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Targeting Insomnia in School-Aged Children with Autism Spectrum Disorder

This study is looking at ways to help children aged 6-12 with Autism Spectrum Disorder (ASD) who also have trouble sleeping (insomnia). It tests three different behavioral therapies: in-person Cognitive Behavioral Therapy for insomnia (CBT-I), remote CBT-I (done through video calls), and remote sleep hygiene and related education (SHARE). The goal is to see which approach best improves sleep efficiency (how well a child sleeps once they are in bed). To join, your child must have an ASD diagnosis and insomnia, and you, as their parent or guardian, must live with them and be able to read English at a 5th-grade level. The study aims to enroll 180 children and their families. The current status of the study is unclear.

Study design
This interventional study will randomly assign children and their families to one of three treatment groups: in-person CBT-I, remote CBT-I, or remote SHARE. It plans to enroll 180 participants.
What's involved
Children and their parents will undergo 4 sessions of behavioral therapy, followed by 4 booster sessions every two months. Sleep and other information will be collected at the start, immediately after treatment, and at 6 and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the initial treatment to track changes in sleep and other outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04545606

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Recruiting
NAAges 6–12InterventionalTreatment
University of Missouri-Columbia
~180 participants
Updated 2024-03-15 on ClinicalTrials.gov
What's tested:In-Person CBT for insomnia in children with autismRemote CBT for insomnia in children with autismRemote sleep hygiene and related education (SHARE) for insomnia in children with autism

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Baseline Average Objective Sleep Efficiency for the child
Measured over 24/7 during each 2 week assessment at Baseline
+15 more outcomes measured

Conditions

Insomnia Chronic
Autism Spectrum Disorder

Explore related trials

Autism Spectrum DisorderInsomnia

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

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

Who to contact

Melanie Stearns, PhD
[email protected]
859-327-7762
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Baseline Average Objective Sleep Efficiency for the child24/7 during each 2 week assessment at Baseline

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

  • Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention24/7 during each 2 week assessment immediately after the intervention

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

  • Change in Average Objective Sleep Efficiency for the child from baseline to 6 months24/7 during each 2 week assessment at 6 month follow up

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

  • Change in Average Objective Sleep Efficiency for the child from baseline to 12 months24/7 during each 2 week assessment at 12 month follow up

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

  • Baseline Average Bed/Waketime Variability for the child24/7 during each 2 week assessment at Baseline

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

  • Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention24/7 during each 2 week assessment immediately after the intervention

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

  • Change in Average Bed/Waketime Variability for the child from baseline to 6 months24/7 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

  • Change in Average Bed/Waketime Variability for the child from baseline to 12 months24/7 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

  • Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child8 minute protocol during rest at Baseline (in clinic)

    Child arousal measured by Holter Monitors, 8 min ECG

  • Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to immediately after the intervention8 minute protocol during rest immediately after the intervention (in clinic)

    Child arousal measured by Holter Monitors, 8 min ECG

  • Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 6 months8 minute protocol during rest at 6 month follow up (in clinic)

    Child arousal measured by Holter Monitors, 8 min ECG

  • Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 12 months8 minute protocol during rest at 12 month follow up (in clinic)

    Child arousal measured by Holter Monitors, 8 min ECG

  • Baseline Average Objective Total Sleep Time for the parent24/7 during each 2 week assessment at Baseline

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

  • Change in Average Objective Total Sleep Time for the parent from baseline to immediately after the intervention24/7 during each 2 week assessment immediately after the intervention

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

  • Change in Average Objective Total Sleep Time for the parent from baseline to 6 months24/7 during each 2 week assessment at 6 month follow up

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

  • Change in Average Objective Total Sleep Time for the parent from baseline to 12 months24/7 during each 2 week assessment at 12 month follow up

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