Optimizing Attention and Sleep Intervention Study

Running, not enrolling · Not applicable

Conditions studied: Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Hyperactivity Disorder, Child, Preschool, Sleep, Sleep Disturbance

In brief

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.

Key facts

Study ID

NCT05683756

Run by

University of Pittsburgh

People needed

50

Starts

2023-12-01

Expected to finish

2026-12-01

Last updated by the study team

2026-06-09

Who can join

Age: 3 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)
• (2) Severe neurodevelopmental disorder

Where it is running

• Children's Community Pediatrics Bass Wolfson, Cranberry — Cranberry Township, Pennsylvania, United States
• Children's Community Pediatrics GIL Murrysville — Monroeville, Pennsylvania, United States
• Children's Community Pediatrics Shenango — New Castle, Pennsylvania, United States
• Children's Community Pediatrics Neshannock — New Castle, Pennsylvania, United States
• Children's Community Pediatrics GIL East Liberty — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Children's Community Pediatrics Bass Wolfson, Squirrel Hill — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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