Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

— RECHArge  

Official title:

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04545606
• Other study ID #: 2019182
• Secondary ID: W81XW-H2010399
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: August 2030

Study information

• Verified date: March 2024
• Source: University of Missouri-Columbia
• Contact: Melanie Stearns, PhD
• Phone: 859-327-7762
• Email: mastearns[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 2030
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• In-Person CBT for insomnia in children with autism
7 modules administered in-person Sleep Hygiene & Sleep Prescription Bedtime Routine & Parent Management Cue Control & Parent Management Co-Sleeping & Parents Fading out of Room Circadian Education, Morning Routine, & Relaxation Cognitive Therapy Basics Nighttime Fears, Anxiety, & Nightmares
• Remote CBT for insomnia in children with autism
7 modules administered over telehealth/videoconferencing Sleep Hygiene & Sleep Prescription Bedtime Routine & Parent Management Cue Control & Parent Management Co-Sleeping & Parents Fading out of Room Circadian Education, Morning Routine, & Relaxation Cognitive Therapy Basics Nighttime Fears, Anxiety, & Nightmares
• Remote sleep hygiene and related education (SHARE) for insomnia in children with autism
7 modules administered over telehealth/videoconferencing Sleep Education Sleep Architecture & Parasomnias Physical Activity & Sleep Nutrition, My Plate, & Breathing during Sleep Stress, Sleep, Dreams, & Nightmares Connections Mood, Self-Esteem, & Sleep Light & Dark Cycle

Locations

Country	Name	City	State
United States	Thompson Center for Autism and Neurodevelopmental Disorders	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Average Objective Sleep Efficiency for the child	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity	24/7 during each 2 week assessment at Baseline
Primary	Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity	24/7 during each 2 week assessment immediately after the intervention
Primary	Change in Average Objective Sleep Efficiency for the child from baseline to 6 months	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity	24/7 during each 2 week assessment at 6 month follow up
Primary	Change in Average Objective Sleep Efficiency for the child from baseline to 12 months	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity	24/7 during each 2 week assessment at 12 month follow up
Primary	Baseline Average Bed/Waketime Variability for the child	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report	24/7 during each 2 week assessment at Baseline
Primary	Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report	24/7 during each 2 week assessment immediately after the intervention
Primary	Change in Average Bed/Waketime Variability for the child from baseline to 6 months	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report	24/7 during each 2 week assessment at 6 month follow up
Primary	Change in Average Bed/Waketime Variability for the child from baseline to 12 months	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report	24/7 during each 2 week assessment at 12 month follow up
Primary	Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child	Child arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at Baseline (in clinic)
Primary	Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to immediately after the intervention	Child arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest immediately after the intervention (in clinic)
Primary	Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 6 months	Child arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 6 month follow up (in clinic)
Primary	Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 12 months	Child arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 12 month follow up (in clinic)
Primary	Baseline Average Objective Total Sleep Time for the parent	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity	24/7 during each 2 week assessment at Baseline
Primary	Change in Average Objective Total Sleep Time for the parent from baseline to immediately after the intervention	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity	24/7 during each 2 week assessment immediately after the intervention
Primary	Change in Average Objective Total Sleep Time for the parent from baseline to 6 months	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity	24/7 during each 2 week assessment at 6 month follow up
Primary	Change in Average Objective Total Sleep Time for the parent from baseline to 12 months	Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity	24/7 during each 2 week assessment at 12 month follow up
Secondary	Baseline Aberrant Behavior Checklist (ABC) for the child	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.	Baseline
Secondary	Aberrant Behavior Checklist (ABC) for the child 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.	Immediately after the intervention
Secondary	Aberrant Behavior Checklist (ABC) for the child at 6 months	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.	At 6 month follow up
Secondary	Aberrant Behavior Checklist (ABC) for the child at 12 months	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.	At 12 month follow up
Secondary	Baseline Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+)	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
Secondary	Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) 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.	Immediately after the intervention
Secondary	Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 6 months	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.	At 6 month follow up
Secondary	Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 12 months	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.	At 12 month follow up
Secondary	Baseline Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7)	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
Secondary	Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) 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.	Immediately after the intervention
Secondary	Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 6 months	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.	At 6 month follow up
Secondary	Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 12 months	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.	At 12 month follow up
Secondary	Baseline Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child	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
Secondary	Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child 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.	Immediately after the intervention
Secondary	Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 6 months	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.	At 6 month follow up
Secondary	Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 12 months	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.	At 12 month follow up
Secondary	Baseline Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child	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
Secondary	Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child 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.	Immediately after the intervention
Secondary	Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 6 months	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.	At 6 month follow up
Secondary	Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 12 months	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.	At 12 month follow up
Secondary	Baseline Child Quality of Life: PedsQL Child Form for the child	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
Secondary	Child Quality of Life: PedsQL Child Form for the child 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.	Immediately after the intervention
Secondary	Child Quality of Life: PedsQL Child Form for the child at 6 months	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.	At 6 month follow up
Secondary	Child Quality of Life: PedsQL Child Form for the child at 12 months	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.	At 12 month follow up
Secondary	Baseline Child Quality of Life: PedsQL Parent Form for the child	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
Secondary	Child Quality of Life: PedsQL Parent Form for the child 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.	Immediately after the intervention
Secondary	Child Quality of Life: PedsQL Parent Form for the child at 6 months	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.	At 6 month follow up
Secondary	Child Quality of Life: PedsQL Parent Form for the child at 12 months	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.	At 12 month follow up
Secondary	Baseline Average Subjective Sleep Onset Latency for the child	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	Each morning for 2 weeks at Baseline
Secondary	Change in Average Subjective Sleep Onset Latency for the child from baseline to 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	Each morning for 2 weeks immediately after the intervention
Secondary	Change in Average Subjective Sleep Onset Latency for the child from baseline to 6 months	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	Each morning for 2 weeks at 6 month follow up
Secondary	Change in Average Subjective Sleep Onset Latency for the child from baseline to 12 months	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	Each morning for 2 weeks at 12 month follow up
Secondary	Baseline Average Subjective Total Wake Time for the child	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	Each morning for 2 weeks at Baseline
Secondary	Change in Average Subjective Total Wake Time for the child from baseline to 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	Each morning for 2 weeks immediately after the intervention
Secondary	Change in Average Subjective Total Wake Time for the child from baseline to 6 months	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	Each morning for 2 weeks at 6 month follow up
Secondary	Change in Average Subjective Total Wake Time for the child from baseline to 12 months	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	Each morning for 2 weeks at 12 month follow up
Secondary	Baseline Average Subjective Total Sleep Time for the child	Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep	Each morning for 2 weeks at Baseline
Secondary	Change in Average Subjective Total Sleep Time for the child from baseline to immediately after the intervention	Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep	Each morning for 2 weeks immediately after the intervention
Secondary	Change in Average Subjective Total Sleep Time for the child from baseline to 6 months	Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep	Each morning for 2 weeks at 6 month follow up
Secondary	Change in Average Subjective Total Sleep Time for the child from baseline to 12 months	Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep	Each morning for 2 weeks at 12 month follow up
Secondary	Baseline Average Subjective Sleep Efficiency for the child	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	Each morning for 2 weeks at Baseline
Secondary	Change in Average Subjective Sleep Efficiency for the child from baseline to 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	Each morning for 2 weeks immediately after the intervention
Secondary	Change in Average Subjective Sleep Efficiency for the child from baseline to 6 months	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	Each morning for 2 weeks at 6 month follow up
Secondary	Change in Average Subjective Sleep Efficiency for the child from baseline to 12 months	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	Each morning for 2 weeks at 12 month follow up
Secondary	Baseline Average LF/HF ratio for the child	An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at Baseline (in clinic)
Secondary	Change in Average LF/HF ratio for the child from baseline to immediately after the intervention	An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG	8 minute protocol during rest immediately after the intervention (in clinic)
Secondary	Change in Average LF/HF ratio for the child from baseline to 6 months	An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 6 month follow up (in clinic)
Secondary	Change in Average LF/HF ratio for the child from baseline to 12 months	An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 12 month follow up (in clinic)
Secondary	Baseline Average pNN50 (% of N-N intervals > 50 ms) for the child	Child arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at Baseline (in clinic)
Secondary	Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to immediately after the intervention	Child arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest immediately after the intervention (in clinic)
Secondary	Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 6 months	Child arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 6 month follow up (in clinic)
Secondary	Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 12 months	Child arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 12 month follow up (in clinic)
Secondary	Baseline Average LF/HF ratio for the parent	An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at Baseline (in clinic)
Secondary	Change in Average LF/HF ratio for the parent from baseline to immediately after the intervention	An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG	8 minute protocol during rest immediately after the intervention (in clinic)
Secondary	Change in Average LF/HF ratio for the parent from baseline to 6 months	An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 6 month follow up (in clinic)
Secondary	Change in Average LF/HF ratio for the parent from baseline to 12 months	An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 12 month follow up (in clinic)
Secondary	Baseline Average pNN50 (% of N-N intervals > 50 ms) for the parent	Parent arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at Baseline (in clinic)
Secondary	Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to immediately after the intervention	Parent arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest immediately after the intervention (in clinic)
Secondary	Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 6 months	Parent arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 6 month follow up (in clinic)
Secondary	Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 12 months	Parent arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 12 month follow up (in clinic)
Secondary	Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent	Parent arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at Baseline (in clinic)
Secondary	Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to immediately after the intervention	Parent arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest immediately after the intervention (in clinic)
Secondary	Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 6 months	Parent arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 6 month follow up (in clinic)
Secondary	Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 12 months	Parent arousal measured by Holter Monitors, 8 min ECG	8 minute protocol during rest at 12 month follow up (in clinic)
Secondary	Baseline State-Trait Anxiety Inventory (STAI-Y1) for the parent	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.	Baseline
Secondary	State-Trait Anxiety Inventory (STAI-Y1) for the parent 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.	Immediately after the intervention
Secondary	State-Trait Anxiety Inventory (STAI-Y1) for the parent at 6 months	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.	At 6 month follow up
Secondary	State-Trait Anxiety Inventory (STAI-Y1) for the parent at 12 months	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.	At 12 month follow up
Secondary	Baseline Beck Depression Inventory (BDI-II) for the parent	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
Secondary	Beck Depression Inventory (BDI-II) for the parent 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.	Immediately after the intervention
Secondary	Beck Depression Inventory (BDI-II) for the parent at 6 months	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.	At 6 month follow up
Secondary	Beck Depression Inventory (BDI-II) for the parent at 12 months	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.	At 12 month follow up
Secondary	Baseline Fatigue Severity Scale for the parent	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
Secondary	Fatigue Severity Scale for the parent 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.	Immediately after the intervention
Secondary	Fatigue Severity Scale for the parent at 6 months	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.	At 6 month follow up
Secondary	Fatigue Severity Scale for the parent at 12 months	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.	At 12 month follow up
Secondary	Baseline Daily Fatigue for the parent	Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.	Baseline
Secondary	Daily Fatigue for the parent 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.	Immediately after the intervention
Secondary	Daily Fatigue for the parent at 6 months	Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.	At 6 month follow up
Secondary	Daily Fatigue for the parent at 12 months	Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.	At 12 month follow up
Secondary	Baseline Caregiver Strain Index (CSI) for the parent	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
Secondary	Caregiver Strain Index (CSI) for the parent 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.	Immediately after the intervention
Secondary	Caregiver Strain Index (CSI) for the parent at 6 months	Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.	At 6 month follow up
Secondary	Caregiver Strain Index (CSI) for the parent at 12 months	Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.	At 12 month follow up
Secondary	Baseline Average Subjective Sleep Onset Latency for the parent	Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep	Each morning for 2 weeks at Baseline
Secondary	Change in Average Subjective Sleep Onset Latency for the parent from baseline to immediately after the intervention	Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep	Each morning for 2 weeks immediately after the intervention
Secondary	Change in Average Subjective Sleep Onset Latency for the parent from baseline to 6 months	Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep	Each morning for 2 weeks at 6 month follow up
Secondary	Change in Average Subjective Sleep Onset Latency for the parent from baseline to 12 months	Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep	Each morning for 2 weeks at 12 month follow up
Secondary	Baseline Average Subjective Total Wake Time for the parent	Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep	Each morning for 2 weeks at Baseline
Secondary	Change in Average Subjective Total Wake Time for the parent from baseline to 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	Each morning for 2 weeks immediately after the intervention
Secondary	Change in Average Subjective Total Wake Time for the parent from baseline to 6 months	Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep	Each morning for 2 weeks at 6 month follow up
Secondary	Change in Average Subjective Total Wake Time for the parent from baseline to 12 months	Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep	Each morning for 2 weeks at 12 month follow up
Secondary	Baseline Average Subjective Total Sleep Time for the parent	Diary-reported total sleep time filled out by the parent regarding the parent's sleep	Each morning for 2 weeks at Baseline
Secondary	Change in Average Subjective Total Sleep Time for the parent from baseline to immediately after the intervention	Diary-reported total sleep time filled out by the parent regarding the parent's sleep	Each morning for 2 weeks immediately after the intervention
Secondary	Change in Average Subjective Total Sleep Time for the parent from baseline to 6 months	Diary-reported total sleep time filled out by the parent regarding the parent's sleep	Each morning for 2 weeks at 6 month follow up
Secondary	Change in Average Subjective Total Sleep Time for the parent from baseline to 12 months	Diary-reported total sleep time filled out by the parent regarding the parent's sleep	Each morning for 2 weeks at 12 month follow up
Secondary	Baseline Average Subjective Sleep Efficiency for the parent	Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep	Each morning for 2 weeks at Baseline
Secondary	Change in Average Subjective Sleep Efficiency for the parent from baseline to immediately after the intervention	Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep	Each morning for 2 weeks immediately after the intervention
Secondary	Change in Average Subjective Sleep Efficiency for the parent from baseline to 6 months	Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep	Each morning for 2 weeks at 6 month follow up
Secondary	Change in Average Subjective Sleep Efficiency for the parent from baseline to 12 months	Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep	Each morning for 2 weeks at 12 month follow up