Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

NCT04545606 | Recruiting DMC

• 2 other identifiers: 2019182W81XW-H2010399
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic; Autism Spectrum Disorder

Keywords

cognitive behavioral therapy, behavioral therapy; children

Outcome Measures

Primary Outcomes (16)

• Baseline Average Objective Sleep Efficiency for the child

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

  24/7 during each 2 week assessment at Baseline

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

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

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

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

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

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

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

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

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

• Baseline Average Bed/Waketime Variability for the child

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

  24/7 during each 2 week assessment at Baseline

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

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

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

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

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

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

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

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

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

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

  Child arousal measured by Holter Monitors, 8 min ECG

  8 minute protocol during rest at Baseline (in clinic)

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

  Child arousal measured by Holter Monitors, 8 min ECG

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

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

  Child arousal measured by Holter Monitors, 8 min ECG

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

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

  Child arousal measured by Holter Monitors, 8 min ECG

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

• Baseline Average Objective Total Sleep Time for the parent

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

  24/7 during each 2 week assessment at Baseline

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

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

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

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

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

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

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

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

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

Secondary Outcomes (100)

• Baseline Aberrant Behavior Checklist (ABC) for the child

  Baseline

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

  Immediately after the intervention

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

  At 6 month follow up

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

  At 12 month follow up

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

  Baseline

Study Arms (3)

In-person CBT for insomnia in children with autism

EXPERIMENTAL

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

Remote CBT for insomnia in children with autism

EXPERIMENTAL

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

Remote behavioral SHARE for insomnia in children with autism

EXPERIMENTAL

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

Interventions

In-Person CBT for insomnia in children with autism BEHAVIORAL

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

In-person CBT for insomnia in children with autism

Remote CBT for insomnia in children with autism BEHAVIORAL

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 CBT for insomnia in children with autism

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

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

Remote behavioral SHARE for insomnia in children with autism

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) 6-12a yrs
• \) Verbal IQ \>= 70
• \) participation of child's parent or legal guardian living in the same home
• \) parent/guardian ability to read and understand English at the 5th-grade level
• \) child diagnosed with ASD and insomnia
• ASD:
• \) previous DSM diagnosis of ASD
• \) evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised \[ADI-R\])
• Insomnia:
• \) complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
• \) daytime dysfunction (mood, cognitive, social, academic) due to insomnia
• \) 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

You may not qualify if:

• \) parent unable to provide informed consent or child unable to provide assent
• \) unwilling to accept random assignment
• \) participation in another randomized research project
• \) parent unable to complete forms or implement treatment procedures due to cognitive impairment
• \) untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
• \) 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)
• \) stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
• \) participation in non-pharmacological treatment (including CBT) for sleep outside current trial
• \) parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
• \) other conditions adversely affecting trial participation

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• United States Department of Defense: collaborator

Study Sites (1)

Thompson Center for Autism and Neurodevelopmental Disorders

Columbia, Missouri, 65201, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34433593 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Christina S McCrae, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Stearns, PhD

CONTACT

859-327-7762; mastearns@health.missouri.edu

Sydney Shoemaker, MS

CONTACT

573-882-5113; sds3mk@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 11, 2020
• Study Start: September 15, 2020
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2030
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be shared after data collection is complete and results have been published.
• Access Criteria: De-identified data will be made available to other qualified investigators who aim to verify data, conduct meta-analyses, or collaborate with the research team on analyses that are not already planned.

Locations

US (1)