Differences in Rest, Emotion, and Arousal Modulation in Youth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Power Down bedtime manipulation.
- Who it may be relevant to
- Registry conditions: Autism, Sleep Disturbances in Children, Sleep. Basic parameters: 6 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Probing the Role of Sensory Regulation in Sleep Health and Emotion Dysregulation for Autistic Youth
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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
Primary outcome measures
- Nightly emotion dysregulation [Time frame: 4 weeks]
- Bedtime sensory over-responsivity [Time frame: 4 weeks]
- Sleep onset latency [Time frame: 4 weeks]
Secondary outcome measures (4)
- Sleep efficiency [Time frame: 4 weeks]
- Sleep fragmentation index [Time frame: 4 weeks]
- Sensory Processing [Time frame: 4 weeks]
- Emotion Dysregulation Inventory [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT07476937 · STUDY25070165 · K23HD119249