Targeting Insomnia in School Aged Children With Autism Spectrum Disorder (RECHArge)

University of Missouri (MU)

Status: Enrolling

Conditions: Autism Spectrum Disorder; Insomnia Chronic

Treatments: Behavioral: Remote CBT for insomnia in children with autism; Behavioral: In-Person CBT for insomnia in children with autism; Behavioral: Remote sleep hygiene and related education (SHARE) for insomnia in children with autism

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04545606

W81XW-H2010399 (Other Grant/Funding Number)

2019182

Details and patient eligibility

About

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.

Full description

Children with autism often have difficulties falling and staying asleep at night. Those sleep difficulties can contribute to daytime problems with irritability, learning, and behavior. Parents are often stressed about their child's sleep difficulties and as a result, their sleep can suffer as well. Treatment that focuses on establishing behaviors and routines that help reduce arousal and support good sleep are helpful for improving the sleep of children without autism, but have not yet been tested in children with autism.

Previous studies have indicated that distance can make it difficult for families to participate in treatment. As such, we will conduct treatment remotely for two of treatment arms. Having remote versions of the treatment can expand the number of children and families that are able to receive these promising treatments. This may be particularly important for children with ASD living in rural and underserved areas as well as those in military families that may not have access to a healthcare provider with training in behavioral sleep treatments.

Enrollment: 180 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion 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

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

In-person CBT for insomnia in children with autism

Experimental group

Description:

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.

Treatment:

Behavioral: In-Person CBT for insomnia in children with autism

Remote CBT for insomnia in children with autism

Experimental group

Description:

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.

Treatment:

Behavioral: Remote CBT for insomnia in children with autism

Remote behavioral SHARE for insomnia in children with autism

Experimental group

Description:

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:

Behavioral: Remote sleep hygiene and related education (SHARE) for insomnia in children with autism