Taking people in United StatesNo phase

Testing Sleep Therapy for Insomnia in School-Aged Children With Autism

Tests behavioral sleep therapy for chronic insomnia in children with autism aged 6 to 12.

Key facts

Who runs it: University of Missouri-Columbia
Where: Columbia, United StatesSee the site
Trial code: NCT04545606
Registry title: Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Status: Recruiting
People taking part: 180 people, planned
Started: 15 Sept 2020
Expected to end: Aug 2030
Type of study: Interventional, 3 groups
Treatments tested: In-Person CBT for insomnia in children with autism
Remote CBT for insomnia in children with autism
Remote sleep hygiene and related education (SHARE) for insomnia in children with autism
Record updated: 15 March 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 6 to 12 with autism spectrum disorder and insomnia. A parent or guardian living in the same home must take part too.

Age: 6 to 12 years
Sex: Boys and girls can join.
Disease stage: Child has an autism diagnosis confirmed with standard tests (ADOS and/or ADI-R) and insomnia for 3+ months that affects daytime life. Diaries and actigraphy show more than 30 minutes of trouble falling asleep, staying asleep or waking early on 6+ nights. Verbal IQ of 70 or more.
Earlier treatment: Cannot have had other non-drug treatment for sleep (including CBT) outside this trial. Stimulants, sleep medicines or melatonin in the last 1 month are not allowed, unless on a stable dose for 3+ months.

Main reasons for not taking part

Untreated medical problems, including other sleep disorders, epilepsy or psychotic disorders
Medicines that change sleep, apart from stimulants, sleep medicines or melatonin as described
Taking part in another randomized research project
Unwilling to accept random assignment
Cannot wear a Holter monitor or actigraphy device

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

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

Who cannot take part

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)
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)
10) other conditions adversely affecting trial participation
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
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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 6 and 12 years old?

Where in United States

Thompson Center for Autism and Neurodevelopmental DisordersColumbia, United StatesContact: Nicole TakahashiTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

In-person CBT for insomnia in children with autismTreatment being tested
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.
Remote CBT for insomnia in children with autismTreatment being tested
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.
Remote behavioral SHARE for insomnia in children with autismTreatment being tested
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.
Treatment: Remote sleep hygiene and related education (SHARE) for insomnia in children with autism