Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-12-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Brief Parent Behavioral Intervention
A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.
Brief Parent Behavioral Intervention
PBI administered in pediatric primary care by an embedded therapist.
Sleep-Focused Parent Behavioral Intervention
A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.
Sleep-Focused Parent Behavioral Intervention
SF-PBI administered in pediatric primary care by an embedded therapist.
Interventions
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Brief Parent Behavioral Intervention
PBI administered in pediatric primary care by an embedded therapist.
Sleep-Focused Parent Behavioral Intervention
SF-PBI administered in pediatric primary care by an embedded therapist.
Eligibility Criteria
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Inclusion Criteria
* (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
* (2) Severe neurodevelopmental disorder
3 Years
5 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Heather Joseph
Assistant Professor
Principal Investigators
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Heather M Joseph, DO
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh
Locations
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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
Countries
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Central Contacts
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References
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Cunningham CE, Bremner R, Boyle M. Large group community-based parenting programs for families of preschoolers at risk for disruptive behaviour disorders: utilization, cost effectiveness, and outcome. J Child Psychol Psychiatry. 1995 Oct;36(7):1141-59. doi: 10.1111/j.1469-7610.1995.tb01362.x.
Joseph HM, Levenson JC, Conlon RPK, Mannion K, Kipp HL, Gradian A, Wallace ML, Williamson AA. Optimizing Attention and Sleep Intervention Study (OASIS): a protocol for a pilot randomized controlled trial to compare parent behavioral interventions with and without sleep strategies delivered in pediatric primary care for preschool-aged children at risk of childhood ADHD. Pilot Feasibility Stud. 2025 Feb 25;11(1):22. doi: 10.1186/s40814-025-01600-0.
Other Identifiers
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STUDY22070096
Identifier Type: -
Identifier Source: org_study_id
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