Actively Recruiting

Phase Not Applicable
Age: 3Years - 5Years
All Genders
NCT05683756

Optimizing Attention and Sleep Intervention Study

Led by University of Pittsburgh · Updated on 2025-11-24

50

Participants Needed

7

Research Sites

156 weeks

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Optimizing Attention and Sleep Intervention Study

Who Can Participate

Age: 3Years - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Legal guardian is at least 18 years of age
  • Parent or caregiver reads and speaks English
  • Child is between 3 and 5 years old
  • Caregiver reports 4 or more ADHD symptoms in the child
  • Caregiver considers the child's sleep a moderate or serious problem
  • Child speaks English
  • Child receives care from a participating pediatric primary care office
Not Eligible

You will not qualify if you...

  • Child has a sleep interfering medical diagnosis such as narcolepsy or obstructive sleep apnea
  • Child has a severe neurodevelopmental disorder

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Children's Community Pediatrics Bass Wolfson, Cranberry

Cranberry Township, Pennsylvania, United States, 16066

Actively Recruiting

2

Children's Community Pediatrics GIL Murrysville

Monroeville, Pennsylvania, United States, 15146

Actively Recruiting

3

Children's Community Pediatrics Shenango

New Castle, Pennsylvania, United States, 16101

Actively Recruiting

4

Children's Community Pediatrics Neshannock

New Castle, Pennsylvania, United States, 16105

Not Yet Recruiting

5

Children's Community Pediatrics GIL East Liberty

Pittsburgh, Pennsylvania, United States, 15206

Actively Recruiting

6

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

7

Children's Community Pediatrics Bass Wolfson, Squirrel Hill

Pittsburgh, Pennsylvania, United States, 15217

Actively Recruiting

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Research Team

H

Heather M Joseph, DO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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