NCT06386029 The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol
| NCT ID | NCT06386029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Autism |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-07-05 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-07-05 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are: 1. Is the Power Down feasible for caregivers to do each night? 2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?
Eligibility Criteria
Inclusion Criteria: 1. Child between the ages of 6 and 10 years old (at least 40%, no more than 60% female) 2. Parent-reported autism diagnosis for child 3. Parent-reported extended and problematic settling down delay 4. Parent-reported sensory over-responsivity (a "yes" to at least 8 items in the sensory screening section of the checklist) 5. Parent willing to participate in nightly routine during the 2 week study 6. Located within the Pittsburgh area Exclusion Criteria: 1. Participants will be excluded if they do not understand English or are unable to travel to University of Pittsburgh Medical Center Western Psychiatric Hospital. 2. Children who have trauma or other histories for whom physical touch is triggering (per caregiver report) will be excluded. 3. If a child spends bedtime at a different caregiver's home for \>50% of the nights and that caregiver is not willing to participate in this study, the child will be excluded from this study.
Contact & Investigator
Amy G Hartman, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06386029 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 10 Years, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06386029 currently recruiting?
Yes, NCT06386029 is actively recruiting participants. Contact the research team at agh38@pitt.edu for enrollment information.
Where is the NCT06386029 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06386029 clinical trial?
NCT06386029 is sponsored by University of Pittsburgh. The principal investigator is Amy G Hartman, PhD at University of Pittsburgh. The trial plans to enroll 10 participants.