Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2030-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Targeting Sleep in Kids With Autism Spectrum Disorder

NCT02755051

Autism Spectrum Disorder Chronic Insomnia

COMPLETED NA

Cognitive Behaviour Therapy for Sleep Problems in Children With Autism Spectrum Disorder

NCT04319640

Autism Spectrum Disorder Cognitive Behaviour Therapy

UNKNOWN NA

Community-Engaged Sleep Intervention for School-Aged Children With Autism Spectrum Disorder

NCT07007819

Sleep Disturbance Autism Spectrum Disorder

ENROLLING_BY_INVITATION NA

Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder

NCT03668873

Autism Spectrum Disorder Sleep Disturbance

COMPLETED NA

A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

NCT04539990

Autism Autism Spectrum Disorder Sleep

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insomnia Chronic Autism Spectrum Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

In-Person CBT for insomnia in children with autism

Intervention Type BEHAVIORAL

7 modules administered in-person

1. Sleep Hygiene \& Sleep Prescription
2. Bedtime Routine \& Parent Management
3. Cue Control \& Parent Management
4. Co-Sleeping \& Parents Fading out of Room
5. Circadian Education, Morning Routine, \& Relaxation
6. Cognitive Therapy Basics
7. Nighttime Fears, Anxiety, \& Nightmares

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.

Group Type EXPERIMENTAL

Remote CBT for insomnia in children with autism

Intervention Type BEHAVIORAL

7 modules administered over telehealth/videoconferencing

1. Sleep Hygiene \& Sleep Prescription
2. Bedtime Routine \& Parent Management
3. Cue Control \& Parent Management
4. Co-Sleeping \& Parents Fading out of Room
5. Circadian Education, Morning Routine, \& Relaxation
6. Cognitive Therapy Basics
7. Nighttime Fears, Anxiety, \& Nightmares

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

7 modules administered over telehealth/videoconferencing

1. Sleep Education
2. Sleep Architecture \& Parasomnias
3. Physical Activity \& Sleep
4. Nutrition, My Plate, \& Breathing during Sleep
5. Stress, Sleep, Dreams, \& Nightmares Connections
6. Mood, Self-Esteem, \& Sleep
7. Light \& Dark Cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

In-Person CBT for insomnia in children with autism

7 modules administered in-person

1. Sleep Hygiene \& Sleep Prescription
2. Bedtime Routine \& Parent Management
3. Cue Control \& Parent Management
4. Co-Sleeping \& Parents Fading out of Room
5. Circadian Education, Morning Routine, \& Relaxation
6. Cognitive Therapy Basics
7. Nighttime Fears, Anxiety, \& Nightmares

Intervention Type BEHAVIORAL

Remote CBT for insomnia in children with autism

7 modules administered over telehealth/videoconferencing

1. Sleep Hygiene \& Sleep Prescription
2. Bedtime Routine \& Parent Management
3. Cue Control \& Parent Management
4. Co-Sleeping \& Parents Fading out of Room
5. Circadian Education, Morning Routine, \& Relaxation
6. Cognitive Therapy Basics
7. Nighttime Fears, Anxiety, \& Nightmares

Intervention Type BEHAVIORAL

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

7 modules administered over telehealth/videoconferencing

1. Sleep Education
2. Sleep Architecture \& Parasomnias
3. Physical Activity \& Sleep
4. Nutrition, My Plate, \& Breathing during Sleep
5. Stress, Sleep, Dreams, \& Nightmares Connections
6. Mood, Self-Esteem, \& Sleep
7. Light \& Dark Cycle

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No