Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Insomnia Chronic
- Sponsor
- University of Missouri-Columbia
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
Children with autism often have difficulties falling and staying asleep at night. Those sleep difficulties can contribute to daytime problems with irritability, learning, and behavior. Parents are often stressed about their child's sleep difficulties and as a result, their sleep can suffer as well. Treatment that focuses on establishing behaviors and routines that help reduce arousal and support good sleep are helpful for improving the sleep of children without autism, but have not yet been tested in children with autism. Previous studies have indicated that distance can make it difficult for families to participate in treatment. As such, we will conduct treatment remotely for two of treatment arms. Having remote versions of the treatment can expand the number of children and families that are able to receive these promising treatments. This may be particularly important for children with ASD living in rural and underserved areas as well as those in military families that may not have access to a healthcare provider with training in behavioral sleep treatments.
Investigators
Christina McCrae
Professor, Psychiatry
University of Missouri-Columbia
Eligibility Criteria
Inclusion Criteria
- •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
- •previous DSM diagnosis of ASD
- •evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised \[ADI-R\])
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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 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 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 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 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
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 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 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 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 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 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
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
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 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
Secondary Outcomes
- Baseline Aberrant Behavior Checklist (ABC) for the child(Baseline)
- Aberrant Behavior Checklist (ABC) for the child immediately after the intervention(Immediately after the intervention)
- Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 6 months(At 6 month follow up)
- Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 12 months(At 12 month follow up)
- Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) immediately after the intervention(Immediately after the intervention)
- Aberrant Behavior Checklist (ABC) for the child at 6 months(At 6 month follow up)
- Aberrant Behavior Checklist (ABC) for the child at 12 months(At 12 month follow up)
- Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) immediately after the intervention(Immediately after the intervention)
- Baseline Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7)(Baseline)
- Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 6 months(At 6 month follow up)
- Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 12 months(At 12 month follow up)
- Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child immediately after the intervention(Immediately after the intervention)
- Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 12 months(At 12 month follow up)
- Child Quality of Life: PedsQL Child Form for the child at 6 months(At 6 month follow up)
- Child Quality of Life: PedsQL Parent Form for the child at 12 months(At 12 month follow up)
- Change in Average Subjective Total Wake Time for the child from baseline to immediately after the intervention(Each morning for 2 weeks immediately after the intervention)
- Baseline Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+)(Baseline)
- Child Quality of Life: PedsQL Child Form for the child immediately after the intervention(Immediately after the intervention)
- Child Quality of Life: PedsQL Child Form for the child at 12 months(At 12 month follow up)
- Baseline Average Subjective Sleep Onset Latency for the child(Each morning for 2 weeks at Baseline)
- Change in Average Subjective Sleep Onset Latency for the child from baseline to 6 months(Each morning for 2 weeks at 6 month follow up)
- Change in Average Subjective Sleep Onset Latency for the child from baseline to 12 months(Each morning for 2 weeks at 12 month follow up)
- Change in Average Subjective Total Wake Time for the child from baseline to 6 months(Each morning for 2 weeks at 6 month follow up)
- Change in Average Subjective Total Sleep Time for the child from baseline to 12 months(Each morning for 2 weeks at 12 month follow up)
- Baseline Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child(Baseline)
- Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 6 months(At 6 month follow up)
- Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 6 months(At 6 month follow up)
- Baseline Child Quality of Life: PedsQL Parent Form for the child(Baseline)
- Child Quality of Life: PedsQL Parent Form for the child immediately after the intervention(Immediately after the intervention)
- Change in Average Subjective Sleep Onset Latency for the child from baseline to immediately after the intervention(Each morning for 2 weeks immediately after the intervention)
- Baseline Average Subjective Total Sleep Time for the child(Each morning for 2 weeks at Baseline)
- Change in Average Subjective Total Sleep Time for the child from baseline to immediately after the intervention(Each morning for 2 weeks immediately after the intervention)
- Baseline Average LF/HF ratio for the child(8 minute protocol during rest at Baseline (in clinic))
- Baseline Average pNN50 (% of N-N intervals > 50 ms) for the child(8 minute protocol during rest at Baseline (in clinic))
- Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 12 months(8 minute protocol during rest at 12 month follow up (in clinic))
- Baseline Child Quality of Life: PedsQL Child Form for the child(Baseline)
- Child Quality of Life: PedsQL Parent Form for the child at 6 months(At 6 month follow up)
- Baseline Average Subjective Total Wake Time for the child(Each morning for 2 weeks at Baseline)
- Change in Average Subjective Sleep Efficiency for the child from baseline to 6 months(Each morning for 2 weeks at 6 month follow up)
- Change in Average LF/HF ratio for the child from baseline to 6 months(8 minute protocol during rest at 6 month follow up (in clinic))
- Change in Average LF/HF ratio for the parent from baseline to immediately after the intervention(8 minute protocol during rest immediately after the intervention (in clinic))
- Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 12 months(8 minute protocol during rest at 12 month follow up (in clinic))
- State-Trait Anxiety Inventory (STAI-Y1) for the parent at 12 months(At 12 month follow up)
- Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 12 months(At 12 month follow up)
- Baseline Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child(Baseline)
- Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child immediately after the intervention(Immediately after the intervention)
- Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to immediately after the intervention(8 minute protocol during rest immediately after the intervention (in clinic))
- Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 6 months(8 minute protocol during rest at 6 month follow up (in clinic))
- Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent(8 minute protocol during rest at Baseline (in clinic))
- Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 6 months(8 minute protocol during rest at 6 month follow up (in clinic))
- Baseline State-Trait Anxiety Inventory (STAI-Y1) for the parent(Baseline)
- Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 12 months(8 minute protocol during rest at 12 month follow up (in clinic))
- Baseline Average LF/HF ratio for the parent(8 minute protocol during rest at Baseline (in clinic))
- Change in Average Subjective Total Wake Time for the child from baseline to 12 months(Each morning for 2 weeks at 12 month follow up)
- Change in Average Subjective Total Sleep Time for the child from baseline to 6 months(Each morning for 2 weeks at 6 month follow up)
- Baseline Average Subjective Sleep Efficiency for the child(Each morning for 2 weeks at Baseline)
- Change in Average Subjective Sleep Efficiency for the child from baseline to immediately after the intervention(Each morning for 2 weeks immediately after the intervention)
- Change in Average Subjective Sleep Efficiency for the child from baseline to 12 months(Each morning for 2 weeks at 12 month follow up)
- Change in Average LF/HF ratio for the child from baseline to immediately after the intervention(8 minute protocol during rest immediately after the intervention (in clinic))
- Change in Average LF/HF ratio for the child from baseline to 12 months(8 minute protocol during rest at 12 month follow up (in clinic))
- Change in Average LF/HF ratio for the parent from baseline to 6 months(8 minute protocol during rest at 6 month follow up (in clinic))
- Change in Average LF/HF ratio for the parent from baseline to 12 months(8 minute protocol during rest at 12 month follow up (in clinic))
- Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to immediately after the intervention(8 minute protocol during rest immediately after the intervention (in clinic))
- Baseline Average pNN50 (% of N-N intervals > 50 ms) for the parent(8 minute protocol during rest at Baseline (in clinic))
- Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to immediately after the intervention(8 minute protocol during rest immediately after the intervention (in clinic))
- Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 6 months(8 minute protocol during rest at 6 month follow up (in clinic))
- Fatigue Severity Scale for the parent at 6 months(At 6 month follow up)
- Daily Fatigue for the parent at 12 months(At 12 month follow up)
- Baseline Average Subjective Total Sleep Time for the parent(Each morning for 2 weeks at Baseline)
- State-Trait Anxiety Inventory (STAI-Y1) for the parent immediately after the intervention(Immediately after the intervention)
- State-Trait Anxiety Inventory (STAI-Y1) for the parent at 6 months(At 6 month follow up)
- Beck Depression Inventory (BDI-II) for the parent immediately after the intervention(Immediately after the intervention)
- Baseline Fatigue Severity Scale for the parent(Baseline)
- Fatigue Severity Scale for the parent at 12 months(At 12 month follow up)
- Daily Fatigue for the parent immediately after the intervention(Immediately after the intervention)
- Daily Fatigue for the parent at 6 months(At 6 month follow up)
- Baseline Caregiver Strain Index (CSI) for the parent(Baseline)
- Caregiver Strain Index (CSI) for the parent immediately after the intervention(Immediately after the intervention)
- Caregiver Strain Index (CSI) for the parent at 12 months(At 12 month follow up)
- Change in Average Subjective Sleep Onset Latency for the parent from baseline to 12 months(Each morning for 2 weeks at 12 month follow up)
- Baseline Beck Depression Inventory (BDI-II) for the parent(Baseline)
- Beck Depression Inventory (BDI-II) for the parent at 6 months(At 6 month follow up)
- Fatigue Severity Scale for the parent immediately after the intervention(Immediately after the intervention)
- Baseline Daily Fatigue for the parent(Baseline)
- Change in Average Subjective Sleep Onset Latency for the parent from baseline to 6 months(Each morning for 2 weeks at 6 month follow up)
- Baseline Average Subjective Total Wake Time for the parent(Each morning for 2 weeks at Baseline)
- Change in Average Subjective Total Sleep Time for the parent from baseline to immediately after the intervention(Each morning for 2 weeks immediately after the intervention)
- Baseline Average Subjective Sleep Efficiency for the parent(Each morning for 2 weeks at Baseline)
- Change in Average Subjective Sleep Efficiency for the parent from baseline to 6 months(Each morning for 2 weeks at 6 month follow up)
- Beck Depression Inventory (BDI-II) for the parent at 12 months(At 12 month follow up)
- Caregiver Strain Index (CSI) for the parent at 6 months(At 6 month follow up)
- Change in Average Subjective Sleep Onset Latency for the parent from baseline to immediately after the intervention(Each morning for 2 weeks immediately after the intervention)
- Change in Average Subjective Total Sleep Time for the parent from baseline to 6 months(Each morning for 2 weeks at 6 month follow up)
- Change in Average Subjective Total Sleep Time for the parent from baseline to 12 months(Each morning for 2 weeks at 12 month follow up)
- Change in Average Subjective Sleep Efficiency for the parent from baseline to 12 months(Each morning for 2 weeks at 12 month follow up)
- Baseline Average Subjective Sleep Onset Latency for the parent(Each morning for 2 weeks at Baseline)
- Change in Average Subjective Total Wake Time for the parent from baseline to immediately after the intervention(Each morning for 2 weeks immediately after the intervention)
- Change in Average Subjective Total Wake Time for the parent from baseline to 6 months(Each morning for 2 weeks at 6 month follow up)
- Change in Average Subjective Total Wake Time for the parent from baseline to 12 months(Each morning for 2 weeks at 12 month follow up)
- Change in Average Subjective Sleep Efficiency for the parent from baseline to immediately after the intervention(Each morning for 2 weeks immediately after the intervention)