Autism Spectrum Disorder Clinical Trials

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Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
United States
Missouri
Thompson Center for Autism and Neurodevelopmental Disorders
RECRUITING
Columbia
Contact Information
Primary
Melanie Stearns, PhD
mastearns@health.missouri.edu
859-327-7762
Backup
Sydney Shoemaker, MS
sds3mk@health.missouri.edu
573-882-5113
Time Frame
Start Date: 2020-09-15
Estimated Completion Date: 2030-08
Participants
Target number of participants: 180
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: University of Missouri-Columbia

This content was sourced from clinicaltrials.gov