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Optimizing Attention and Sleep Intervention Study

NCT05683756 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

  • Attention Deficit and Disruptive Behavior Disorders
  • Attention Deficit Hyperactivity Disorder
  • Child, Preschool
  • Sleep
  • Sleep Disturbance

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Heather M Joseph, DO · Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683756 on ClinicalTrials.gov