RecruitingNot ApplicableNCT05683756

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


Sponsor

University of Pittsburgh

Enrollment

50 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 5 Years

Inclusion Criteria9

  • 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 Criteria2

  • (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)
  • (2) Severe neurodevelopmental disorder

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Interventions

BEHAVIORALBrief Parent Behavioral Intervention

PBI administered in pediatric primary care by an embedded therapist.

BEHAVIORALSleep-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

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NCT05683756


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