AzTrials
AzTrials

Insomnia ChronicRECHArgeNCT04545606

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

A study testing In-Person CBT for insomnia in children with autism, Remote CBT for insomnia in children with autism and Remote sleep hygiene and related education (SHARE) for insomnia in children with autism in people with Insomnia Chronic and Autism Spectrum Disorder, run by University of Missouri-Columbia at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 4 sessions of behavioral therapy for sleep problems followed by 4 bimonthly booster sessions. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Insomnia Chronic, Autism Spectrum Disorder
What is being tested?
In-Person CBT for insomnia in children with autism, Remote CBT for insomnia in children with autism and Remote sleep hygiene and related education (SHARE) for insomnia in children with autism
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
15 Sep 2020to Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Melanie Stearns, PhD contact

859-327-7762

mastearns@health.missouri.edu

Sydney Shoemaker, MS contact

573-882-5113

sds3mk@health.missouri.edu

United States1 site, 1 recruiting

  • Thompson Center for Autism and Neurodevelopmental Disorders

    Columbia, Missouri, 65201

    Nicole Takahashi, 573-884-1893, TakahashiN@health.missouri.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
In-Person CBT for insomnia in children with autism, Remote CBT for insomnia in children with autism, Remote sleep hygiene and related education (SHARE) for insomnia in children with autism
Keywords
cognitive behavioral therapy, behavioral therapy, children
Medical subject headings
Sleep Initiation and Maintenance Disorders, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-Person CBT for insomnia in children with autismBehavioural

    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

  • Remote CBT for insomnia in children with autismBehavioural

    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

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

    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
Study groups in NCT04545606
Study groupRoleWhat they receive
In-person CBT for insomnia in children with autismExperimentalIn-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.
Receives: Behavioral: In-Person CBT for insomnia in children with autism
Remote CBT for insomnia in children with autismExperimentalRemote/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.
Receives: Behavioral: Remote CBT for insomnia in children with autism
Remote behavioral SHARE for insomnia in children with autismExperimentalRemote/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.
Receives: Behavioral: Remote sleep hygiene and related education (SHARE) for insomnia in children with autism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline Average Objective Sleep Efficiency for the child

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity

    Measured: 24/7 during each 2 week assessment at Baseline

  2. Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity

    Measured: 24/7 during each 2 week assessment immediately after the intervention

  3. Change in Average Objective Sleep Efficiency for the child from baseline to 6 months

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity

    Measured: 24/7 during each 2 week assessment at 6 month follow up

  4. Change in Average Objective Sleep Efficiency for the child from baseline to 12 months

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity

    Measured: 24/7 during each 2 week assessment at 12 month follow up

  5. Baseline Average Bed/Waketime Variability for the child

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report

    Measured: 24/7 during each 2 week assessment at Baseline

  6. Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report

    Measured: 24/7 during each 2 week assessment immediately after the intervention

  7. Change in Average Bed/Waketime Variability for the child from baseline to 6 months

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report

    Measured: 24/7 during each 2 week assessment at 6 month follow up

  8. Change in Average Bed/Waketime Variability for the child from baseline to 12 months

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report

    Measured: 24/7 during each 2 week assessment at 12 month follow up

  9. Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child

    Child arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at Baseline (in clinic)

  10. Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to immediately after the intervention

    Child arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest immediately after the intervention (in clinic)

  11. Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 6 months

    Child arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 6 month follow up (in clinic)

  12. Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 12 months

    Child arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 12 month follow up (in clinic)

  13. Baseline Average Objective Total Sleep Time for the parent

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity

    Measured: 24/7 during each 2 week assessment at Baseline

  14. Change in Average Objective Total Sleep Time for the parent from baseline to immediately after the intervention

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity

    Measured: 24/7 during each 2 week assessment immediately after the intervention

  15. Change in Average Objective Total Sleep Time for the parent from baseline to 6 months

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity

    Measured: 24/7 during each 2 week assessment at 6 month follow up

  16. Change in Average Objective Total Sleep Time for the parent from baseline to 12 months

    Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity

    Measured: 24/7 during each 2 week assessment at 12 month follow up

Secondary outcomes (100)

  1. Baseline Aberrant Behavior Checklist (ABC) for the child

    Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.

    Measured: Baseline

  2. Aberrant Behavior Checklist (ABC) for the child immediately after the intervention

    Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.

    Measured: Immediately after the intervention

  3. Aberrant Behavior Checklist (ABC) for the child at 6 months

    Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.

    Measured: At 6 month follow up

  4. Aberrant Behavior Checklist (ABC) for the child at 12 months

    Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.

    Measured: At 12 month follow up

  5. Baseline Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+)

    Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.

    Measured: Baseline

  6. Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) immediately after the intervention

    Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.

    Measured: Immediately after the intervention

  7. Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 6 months

    Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.

    Measured: At 6 month follow up

  8. Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 12 months

    Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.

    Measured: At 12 month follow up

  9. Baseline Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7)

    Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.

    Measured: Baseline

  10. Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) immediately after the intervention

    Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.

    Measured: Immediately after the intervention

  11. Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 6 months

    Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.

    Measured: At 6 month follow up

  12. Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 12 months

    Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.

    Measured: At 12 month follow up

  13. Baseline Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child

    Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.

    Measured: Baseline

  14. Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child immediately after the intervention

    Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.

    Measured: Immediately after the intervention

  15. Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 6 months

    Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.

    Measured: At 6 month follow up

  16. Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 12 months

    Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.

    Measured: At 12 month follow up

  17. Baseline Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child

    Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.

    Measured: Baseline

  18. Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child immediately after the intervention

    Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.

    Measured: Immediately after the intervention

  19. Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 6 months

    Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.

    Measured: At 6 month follow up

  20. Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 12 months

    Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.

    Measured: At 12 month follow up

  21. Baseline Child Quality of Life: PedsQL Child Form for the child

    Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.

    Measured: Baseline

  22. Child Quality of Life: PedsQL Child Form for the child immediately after the intervention

    Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.

    Measured: Immediately after the intervention

  23. Child Quality of Life: PedsQL Child Form for the child at 6 months

    Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.

    Measured: At 6 month follow up

  24. Child Quality of Life: PedsQL Child Form for the child at 12 months

    Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.

    Measured: At 12 month follow up

  25. Baseline Child Quality of Life: PedsQL Parent Form for the child

    Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.

    Measured: Baseline

  26. Child Quality of Life: PedsQL Parent Form for the child immediately after the intervention

    Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.

    Measured: Immediately after the intervention

  27. Child Quality of Life: PedsQL Parent Form for the child at 6 months

    Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.

    Measured: At 6 month follow up

  28. Child Quality of Life: PedsQL Parent Form for the child at 12 months

    Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.

    Measured: At 12 month follow up

  29. Baseline Average Subjective Sleep Onset Latency for the child

    Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep

    Measured: Each morning for 2 weeks at Baseline

  30. Change in Average Subjective Sleep Onset Latency for the child from baseline to immediately after the intervention

    Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep

    Measured: Each morning for 2 weeks immediately after the intervention

  31. Change in Average Subjective Sleep Onset Latency for the child from baseline to 6 months

    Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep

    Measured: Each morning for 2 weeks at 6 month follow up

  32. Change in Average Subjective Sleep Onset Latency for the child from baseline to 12 months

    Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep

    Measured: Each morning for 2 weeks at 12 month follow up

  33. Baseline Average Subjective Total Wake Time for the child

    Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep

    Measured: Each morning for 2 weeks at Baseline

  34. Change in Average Subjective Total Wake Time for the child from baseline to immediately after the intervention

    Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep

    Measured: Each morning for 2 weeks immediately after the intervention

  35. Change in Average Subjective Total Wake Time for the child from baseline to 6 months

    Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep

    Measured: Each morning for 2 weeks at 6 month follow up

  36. Change in Average Subjective Total Wake Time for the child from baseline to 12 months

    Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep

    Measured: Each morning for 2 weeks at 12 month follow up

  37. Baseline Average Subjective Total Sleep Time for the child

    Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep

    Measured: Each morning for 2 weeks at Baseline

  38. Change in Average Subjective Total Sleep Time for the child from baseline to immediately after the intervention

    Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep

    Measured: Each morning for 2 weeks immediately after the intervention

  39. Change in Average Subjective Total Sleep Time for the child from baseline to 6 months

    Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep

    Measured: Each morning for 2 weeks at 6 month follow up

  40. Change in Average Subjective Total Sleep Time for the child from baseline to 12 months

    Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep

    Measured: Each morning for 2 weeks at 12 month follow up

  41. Baseline Average Subjective Sleep Efficiency for the child

    Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep

    Measured: Each morning for 2 weeks at Baseline

  42. Change in Average Subjective Sleep Efficiency for the child from baseline to immediately after the intervention

    Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep

    Measured: Each morning for 2 weeks immediately after the intervention

  43. Change in Average Subjective Sleep Efficiency for the child from baseline to 6 months

    Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep

    Measured: Each morning for 2 weeks at 6 month follow up

  44. Change in Average Subjective Sleep Efficiency for the child from baseline to 12 months

    Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep

    Measured: Each morning for 2 weeks at 12 month follow up

  45. Baseline Average LF/HF ratio for the child

    An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at Baseline (in clinic)

  46. Change in Average LF/HF ratio for the child from baseline to immediately after the intervention

    An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest immediately after the intervention (in clinic)

  47. Change in Average LF/HF ratio for the child from baseline to 6 months

    An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 6 month follow up (in clinic)

  48. Change in Average LF/HF ratio for the child from baseline to 12 months

    An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 12 month follow up (in clinic)

  49. Baseline Average pNN50 (% of N-N intervals > 50 ms) for the child

    Child arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at Baseline (in clinic)

  50. Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to immediately after the intervention

    Child arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest immediately after the intervention (in clinic)

  51. Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 6 months

    Child arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 6 month follow up (in clinic)

  52. Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 12 months

    Child arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 12 month follow up (in clinic)

  53. Baseline Average LF/HF ratio for the parent

    An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at Baseline (in clinic)

  54. Change in Average LF/HF ratio for the parent from baseline to immediately after the intervention

    An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest immediately after the intervention (in clinic)

  55. Change in Average LF/HF ratio for the parent from baseline to 6 months

    An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 6 month follow up (in clinic)

  56. Change in Average LF/HF ratio for the parent from baseline to 12 months

    An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 12 month follow up (in clinic)

  57. Baseline Average pNN50 (% of N-N intervals > 50 ms) for the parent

    Parent arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at Baseline (in clinic)

  58. Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to immediately after the intervention

    Parent arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest immediately after the intervention (in clinic)

  59. Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 6 months

    Parent arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 6 month follow up (in clinic)

  60. Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 12 months

    Parent arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 12 month follow up (in clinic)

  61. Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent

    Parent arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at Baseline (in clinic)

  62. Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to immediately after the intervention

    Parent arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest immediately after the intervention (in clinic)

  63. Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 6 months

    Parent arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 6 month follow up (in clinic)

  64. Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 12 months

    Parent arousal measured by Holter Monitors, 8 min ECG

    Measured: 8 minute protocol during rest at 12 month follow up (in clinic)

  65. Baseline State-Trait Anxiety Inventory (STAI-Y1) for the parent

    State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.

    Measured: Baseline

  66. State-Trait Anxiety Inventory (STAI-Y1) for the parent immediately after the intervention

    State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.

    Measured: Immediately after the intervention

  67. State-Trait Anxiety Inventory (STAI-Y1) for the parent at 6 months

    State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.

    Measured: At 6 month follow up

  68. State-Trait Anxiety Inventory (STAI-Y1) for the parent at 12 months

    State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.

    Measured: At 12 month follow up

  69. Baseline Beck Depression Inventory (BDI-II) for the parent

    Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.

    Measured: Baseline

  70. Beck Depression Inventory (BDI-II) for the parent immediately after the intervention

    Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.

    Measured: Immediately after the intervention

  71. Beck Depression Inventory (BDI-II) for the parent at 6 months

    Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.

    Measured: At 6 month follow up

  72. Beck Depression Inventory (BDI-II) for the parent at 12 months

    Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.

    Measured: At 12 month follow up

  73. Baseline Fatigue Severity Scale for the parent

    Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.

    Measured: Baseline

  74. Fatigue Severity Scale for the parent immediately after the intervention

    Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.

    Measured: Immediately after the intervention

  75. Fatigue Severity Scale for the parent at 6 months

    Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.

    Measured: At 6 month follow up

  76. Fatigue Severity Scale for the parent at 12 months

    Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.

    Measured: At 12 month follow up

  77. Baseline Daily Fatigue for the parent

    Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.

    Measured: Baseline

  78. Daily Fatigue for the parent immediately after the intervention

    Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.

    Measured: Immediately after the intervention

  79. Daily Fatigue for the parent at 6 months

    Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.

    Measured: At 6 month follow up

  80. Daily Fatigue for the parent at 12 months

    Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.

    Measured: At 12 month follow up

  81. Baseline Caregiver Strain Index (CSI) for the parent

    Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.

    Measured: Baseline

  82. Caregiver Strain Index (CSI) for the parent immediately after the intervention

    Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.

    Measured: Immediately after the intervention

  83. Caregiver Strain Index (CSI) for the parent at 6 months

    Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.

    Measured: At 6 month follow up

  84. Caregiver Strain Index (CSI) for the parent at 12 months

    Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.

    Measured: At 12 month follow up

  85. Baseline Average Subjective Sleep Onset Latency for the parent

    Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep

    Measured: Each morning for 2 weeks at Baseline

  86. Change in Average Subjective Sleep Onset Latency for the parent from baseline to immediately after the intervention

    Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep

    Measured: Each morning for 2 weeks immediately after the intervention

  87. Change in Average Subjective Sleep Onset Latency for the parent from baseline to 6 months

    Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep

    Measured: Each morning for 2 weeks at 6 month follow up

  88. Change in Average Subjective Sleep Onset Latency for the parent from baseline to 12 months

    Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep

    Measured: Each morning for 2 weeks at 12 month follow up

  89. Baseline Average Subjective Total Wake Time for the parent

    Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks at Baseline

  90. Change in Average Subjective Total Wake Time for the parent from baseline to immediately after the intervention

    Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks immediately after the intervention

  91. Change in Average Subjective Total Wake Time for the parent from baseline to 6 months

    Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks at 6 month follow up

  92. Change in Average Subjective Total Wake Time for the parent from baseline to 12 months

    Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks at 12 month follow up

  93. Baseline Average Subjective Total Sleep Time for the parent

    Diary-reported total sleep time filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks at Baseline

  94. Change in Average Subjective Total Sleep Time for the parent from baseline to immediately after the intervention

    Diary-reported total sleep time filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks immediately after the intervention

  95. Change in Average Subjective Total Sleep Time for the parent from baseline to 6 months

    Diary-reported total sleep time filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks at 6 month follow up

  96. Change in Average Subjective Total Sleep Time for the parent from baseline to 12 months

    Diary-reported total sleep time filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks at 12 month follow up

  97. Baseline Average Subjective Sleep Efficiency for the parent

    Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks at Baseline

  98. Change in Average Subjective Sleep Efficiency for the parent from baseline to immediately after the intervention

    Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks immediately after the intervention

  99. Change in Average Subjective Sleep Efficiency for the parent from baseline to 6 months

    Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks at 6 month follow up

  100. Change in Average Subjective Sleep Efficiency for the parent from baseline to 12 months

    Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep

    Measured: Each morning for 2 weeks at 12 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2020
  2. Study start15 Sep 2020
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04545606
Sponsor's protocol ID
2019182
Other IDs
W81XW-H2010399
Acronym
RECHArge
Status last verified
Mar 2024
First submitted
26 Aug 2020
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • McCrae CS, Mazurek MO, Curtis AF, Beversdorf DQ, Deroche CB, Golzy M, Sohl KA, Ner ZH, Davis BE, Stearns MA, Nair N. Protocol for targeting insomnia in school-aged children with autism spectrum disorder without intellectual disability: a randomised control trial. BMJ Open. 2021 Aug 25;11(8):e045944. doi: 10.1136/bmjopen-2020-045944.

    PubMed 34433593

Questions about this trial

What is this clinical trial studying?

A study testing In-Person CBT for insomnia in children with autism, Remote CBT for insomnia in children with autism and Remote sleep hygiene and related education (SHARE) for insomnia in children with autism in people with Insomnia Chronic and Autism Spectrum Disorder, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melanie Stearns, PhD (859-327-7762, mastearns@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Average Objective Sleep Efficiency for the child (time frame: 24/7 during each 2 week assessment at Baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04545606, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.

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