Clinical trial Recruiting at 1 site Interventional Ages 6 to 10

Rest, emotion, and arousal in autistic children ages 6–10

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

Run by University of Pittsburgh · NCT07476937 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages6 Years to 10 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity of Pittsburgh
Academic / other
Locations1 site (Pittsburgh, Pennsylvania)
StatusRecruiting
StartedJuly 20, 2026
Main results expectedJuly 2030
Study endsAugust 2030
Registry record updatedJuly 22, 2026
Trial IDNCT07476937 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.