NCT05683756

Optimizing Attention and Sleep Intervention Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-01-13
• Last updated: 2025-11-24

Locations

7 sites across 1 country: United States