Differences in Rest, Emotion, and Arousal Modulation in Youth

Официальное название

Probing the Role of Sensory Regulation in Sleep Health and Emotion Dysregulation for Autistic Youth

Обзор

The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.

Подробное описание

This study is a cross-sectional study with a pilot pre-post intervention trial with a subset of participants. A total of 60 autistic children and caregivers will be recruited to complete questionnaires, one lab visit during which sensory responsivity to standardized sensory stimuli will be measured, and two weeks home-based data collection using daily diaries and actigraphy devices (both caregiver and child).

In a subset of 30 participants with elevated sensory over-responsivity and bedtime resistance, participants will be invited to complete the second part of the study- a open pilot study. These participants will complete a baseline interview and a lab-based training session to learn the caregiver-mediated Power Down protocol. The Power Down protocol is a standardized gentle pressure massage with a mindfulness script that aims to decrease autonomic arousal through proprioception and tactile input. Caregivers will complete the Power Down and a home-based data collection protocol for 2 weeks. During this time, caregivers and child will also wear actigraphy devices and complete daily diaries. Upon completion of the study, participants will complete exit questionnaires and an exit interview.

Вмешательства

• Поведенческое Power Down bedtime manipulation
  The Power Down is a bedtime manipulation protocol targeting elevated arousal level at bedtime due to a hypothesized effect of sensory over-responsivity (a common experience for autistic children). The Power Down incorporates sensory-based input (caregiver massage) to support nervous system regulation prior to attempting sleep onset. Participants (caregivers and their child) will be educated in the Power Down protocol and data collection methods for the 2 week intervention trial. Caregivers will

Первичные конечные точки

• Nightly emotion dysregulation [Срок оценки: 4 weeks]
• Bedtime sensory over-responsivity [Срок оценки: 4 weeks]
• Sleep onset latency [Срок оценки: 4 weeks]

Вторичные конечные точки (4)

• Sleep efficiency [Срок оценки: 4 weeks]
• Sleep fragmentation index [Срок оценки: 4 weeks]
• Sensory Processing [Срок оценки: 4 weeks]
• Emotion Dysregulation Inventory [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Youth between the ages of 6 and 10 years old
• Caregiver-reported autism diagnosis and >11 on Social Communication Questionnaire
• Caregiver-reported bedtime resistance (>12 on Children's Sleep Habits Questionnaire-Autism; Sleep Initiation subscale - 3-point scale, 6 questions)
• Caregiver willing to participate in all bedtimes during study
• Stable medication use (e.g., no changes within 2 weeks)

Критерии исключения

• Participants will be excluded if they do not understand English or are unable to travel to the lab (Pittsburgh, PA).
• Concurrent diagnosis of sleep apnea, narcolepsy, or major psychiatric disorder (e.g., major depression, bipolar).
• Unstable medication use (dose or timing).
• Current behavioral treatment for sleep disorder

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT07476937 · STUDY25070165 · K23HD119249

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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