Rest, emotion, and arousal in autistic children ages 6–10
Probing the Role of Sensory Regulation in Sleep Health and Emotion Dysregulation for Autistic Youth
This study tests whether a caregiver-delivered "Power Down" bedtime massage can lower bedtime arousal and help sleep and daytime emotion regulation in autistic children ages 6–10 with sensory over-responsivity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 10 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07476937 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll 60 autistic children aged 6–10 and their caregivers to complete questionnaires, one lab visit measuring sensory responsivity to standardized stimuli, and two weeks of home-based actigraphy and daily diaries. In a subset of 30 children with elevated sensory over-responsivity and bedtime resistance, caregivers will be trained in the Power Down protocol (a gentle pressure massage paired with a mindfulness script) and will deliver it nightly for two weeks while both caregiver and child wear actigraphs and complete daily diaries. The open pilot uses a pre-post design with baseline interviews and exit questionnaires and interviews to measure changes in bedtime arousal, sleep patterns, and daytime emotion dysregulation. The broader cross-sectional component aims to link individual sensory responsivity profiles with sleep disturbance and daytime emotion regulation.
Who should consider this trial
Good fit: Ideal candidates are autistic children aged 6–10 with caregiver-reported autism (SCQ > 11), caregiver-reported bedtime resistance and elevated sensory over-responsivity, whose caregivers can participate in nightly bedtimes and travel to the Pittsburgh lab.
Not a fit: Children with diagnosed sleep apnea or narcolepsy, major psychiatric disorders, unstable medication use, current behavioral sleep treatment, or those without sensory over-responsivity are unlikely to benefit from this specific intervention.
Why it matters
Potential benefit: If successful, the Power Down protocol could offer a low-cost, caregiver-delivered way to reduce bedtime arousal and improve sleep and daytime emotion regulation for autistic children.
How similar studies have performed: Small prior studies and clinical reports suggest pressure-based massage and sensory input can reduce arousal in neurodevelopmental conditions, but rigorous evidence for bedtime massage specifically in autistic children's sleep is limited, so this is a relatively novel pilot test.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Youth between the ages of 6 and 10 years old 2. Caregiver-reported autism diagnosis and \>11 on Social Communication Questionnaire 3. Caregiver-reported bedtime resistance (\>12 on Children's Sleep Habits Questionnaire-Autism; Sleep Initiation subscale - 3-point scale, 6 questions) 4. Caregiver willing to participate in all bedtimes during study 5. Stable medication use (e.g., no changes within 2 weeks) Exclusion Criteria: 1. Participants will be excluded if they do not understand English or are unable to travel to the lab (Pittsburgh, PA). 2. Concurrent diagnosis of sleep apnea, narcolepsy, or major psychiatric disorder (e.g., major depression, bipolar). 3. Unstable medication use (dose or timing). 4. Current behavioral treatment for sleep disorder
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Amy G Hartman, PhD — University of Pittsburgh
- Study coordinator: Amy G Hartman, PhD
- Email: agh38@pitt.edu
- Phone: 412-648-7997
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.