Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Not Applicable

Recruiting

• Conditions: Insomnia Chronic; Autism Spectrum Disorder
• Interventions: Behavioral: In-Person CBT for insomnia in children with autism; Behavioral: Remote CBT for insomnia in children with autism; Behavioral: Remote sleep hygiene and related education (SHARE) for insomnia in children with autism

• Registration Number: NCT04545606
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-11
• Study Start: 2020-09-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-08
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-person CBT for insomnia in children with autism	In-Person CBT for insomnia in children with autism	In-person cognitive-behavioral treatment (CBT) for insomnia in children with autism will be conducted at the Thompson Center. In-person treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep concerns based on the clinical interview.
Remote CBT for insomnia in children with autism	Remote CBT for insomnia in children with autism	Remote/videoconferenced cognitive-behavioral treatment (CBT) for insomnia in children with autism will be conducted from home (families)/Thompson Center (therapist). Remote treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep concerns based on the clinical interview.
Remote behavioral SHARE for insomnia in children with autism	Remote sleep hygiene and related education (SHARE) for insomnia in children with autism	Remote/videoconferenced behavioral sleep hygiene and related education (SHARE) for insomnia in children with autism will be conducted from home (families)/Thompson Center (therapist). Remote treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep and related health related concerns/interests.

Primary Outcome Measures

Name	Time	Method
Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child	8 minute protocol during rest at Baseline (in clinic)	Child arousal measured by Holter Monitors, 8 min ECG
Baseline Average Objective Sleep Efficiency for the child	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	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	8 minute protocol during rest at 6 month follow up (in clinic)	Child arousal measured by Holter Monitors, 8 min ECG
Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention	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	8 minute protocol during rest at 12 month follow up (in clinic)	Child arousal measured by Holter Monitors, 8 min ECG
Baseline Average Bed/Waketime Variability for the child	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	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
Change in Average Objective Total Sleep Time for the parent from baseline to immediately after the intervention	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	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	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	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	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	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	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	24/7 during each 2 week assessment at 12 month follow up	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity

Secondary Outcome Measures

Name	Time	Method
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)	An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
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)	Parent arousal measured by Holter Monitors, 8 min ECG
Baseline Average pNN50 (% of N-N intervals > 50 ms) for the parent	8 minute protocol during rest at Baseline (in clinic)	Parent arousal measured by Holter Monitors, 8 min ECG
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)	Parent arousal measured by Holter Monitors, 8 min ECG
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)	Parent arousal measured by Holter Monitors, 8 min ECG
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	Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Change in Average Subjective Sleep Efficiency for the child from baseline to 6 months	Each morning for 2 weeks at 6 month follow up	Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
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)	Child arousal measured by Holter Monitors, 8 min ECG
Baseline Average LF/HF ratio for the parent	8 minute protocol during rest at Baseline (in clinic)	An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
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)	An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Baseline Aberrant Behavior Checklist (ABC) for the child	Baseline	Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Aberrant Behavior Checklist (ABC) for the child immediately after the intervention	Immediately after the intervention	Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
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) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 12 months	At 12 month follow up	Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) immediately after the intervention	Immediately after the intervention	Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Aberrant Behavior Checklist (ABC) for the child at 6 months	At 6 month follow up	Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Aberrant Behavior Checklist (ABC) for the child at 12 months	At 12 month follow up	Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) immediately after the intervention	Immediately after the intervention	Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Baseline Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7)	Baseline	Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 6 months	At 6 month follow up	Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 12 months	At 12 month follow up	Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child immediately after the intervention	Immediately after the intervention	Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 12 months	At 12 month follow up	Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Child Quality of Life: PedsQL Child Form for the child at 6 months	At 6 month follow up	Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Child Quality of Life: PedsQL Parent Form for the child at 12 months	At 12 month follow up	Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
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	Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Baseline Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+)	Baseline	Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Child Quality of Life: PedsQL Child Form for the child immediately after the intervention	Immediately after the intervention	Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Child Quality of Life: PedsQL Child Form for the child at 12 months	At 12 month follow up	Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Baseline Average Subjective Sleep Onset Latency for the child	Each morning for 2 weeks at Baseline	Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
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	Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
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	Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
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	Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
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	Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
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) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 6 months	At 6 month follow up	Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 6 months	At 6 month follow up	Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Baseline Child Quality of Life: PedsQL Parent Form for the child	Baseline	Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Child Quality of Life: PedsQL Parent Form for the child immediately after the intervention	Immediately after the intervention	Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
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	Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Baseline Average Subjective Total Sleep Time for the child	Each morning for 2 weeks at Baseline	Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
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	Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Baseline Average LF/HF ratio for the child	8 minute protocol during rest at Baseline (in clinic)	An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Baseline Average pNN50 (% of N-N intervals > 50 ms) for the child	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 parent from baseline to 12 months	8 minute protocol during rest at 12 month follow up (in clinic)	Parent arousal measured by Holter Monitors, 8 min ECG
Baseline Child Quality of Life: PedsQL Child Form for the child	Baseline	Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Child Quality of Life: PedsQL Parent Form for the child at 6 months	At 6 month follow up	Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Baseline Average Subjective Total Wake Time for the child	Each morning for 2 weeks at Baseline	Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
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)	An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
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)	An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
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)	Parent arousal measured by Holter Monitors, 8 min ECG
State-Trait Anxiety Inventory (STAI-Y1) for the parent at 12 months	At 12 month follow up	State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale \[1 (not at all) to 4 (very much so)\]. This will be filled out by the parents regarding the parents.
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 12 months	At 12 month follow up	Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
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) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child immediately after the intervention	Immediately after the intervention	Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
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)	Child arousal measured by Holter Monitors, 8 min ECG
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)	Child arousal measured by Holter Monitors, 8 min ECG
Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent	8 minute protocol during rest at Baseline (in clinic)	Parent arousal measured by Holter Monitors, 8 min ECG
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)	Parent arousal measured by Holter Monitors, 8 min ECG
Baseline State-Trait Anxiety Inventory (STAI-Y1) for the parent	Baseline	State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale \[1 (not at all) to 4 (very much so)\]. This will be filled out by the parents regarding the parents.
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	Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
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	Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Baseline Average Subjective Sleep Efficiency for the child	Each morning for 2 weeks at Baseline	Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
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	Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Change in Average Subjective Sleep Efficiency for the child from baseline to 12 months	Each morning for 2 weeks at 12 month follow up	Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
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)	An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
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)	An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Fatigue Severity Scale for the parent at 6 months	At 6 month follow up	Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Daily Fatigue for the parent at 12 months	At 12 month follow up	Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Baseline Average Subjective Total Sleep Time for the parent	Each morning for 2 weeks at Baseline	Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Caregiver Strain Index (CSI) for the parent at 12 months	At 12 month follow up	Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
State-Trait Anxiety Inventory (STAI-Y1) for the parent immediately after the intervention	Immediately after the intervention	State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale \[1 (not at all) to 4 (very much so)\]. This will be filled out by the parents regarding the parents.
State-Trait Anxiety Inventory (STAI-Y1) for the parent at 6 months	At 6 month follow up	State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale \[1 (not at all) to 4 (very much so)\]. This will be filled out by the parents regarding the parents.
Beck Depression Inventory (BDI-II) for the parent immediately after the intervention	Immediately after the intervention	Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Baseline Fatigue Severity Scale for the parent	Baseline	Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Fatigue Severity Scale for the parent at 12 months	At 12 month follow up	Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Daily Fatigue for the parent immediately after the intervention	Immediately after the intervention	Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Daily Fatigue for the parent at 6 months	At 6 month follow up	Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Baseline Caregiver Strain Index (CSI) for the parent	Baseline	Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Caregiver Strain Index (CSI) for the parent immediately after the intervention	Immediately after the intervention	Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Baseline Beck Depression Inventory (BDI-II) for the parent	Baseline	Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Beck Depression Inventory (BDI-II) for the parent at 6 months	At 6 month follow up	Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Fatigue Severity Scale for the parent immediately after the intervention	Immediately after the intervention	Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Baseline Daily Fatigue for the parent	Baseline	Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
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	Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Baseline Average Subjective Total Wake Time for the parent	Each morning for 2 weeks at Baseline	Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
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	Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Baseline Average Subjective Sleep Efficiency for the parent	Each morning for 2 weeks at Baseline	Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Change in Average Subjective Sleep Efficiency for the parent from baseline to 6 months	Each morning for 2 weeks at 6 month follow up	Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Beck Depression Inventory (BDI-II) for the parent at 12 months	At 12 month follow up	Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Caregiver Strain Index (CSI) for the parent at 6 months	At 6 month follow up	Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
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	Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
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	Diary-reported total sleep time filled out by the parent regarding the parent's sleep
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	Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Change in Average Subjective Sleep Efficiency for the parent from baseline to 12 months	Each morning for 2 weeks at 12 month follow up	Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Baseline Average Subjective Sleep Onset Latency for the parent	Each morning for 2 weeks at Baseline	Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
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	Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
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	Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
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	Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
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	Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep

Trial Locations

Locations (1)

Thompson Center for Autism and Neurodevelopmental Disorders; 🇺🇸 Columbia, Missouri, United States