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RECRUITING
NCT05683756
NA

Optimizing Attention and Sleep Intervention Study

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

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.

Official title: Optimizing Attention and Sleep Intervention Study: A Pilot RCT to Compare Parent Behavioral Interventions With and Without Sleep Strategies Delivered in Pediatric Primary Care for Preschool-aged Children at Risk of Childhood ADHD

Key Details

Gender

All

Age Range

3 Years - 5 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-12-01

Completion Date

2026-12

Last Updated

2025-11-24

Healthy Volunteers

No

Interventions

BEHAVIORAL

Brief Parent Behavioral Intervention

PBI administered in pediatric primary care by an embedded therapist.

BEHAVIORAL

Sleep-Focused Parent Behavioral Intervention

SF-PBI administered in pediatric primary care by an embedded therapist.

Locations (7)

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