RECRUITING

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Conditions

Insomnia Chronic Autism Spectrum Disorder cognitive behavioral therapy, behavioral therapy children

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Quick Facts

Study Start:2020-09-15

Study Completion:2030-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04545606

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.

Ages Eligible for Study:6 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Melanie Stearns, PhD

CONTACT

859-327-7762

mastearns@health.missouri.edu

Sydney Shoemaker, MS

CONTACT

573-882-5113

sds3mk@health.missouri.edu

Principal Investigator

Christina S McCrae, PhD

PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Study Locations (Sites)

Thompson Center for Autism and Neurodevelopmental Disorders

Columbia, Missouri, 65201

United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-15

Study Completion Date2030-08

Study Record Updates

Study Start Date2020-09-15

Study Completion Date2030-08

Terms related to this study

Keywords Provided by Researchers

cognitive behavioral therapy, behavioral therapy
children

Additional Relevant MeSH Terms

Insomnia Chronic
Autism Spectrum Disorder