NCT05683756 Optimizing Attention and Sleep Intervention Study
| NCT ID | NCT05683756 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Attention Deficit and Disruptive Behavior Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-06 |
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 50 participants in total. It began in 2023-12-01 with a primary completion date of 2026-06.
⚠ 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 clinical effectiveness trial is to compare a brief parent behavioral intervention (PBI) to a modified sleep focused PBI (SF-PBI) delivered by therapists in pediatric primary care for families of children 3-5 years old with sleep problems and early ADHD symptoms. The main aims are to: Aim 1: Demonstrate the acceptability, feasibility, and appropriateness of the sleep focused PBI (SF-PBI) delivered in pediatric primary care for preschool-aged children (3-5 years old) at elevated risk for ADHD. Aim 2: Examine change in target engagement (sleep) and ADHD symptoms among preschool-aged children at elevated risk for ADHD receiving SF-PBI compared to standard PBI.
Eligibility Criteria
Inclusion Criteria: Parent/Caregiver: * (1) Legal guardian is at least 18 years of age * (2) Reads and speaks English Child: * (1) 3-5 years of age * (2) Caregiver report of 4 or more ADHD symptoms * (3) Caregiver reports child's sleep as a "moderate" or "serious problem" * (4) English speaking * (5) Child receives care from participating pediatric primary care office Exclusion Criteria: * (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea) * (2) Severe neurodevelopmental disorder
Contact & Investigator
Heather M Joseph, DO
PRINCIPAL INVESTIGATOR
Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05683756 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 5 Years, studying Attention Deficit and Disruptive Behavior Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05683756 currently recruiting?
Yes, NCT05683756 is actively recruiting participants. Contact the research team at liebherrh@upmc.edu for enrollment information.
Where is the NCT05683756 trial being conducted?
This trial is being conducted at Cranberry Township, United States, Monroeville, United States, New Castle, United States, New Castle, United States and 3 additional locations.
Who is sponsoring the NCT05683756 clinical trial?
NCT05683756 is sponsored by University of Pittsburgh. The principal investigator is Heather M Joseph, DO at Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh. The trial plans to enroll 50 participants.