Targeting Insomnia in School Aged Children With Autism Spectrum Disorder (RECHArge)

March 12, 2024 updated by: Christina McCrae, University of Missouri-Columbia
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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Missouri
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • Thompson Center for Autism and Neurodevelopmental Disorders
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
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.

7 modules administered in-person

  1. Sleep Hygiene & Sleep Prescription
  2. Bedtime Routine & Parent Management
  3. Cue Control & Parent Management
  4. Co-Sleeping & Parents Fading out of Room
  5. Circadian Education, Morning Routine, & Relaxation
  6. Cognitive Therapy Basics
  7. Nighttime Fears, Anxiety, & Nightmares
Experimental: 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.

7 modules administered over telehealth/videoconferencing

  1. Sleep Hygiene & Sleep Prescription
  2. Bedtime Routine & Parent Management
  3. Cue Control & Parent Management
  4. Co-Sleeping & Parents Fading out of Room
  5. Circadian Education, Morning Routine, & Relaxation
  6. Cognitive Therapy Basics
  7. Nighttime Fears, Anxiety, & Nightmares
Experimental: Remote behavioral 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.

7 modules administered over telehealth/videoconferencing

  1. Sleep Education
  2. Sleep Architecture & Parasomnias
  3. Physical Activity & Sleep
  4. Nutrition, My Plate, & Breathing during Sleep
  5. Stress, Sleep, Dreams, & Nightmares Connections
  6. Mood, Self-Esteem, & Sleep
  7. Light & Dark Cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Average Objective Sleep Efficiency for the child
Time Frame: 24/7 during each 2 week assessment at Baseline
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
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
Time Frame: 24/7 during each 2 week assessment 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
Time Frame: 24/7 during each 2 week assessment at 6 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
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
Time Frame: 24/7 during each 2 week assessment at 12 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
24/7 during each 2 week assessment at 12 month follow up
Baseline Average Bed/Waketime Variability for the child
Time Frame: 24/7 during each 2 week assessment at Baseline
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
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
Time Frame: 24/7 during each 2 week assessment immediately after the intervention
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
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
Time Frame: 24/7 during each 2 week assessment at 6 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
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
Time Frame: 24/7 during each 2 week assessment at 12 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
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
Time Frame: 8 minute protocol during rest at Baseline (in clinic)
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
Time Frame: 8 minute protocol during rest immediately after the intervention (in clinic)
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
Time Frame: 8 minute protocol during rest at 6 month follow up (in clinic)
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
Time Frame: 8 minute protocol during rest at 12 month follow up (in clinic)
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
Time Frame: 24/7 during each 2 week assessment at Baseline
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
Time Frame: 24/7 during each 2 week assessment 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
Time Frame: 24/7 during each 2 week assessment at 6 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
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
Time Frame: 24/7 during each 2 week assessment at 12 month follow up
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
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
Time Frame: 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.
Baseline
Aberrant Behavior Checklist (ABC) for the child immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Aberrant Behavior Checklist (ABC) for the child at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+)
Time Frame: 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.
Baseline
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7)
Time Frame: 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.
Baseline
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child
Time Frame: 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.
Baseline
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child
Time Frame: 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.
Baseline
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Child Quality of Life: PedsQL Child Form for the child
Time Frame: 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.
Baseline
Child Quality of Life: PedsQL Child Form for the child immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Child Quality of Life: PedsQL Child Form for the child at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Child Quality of Life: PedsQL Parent Form for the child
Time Frame: 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.
Baseline
Child Quality of Life: PedsQL Parent Form for the child immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Child Quality of Life: PedsQL Parent Form for the child at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Average Subjective Sleep Onset Latency for the child
Time Frame: 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
Each morning for 2 weeks at Baseline
Change in Average Subjective Sleep Onset Latency for the child from baseline to immediately after the intervention
Time Frame: 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
Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Sleep Onset Latency for the child from baseline to 6 months
Time Frame: 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
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
Time Frame: 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
Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Total Wake Time for the child
Time Frame: 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
Each morning for 2 weeks at Baseline
Change in Average Subjective Total Wake Time for the child from baseline to immediately after the intervention
Time Frame: 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
Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Total Wake Time for the child from baseline to 6 months
Time Frame: 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
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
Time Frame: 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
Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Total Sleep Time for the child
Time Frame: 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
Each morning for 2 weeks at Baseline
Change in Average Subjective Total Sleep Time for the child from baseline to immediately after the intervention
Time Frame: 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
Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Total Sleep Time for the child from baseline to 6 months
Time Frame: 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
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
Time Frame: 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
Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Sleep Efficiency for the child
Time Frame: 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
Each morning for 2 weeks at Baseline
Change in Average Subjective Sleep Efficiency for the child from baseline to immediately after the intervention
Time Frame: 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
Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Sleep Efficiency for the child from baseline to 6 months
Time Frame: 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
Each morning for 2 weeks at 6 month follow up
Change in Average Subjective Sleep Efficiency for the child from baseline to 12 months
Time Frame: 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
Each morning for 2 weeks at 12 month follow up
Baseline Average LF/HF ratio for the child
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
8 minute protocol during rest at 12 month follow up (in clinic)
Baseline Average pNN50 (% of N-N intervals > 50 ms) for the child
Time Frame: 8 minute protocol during rest at Baseline (in clinic)
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
Time Frame: 8 minute protocol during rest immediately after the intervention (in clinic)
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
Time Frame: 8 minute protocol during rest at 6 month follow up (in clinic)
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
Time Frame: 8 minute protocol during rest at 12 month follow up (in clinic)
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
8 minute protocol during rest at 12 month follow up (in clinic)
Baseline Average pNN50 (% of N-N intervals > 50 ms) for the parent
Time Frame: 8 minute protocol during rest at Baseline (in clinic)
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
Time Frame: 8 minute protocol during rest immediately after the intervention (in clinic)
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
Time Frame: 8 minute protocol during rest at 6 month follow up (in clinic)
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
Time Frame: 8 minute protocol during rest at 12 month follow up (in clinic)
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
Time Frame: 8 minute protocol during rest at Baseline (in clinic)
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
Time Frame: 8 minute protocol during rest immediately after the intervention (in clinic)
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
Time Frame: 8 minute protocol during rest at 6 month follow up (in clinic)
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
Time Frame: 8 minute protocol during rest at 12 month follow up (in clinic)
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
Time Frame: 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.
Baseline
State-Trait Anxiety Inventory (STAI-Y1) for the parent immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
State-Trait Anxiety Inventory (STAI-Y1) for the parent at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Beck Depression Inventory (BDI-II) for the parent
Time Frame: 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.
Baseline
Beck Depression Inventory (BDI-II) for the parent immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Beck Depression Inventory (BDI-II) for the parent at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Fatigue Severity Scale for the parent
Time Frame: 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.
Baseline
Fatigue Severity Scale for the parent immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Fatigue Severity Scale for the parent at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Daily Fatigue for the parent
Time Frame: Baseline
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
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Daily Fatigue for the parent at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Caregiver Strain Index (CSI) for the parent
Time Frame: 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.
Baseline
Caregiver Strain Index (CSI) for the parent immediately after the intervention
Time Frame: 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
Time Frame: 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.
At 6 month follow up
Caregiver Strain Index (CSI) for the parent at 12 months
Time Frame: 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.
At 12 month follow up
Baseline Average Subjective Sleep Onset Latency for the parent
Time Frame: 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
Each morning for 2 weeks at Baseline
Change in Average Subjective Sleep Onset Latency for the parent from baseline to immediately after the intervention
Time Frame: 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
Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Sleep Onset Latency for the parent from baseline to 6 months
Time Frame: 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
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
Time Frame: 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
Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Total Wake Time for the parent
Time Frame: 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
Each morning for 2 weeks at Baseline
Change in Average Subjective Total Wake Time for the parent from baseline to immediately after the intervention
Time Frame: 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
Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Total Wake Time for the parent from baseline to 6 months
Time Frame: 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
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
Time Frame: 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
Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Total Sleep Time for the parent
Time Frame: Each morning for 2 weeks at Baseline
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
Time Frame: Each morning for 2 weeks 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
Time Frame: 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
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
Time Frame: 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
Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Sleep Efficiency for the parent
Time Frame: 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
Each morning for 2 weeks at Baseline
Change in Average Subjective Sleep Efficiency for the parent from baseline to immediately after the intervention
Time Frame: 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
Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Sleep Efficiency for the parent from baseline to 6 months
Time Frame: 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
Each morning for 2 weeks at 6 month follow up
Change in Average Subjective Sleep Efficiency for the parent from baseline to 12 months
Time Frame: 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
Each morning for 2 weeks at 12 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christina S McCrae, PhD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the research team to ensure that it meets reasonable demands of scientific integrity.

IPD Sharing Time Frame

Data will be shared after data collection is complete and results have been published.

IPD Sharing Access Criteria

De-identified data will be made available to other qualified investigators who aim to verify data, conduct meta-analyses, or collaborate with the research team on analyses that are not already planned.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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