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Recruiting NCT05683756

Optimizing Attention and Sleep Intervention Study

Trial Parameters

Condition Attention Deficit and Disruptive Behavior Disorders
Sponsor University of Pittsburgh
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 3 Years
Max Age 5 Years
Start Date 2023-12-01
Completion 2026-06
Interventions
Brief Parent Behavioral InterventionSleep-Focused Parent Behavioral Intervention

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

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