Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Conditions
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Insomnia Chronic, Autism Spectrum Disorder

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-person CBT for insomnia in children with autism<br>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. | Behavioral: In-Person CBT for insomnia in children with autism<br>* 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<br>|
| Experimental: Remote CBT for insomnia in children with autism<br>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. | Behavioral: Remote CBT for insomnia in children with autism<br>* 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<br>|
| Experimental: Remote behavioral SHARE for insomnia in children with autism<br>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. | Behavioral: Remote sleep hygiene and related education (SHARE) for insomnia in children with autism<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioral therapy, behavioral therapy, children