Clinical trial NCT04545606: Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Official title: Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Chronic
Autism Spectrum Disorder
Keywords: cognitive behavioral therapy, behavioral therapy
children
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-09-11
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Baseline Average Objective Sleep Efficiency for the child
timeFrame: 24/7 during each 2 week assessment at Baseline
measure: Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention
timeFrame: 24/7 during each 2 week assessment immediately after the intervention
measure: Change in Average Objective Sleep Efficiency for the child from baseline to 6 months
timeFrame: 24/7 during each 2 week assessment at 6 month follow up
measure: Change in Average Objective Sleep Efficiency for the child from baseline to 12 months
timeFrame: 24/7 during each 2 week assessment at 12 month follow up
measure: Baseline Average Bed/Waketime Variability for the child
timeFrame: 24/7 during each 2 week assessment at Baseline
measure: Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention
timeFrame: 24/7 during each 2 week assessment immediately after the intervention
measure: Change in Average Bed/Waketime Variability for the child from baseline to 6 months
timeFrame: 24/7 during each 2 week assessment at 6 month follow up
measure: Change in Average Bed/Waketime Variability for the child from baseline to 12 months
timeFrame: 24/7 during each 2 week assessment at 12 month follow up
measure: Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child
timeFrame: 8 minute protocol during rest at Baseline (in clinic)
measure: Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to immediately after the intervention
timeFrame: 8 minute protocol during rest immediately after the intervention (in clinic)
measure: Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 6 months
timeFrame: 8 minute protocol during rest at 6 month follow up (in clinic)
measure: Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 12 months
timeFrame: 8 minute protocol during rest at 12 month follow up (in clinic)
measure: Baseline Average Objective Total Sleep Time for the parent
timeFrame: 24/7 during each 2 week assessment at Baseline
measure: Change in Average Objective Total Sleep Time for the parent from baseline to immediately after the intervention
timeFrame: 24/7 during each 2 week assessment immediately after the intervention
measure: Change in Average Objective Total Sleep Time for the parent from baseline to 6 months
timeFrame: 24/7 during each 2 week assessment at 6 month follow up
measure: Change in Average Objective Total Sleep Time for the parent from baseline to 12 months
timeFrame: 24/7 during each 2 week assessment at 12 month follow up
Secondary outcomes:
measure: Baseline Aberrant Behavior Checklist (ABC) for the child
timeFrame: Baseline
measure: Aberrant Behavior Checklist (ABC) for the child immediately after the intervention
timeFrame: Immediately after the intervention
measure: Aberrant Behavior Checklist (ABC) for the child at 6 months
timeFrame: At 6 month follow up
measure: Aberrant Behavior Checklist (ABC) for the child at 12 months
timeFrame: At 12 month follow up
measure: Baseline Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+)
timeFrame: Baseline
measure: Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) immediately after the intervention
timeFrame: Immediately after the intervention
measure: Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 6 months
timeFrame: At 6 month follow up
measure: Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 12 months
timeFrame: At 12 month follow up
measure: Baseline Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7)
timeFrame: Baseline
measure: Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) immediately after the intervention
timeFrame: Immediately after the intervention
measure: Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 6 months
timeFrame: At 6 month follow up
measure: Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 12 months
timeFrame: At 12 month follow up
measure: Baseline Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child
timeFrame: Baseline
measure: Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child immediately after the intervention
timeFrame: Immediately after the intervention
measure: Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 6 months
timeFrame: At 6 month follow up
measure: Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 12 months
timeFrame: At 12 month follow up
measure: Baseline Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child
timeFrame: Baseline
measure: Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child immediately after the intervention
timeFrame: Immediately after the intervention
measure: Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 6 months
timeFrame: At 6 month follow up
measure: Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 12 months
timeFrame: At 12 month follow up
measure: Baseline Child Quality of Life: PedsQL Child Form for the child
timeFrame: Baseline
measure: Child Quality of Life: PedsQL Child Form for the child immediately after the intervention
timeFrame: Immediately after the intervention
measure: Child Quality of Life: PedsQL Child Form for the child at 6 months
timeFrame: At 6 month follow up
measure: Child Quality of Life: PedsQL Child Form for the child at 12 months
timeFrame: At 12 month follow up
measure: Baseline Child Quality of Life: PedsQL Parent Form for the child
timeFrame: Baseline
measure: Child Quality of Life: PedsQL Parent Form for the child immediately after the intervention
timeFrame: Immediately after the intervention
measure: Child Quality of Life: PedsQL Parent Form for the child at 6 months
timeFrame: At 6 month follow up
measure: Child Quality of Life: PedsQL Parent Form for the child at 12 months
timeFrame: At 12 month follow up
measure: Baseline Average Subjective Sleep Onset Latency for the child
timeFrame: Each morning for 2 weeks at Baseline
measure: Change in Average Subjective Sleep Onset Latency for the child from baseline to immediately after the intervention
timeFrame: Each morning for 2 weeks immediately after the intervention
measure: Change in Average Subjective Sleep Onset Latency for the child from baseline to 6 months
timeFrame: Each morning for 2 weeks at 6 month follow up
measure: Change in Average Subjective Sleep Onset Latency for the child from baseline to 12 months
timeFrame: Each morning for 2 weeks at 12 month follow up
measure: Baseline Average Subjective Total Wake Time for the child
timeFrame: Each morning for 2 weeks at Baseline
measure: Change in Average Subjective Total Wake Time for the child from baseline to immediately after the intervention
timeFrame: Each morning for 2 weeks immediately after the intervention
measure: Change in Average Subjective Total Wake Time for the child from baseline to 6 months
timeFrame: Each morning for 2 weeks at 6 month follow up
measure: Change in Average Subjective Total Wake Time for the child from baseline to 12 months
timeFrame: Each morning for 2 weeks at 12 month follow up
measure: Baseline Average Subjective Total Sleep Time for the child
timeFrame: Each morning for 2 weeks at Baseline
measure: Change in Average Subjective Total Sleep Time for the child from baseline to immediately after the intervention
timeFrame: Each morning for 2 weeks immediately after the intervention
measure: Change in Average Subjective Total Sleep Time for the child from baseline to 6 months
timeFrame: Each morning for 2 weeks at 6 month follow up
measure: Change in Average Subjective Total Sleep Time for the child from baseline to 12 months
timeFrame: Each morning for 2 weeks at 12 month follow up
measure: Baseline Average Subjective Sleep Efficiency for the child
timeFrame: Each morning for 2 weeks at Baseline
measure: Change in Average Subjective Sleep Efficiency for the child from baseline to immediately after the intervention
timeFrame: Each morning for 2 weeks immediately after the intervention
measure: Change in Average Subjective Sleep Efficiency for the child from baseline to 6 months
timeFrame: Each morning for 2 weeks at 6 month follow up
measure: Change in Average Subjective Sleep Efficiency for the child from baseline to 12 months
timeFrame: Each morning for 2 weeks at 12 month follow up
measure: Baseline Average LF/HF ratio for the child
timeFrame: 8 minute protocol during rest at Baseline (in clinic)
measure: Change in Average LF/HF ratio for the child from baseline to immediately after the intervention
timeFrame: 8 minute protocol during rest immediately after the intervention (in clinic)
measure: Change in Average LF/HF ratio for the child from baseline to 6 months
timeFrame: 8 minute protocol during rest at 6 month follow up (in clinic)
measure: Change in Average LF/HF ratio for the child from baseline to 12 months
timeFrame: 8 minute protocol during rest at 12 month follow up (in clinic)
measure: Baseline Average pNN50 (% of N-N intervals > 50 ms) for the child
timeFrame: 8 minute protocol during rest at Baseline (in clinic)
measure: Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to immediately after the intervention
timeFrame: 8 minute protocol during rest immediately after the intervention (in clinic)
measure: Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 6 months
timeFrame: 8 minute protocol during rest at 6 month follow up (in clinic)
measure: Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 12 months
timeFrame: 8 minute protocol during rest at 12 month follow up (in clinic)
measure: Baseline Average LF/HF ratio for the parent
timeFrame: 8 minute protocol during rest at Baseline (in clinic)
measure: Change in Average LF/HF ratio for the parent from baseline to immediately after the intervention
timeFrame: 8 minute protocol during rest immediately after the intervention (in clinic)
measure: Change in Average LF/HF ratio for the parent from baseline to 6 months
timeFrame: 8 minute protocol during rest at 6 month follow up (in clinic)
measure: Change in Average LF/HF ratio for the parent from baseline to 12 months
timeFrame: 8 minute protocol during rest at 12 month follow up (in clinic)
measure: Baseline Average pNN50 (% of N-N intervals > 50 ms) for the parent
timeFrame: 8 minute protocol during rest at Baseline (in clinic)
measure: Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to immediately after the intervention
timeFrame: 8 minute protocol during rest immediately after the intervention (in clinic)
measure: Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 6 months
timeFrame: 8 minute protocol during rest at 6 month follow up (in clinic)
measure: Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 12 months
timeFrame: 8 minute protocol during rest at 12 month follow up (in clinic)
measure: Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent
timeFrame: 8 minute protocol during rest at Baseline (in clinic)
measure: Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to immediately after the intervention
timeFrame: 8 minute protocol during rest immediately after the intervention (in clinic)
measure: Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 6 months
timeFrame: 8 minute protocol during rest at 6 month follow up (in clinic)
measure: Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 12 months
timeFrame: 8 minute protocol during rest at 12 month follow up (in clinic)
measure: Baseline State-Trait Anxiety Inventory (STAI-Y1) for the parent
timeFrame: Baseline
measure: State-Trait Anxiety Inventory (STAI-Y1) for the parent immediately after the intervention
timeFrame: Immediately after the intervention
measure: State-Trait Anxiety Inventory (STAI-Y1) for the parent at 6 months
timeFrame: At 6 month follow up
measure: State-Trait Anxiety Inventory (STAI-Y1) for the parent at 12 months
timeFrame: At 12 month follow up
measure: Baseline Beck Depression Inventory (BDI-II) for the parent
timeFrame: Baseline
measure: Beck Depression Inventory (BDI-II) for the parent immediately after the intervention
timeFrame: Immediately after the intervention
measure: Beck Depression Inventory (BDI-II) for the parent at 6 months
timeFrame: At 6 month follow up
measure: Beck Depression Inventory (BDI-II) for the parent at 12 months
timeFrame: At 12 month follow up
measure: Baseline Fatigue Severity Scale for the parent
timeFrame: Baseline
measure: Fatigue Severity Scale for the parent immediately after the intervention
timeFrame: Immediately after the intervention
measure: Fatigue Severity Scale for the parent at 6 months
timeFrame: At 6 month follow up
measure: Fatigue Severity Scale for the parent at 12 months
timeFrame: At 12 month follow up
measure: Baseline Daily Fatigue for the parent
timeFrame: Baseline
measure: Daily Fatigue for the parent immediately after the intervention
timeFrame: Immediately after the intervention
measure: Daily Fatigue for the parent at 6 months
timeFrame: At 6 month follow up
measure: Daily Fatigue for the parent at 12 months
timeFrame: At 12 month follow up
measure: Baseline Caregiver Strain Index (CSI) for the parent
timeFrame: Baseline
measure: Caregiver Strain Index (CSI) for the parent immediately after the intervention
timeFrame: Immediately after the intervention
measure: Caregiver Strain Index (CSI) for the parent at 6 months
timeFrame: At 6 month follow up
measure: Caregiver Strain Index (CSI) for the parent at 12 months
timeFrame: At 12 month follow up
measure: Baseline Average Subjective Sleep Onset Latency for the parent
timeFrame: Each morning for 2 weeks at Baseline
measure: Change in Average Subjective Sleep Onset Latency for the parent from baseline to immediately after the intervention
timeFrame: Each morning for 2 weeks immediately after the intervention
measure: Change in Average Subjective Sleep Onset Latency for the parent from baseline to 6 months
timeFrame: Each morning for 2 weeks at 6 month follow up
measure: Change in Average Subjective Sleep Onset Latency for the parent from baseline to 12 months
timeFrame: Each morning for 2 weeks at 12 month follow up
measure: Baseline Average Subjective Total Wake Time for the parent
timeFrame: Each morning for 2 weeks at Baseline
measure: Change in Average Subjective Total Wake Time for the parent from baseline to immediately after the intervention
timeFrame: Each morning for 2 weeks immediately after the intervention
measure: Change in Average Subjective Total Wake Time for the parent from baseline to 6 months
timeFrame: Each morning for 2 weeks at 6 month follow up
measure: Change in Average Subjective Total Wake Time for the parent from baseline to 12 months
timeFrame: Each morning for 2 weeks at 12 month follow up
measure: Baseline Average Subjective Total Sleep Time for the parent
timeFrame: Each morning for 2 weeks at Baseline
measure: Change in Average Subjective Total Sleep Time for the parent from baseline to immediately after the intervention
timeFrame: Each morning for 2 weeks immediately after the intervention
measure: Change in Average Subjective Total Sleep Time for the parent from baseline to 6 months
timeFrame: Each morning for 2 weeks at 6 month follow up
measure: Change in Average Subjective Total Sleep Time for the parent from baseline to 12 months
timeFrame: Each morning for 2 weeks at 12 month follow up
measure: Baseline Average Subjective Sleep Efficiency for the parent
timeFrame: Each morning for 2 weeks at Baseline
measure: Change in Average Subjective Sleep Efficiency for the parent from baseline to immediately after the intervention
timeFrame: Each morning for 2 weeks immediately after the intervention
measure: Change in Average Subjective Sleep Efficiency for the parent from baseline to 6 months
timeFrame: Each morning for 2 weeks at 6 month follow up
measure: Change in Average Subjective Sleep Efficiency for the parent from baseline to 12 months
timeFrame: Each morning for 2 weeks at 12 month follow up
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Thompson Center for Autism and Neurodevelopmental Disorders
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Christina S McCrae, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCrae CS, Mazurek MO, Curtis AF, Beversdorf DQ, Deroche CB, Golzy M, Sohl KA, Ner ZH, Davis BE, Stearns MA, Nair N. Protocol for targeting insomnia in school-aged children with autism spectrum disorder without intellectual disability: a randomised control trial. BMJ Open. 2021 Aug 25;11(8):e045944. doi: 10.1136/bmjopen-2020-045944.