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NCT Number: NCT04545606

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

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.

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Key information

Conditions

Insomnia Chronic Autism Spectrum Disorder Child Development Disorders, Pervasive Dyssomnias Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thompson Center for Autism and Neurodevelopmental Disorders

Columbia, Missouri, 65201, United States

Location status: Recruiting

Location contact

Nicole Takahashi

CONTACT

[email protected]

573-884-1893

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-Person CBT for insomnia in children with autism

Behavioral

7 modules administered in-person

  • Sleep Hygiene & Sleep Prescription
  • Bedtime Routine & Parent Management
  • Cue Control & Parent Management
  • Co-Sleeping & Parents Fading out of Room
  • Circadian Education, Morning Routine, & Relaxation
  • Cognitive Therapy Basics
  • Nighttime Fears, Anxiety, & Nightmares

Remote CBT for insomnia in children with autism

Behavioral

7 modules administered over telehealth/videoconferencing

  • Sleep Hygiene & Sleep Prescription
  • Bedtime Routine & Parent Management
  • Cue Control & Parent Management
  • Co-Sleeping & Parents Fading out of Room
  • Circadian Education, Morning Routine, & Relaxation
  • Cognitive Therapy Basics
  • Nighttime Fears, Anxiety, & Nightmares

Remote sleep hygiene and related education (SHARE) for insomnia in children with autism

Behavioral

7 modules administered over telehealth/videoconferencing

  • Sleep Education
  • Sleep Architecture & Parasomnias
  • Physical Activity & Sleep
  • Nutrition, My Plate, & Breathing during Sleep
  • Stress, Sleep, Dreams, & Nightmares Connections
  • Mood, Self-Esteem, & Sleep
  • Light & Dark Cycle

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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

  63. 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

  64. 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

  65. 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.

  66. 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.

  67. 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.

  68. 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.

  69. 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.

  70. 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.

  71. 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.

  72. 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.

  73. 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.

  74. 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.

  75. 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.

  76. 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.

  77. 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.

  78. 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.

  79. 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.

  80. 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.

  81. 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.

  82. 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.

  83. 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.

  84. 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.

  85. 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

  86. 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

  87. 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

  88. 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

  89. 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

  90. 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

  91. 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

  92. 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

  93. 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

  94. 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

  95. 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

  96. 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

  97. 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

  98. 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

  99. 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

  100. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Stearns, PhD

CONTACT

[email protected]

859-327-7762

Sydney Shoemaker, MS

CONTACT

[email protected]

573-882-5113

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • United States Department of Defense

Registry information

Acronym: RECHArge

Important dates

Study start
2020
Primary completion
2025
Study completion
2030
First posted
Sep 11, 2020
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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