RECRUITING

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Description

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.

Study Overview

Study Details

Study overview

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.

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Condition
Insomnia Chronic
Intervention / Treatment

-

Contacts and Locations

Columbia

Thompson Center for Autism and Neurodevelopmental Disorders, Columbia, Missouri, United States, 65201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 \[ADI-R\])
  • * 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
  • * 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

Ages Eligible for Study

6 Years to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Missouri-Columbia,

Christina S McCrae, PhD, PRINCIPAL_INVESTIGATOR, University of Missouri-Columbia

Study Record Dates

2030-08