Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Baseline Average Objective Sleep Efficiency for the child [Срок оценки: 24/7 during each 2 week assessment at Baseline]
• Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention [Срок оценки: 24/7 during each 2 week assessment immediately after the intervention]
• Change in Average Objective Sleep Efficiency for the child from baseline to 6 months [Срок оценки: 24/7 during each 2 week assessment at 6 month follow up]
• Change in Average Objective Sleep Efficiency for the child from baseline to 12 months [Срок оценки: 24/7 during each 2 week assessment at 12 month follow up]
• Baseline Average Bed/Waketime Variability for the child [Срок оценки: 24/7 during each 2 week assessment at Baseline]
• Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention [Срок оценки: 24/7 during each 2 week assessment immediately after the intervention]
• Change in Average Bed/Waketime Variability for the child from baseline to 6 months [Срок оценки: 24/7 during each 2 week assessment at 6 month follow up]
• Change in Average Bed/Waketime Variability for the child from baseline to 12 months [Срок оценки: 24/7 during each 2 week assessment at 12 month follow up]
• Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child [Срок оценки: 8 minute protocol during rest at Baseline (in clinic)]
• Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to immediately after the intervention [Срок оценки: 8 minute protocol during rest immediately after the intervention (in clinic)]

Вторичные конечные точки (12)

• Baseline Aberrant Behavior Checklist (ABC) for the child [Срок оценки: Baseline]
• Aberrant Behavior Checklist (ABC) for the child immediately after the intervention [Срок оценки: Immediately after the intervention]
• Aberrant Behavior Checklist (ABC) for the child at 6 months [Срок оценки: At 6 month follow up]
• Aberrant Behavior Checklist (ABC) for the child at 12 months [Срок оценки: At 12 month follow up]
• Baseline Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) [Срок оценки: Baseline]
• Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) immediately after the intervention [Срок оценки: Immediately after the intervention]
• Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 6 months [Срок оценки: At 6 month follow up]
• Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 12 months [Срок оценки: At 12 month follow up]
• Baseline Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) [Срок оценки: Baseline]
• Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) immediately after the intervention [Срок оценки: Immediately after the intervention]
• Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 6 months [Срок оценки: At 6 month follow up]
• Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 12 months [Срок оценки: At 12 month follow up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Thompson Center for Autism and Neurodevelopmental Disorders — Columbia

Публикации

• McCrae CS, Mazurek MO, Curtis AF, Beversdorf DQ, Deroche CB, Golzy M, Sohl KA, Ner ZH, Davis BE, Stearns MA, Nair N. Protocol for targeting insomnia in school-aged children with autism spectrum disorder without intellectual disability: a randomised control trial. BMJ Open. 2021 Aug 25;11(8):e045944. doi: 10.1136/bmjopen-2020-045944. PMID 34433593

Идентификаторы

NCT: NCT04545606 · 2019182 · W81XW-H2010399

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗