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Optimizing Attention and Sleep Intervention Study

Optimizing Attention and Sleep Intervention Study

Recruiting
3-5 years
All
Phase N/A

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Overview

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.

Description

Sleep problems may be one mechanism through which young children may be at risk for developing ADHD, although first line ADHD interventions, including parent behavioral interventions (PBIs), do not address sleep. Investigators will test a modified version of a PBI to target sleep disrupting behaviors for children 3-5 years old at elevated risk for ADHD. The intervention will be delivered by behavioral health therapists embedded in pediatric primary care to increase families' access to intervention. This pilot effectiveness trial is the first step towards developing an early intervention targeting sleep as a mechanism to reduce the prevalence, symptoms, and impairments associated with childhood ADHD.

Eligibility

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

Study details
    Attention Deficit and Disruptive Behavior Disorders
    Attention Deficit Hyperactivity Disorder
    Child
    Preschool
    Sleep
    Sleep Disturbance

NCT05683756

University of Pittsburgh

13 May 2026

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