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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545606
Recruitment Status : Recruiting
First Posted : September 11, 2020
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Christina McCrae, University of Missouri-Columbia

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Insomnia Chronic Autism Spectrum Disorder Behavioral: In-Person CBT for insomnia in children with autism Behavioral: Remote CBT for insomnia in children with autism Behavioral: Remote sleep hygiene and related education (SHARE) for insomnia in children with autism Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: In-person CBT for insomnia in children with autism
In-person cognitive-behavioral treatment (CBT) for insomnia in children with autism will be conducted at the Thompson Center. In-person treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep concerns based on the clinical interview.
Behavioral: In-Person CBT for insomnia in children with autism

7 modules administered in-person

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

Experimental: Remote CBT for insomnia in children with autism
Remote/videoconferenced cognitive-behavioral treatment (CBT) for insomnia in children with autism will be conducted from home (families)/Thompson Center (therapist). Remote treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep concerns based on the clinical interview.
Behavioral: Remote CBT for insomnia in children with autism

7 modules administered over telehealth/videoconferencing

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

Experimental: Remote behavioral SHARE for insomnia in children with autism
Remote/videoconferenced behavioral sleep hygiene and related education (SHARE) for insomnia in children with autism will be conducted from home (families)/Thompson Center (therapist). Remote treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep and related health related concerns/interests.
Behavioral: Remote sleep hygiene and related education (SHARE) for insomnia in children with autism

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




Primary Outcome Measures :
  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 (at home) ]
    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 (at home) ]
    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 (at home) ]
    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(at home) ]
    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 Outcome Measures :
  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 (at home) ]
    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 (at home) ]
    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 (at home) ]
    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(at home) ]
    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 (at home) ]
    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 (at home) ]
    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 (at home) ]
    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(at home) ]
    Child arousal measured by Holter Monitors, 8 min ECG

  53. 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.

  54. 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.

  55. 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.

  56. 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.

  57. 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.

  58. 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.

  59. 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.

  60. 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.

  61. 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.

  62. 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.

  63. 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.

  64. 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.

  65. 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.

  66. 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.

  67. 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.

  68. 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.

  69. 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.

  70. 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.

  71. 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.

  72. 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.

  73. 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

  74. 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

  75. 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

  76. 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

  77. 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

  78. 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

  79. 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

  80. 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

  81. 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

  82. 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

  83. 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

  84. 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

  85. 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

  86. 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

  87. 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

  88. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545606


Contacts
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Contact: Melanie Stearns, PhD 859-327-7762 mastearns@health.missouri.edu
Contact: Riley Stephens 573-882-8881 rstephens@health.missouri.edu

Locations
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United States, Missouri
Thompson Center for Autism and Neurodevelopmental Disorders Recruiting
Columbia, Missouri, United States, 65201
Contact: Nicole Takahashi    573-884-1893    TakahashiN@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
United States Department of Defense
Investigators
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Principal Investigator: Christina S McCrae, PhD University of Missouri-Columbia
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Responsible Party: Christina McCrae, Professor, Psychiatry, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04545606    
Other Study ID Numbers: 2019182
W81XW-H2010399 ( Other Grant/Funding Number: Department of Defense )
First Posted: September 11, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina McCrae, University of Missouri-Columbia:
cognitive behavioral therapy, behavioral therapy
children
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases