other conditions adversely affecting trial participation
Where
- Columbia, Missouri
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 15, 2024 · Source of record for eligibility and locations