- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545606
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder (RECHArge)
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melanie Stearns, PhD
- Phone Number: 859-327-7762
- Email: mastearns@health.missouri.edu
Study Contact Backup
- Name: Sydney Shoemaker, MS
- Phone Number: 573-882-5113
- Email: sds3mk@health.missouri.edu
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- Recruiting
- Thompson Center for Autism and Neurodevelopmental Disorders
-
Contact:
- Nicole Takahashi
- Phone Number: 573-884-1893
- Email: TakahashiN@health.missouri.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
|
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
|
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
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Christina S McCrae, PhD, University of Missouri-Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019182
- W81XW-H2010399 (Other Grant/Funding Number: Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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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