Optimizing Attention and Sleep Intervention Study
OASIS
2 other identifiers
interventional
50
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2023
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2022
CompletedFirst Posted
Study publicly available on registry
January 13, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 24, 2025
November 1, 2025
2.5 years
November 24, 2022
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Intervention Acceptability
Therapists and caregiver report of intervention acceptability will be assessed using the 4-item Acceptability of Intervention Measure (AIM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good acceptability.
Post Intervention at approximately 4 months
Intervention Appropriateness
Therapists and caregiver report of intervention appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good appropriateness.
Post Intervention at approximately 4 months
Intervention Feasibility
Therapists and caregiver report of intervention feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good feasibility.
Post Intervention at approximately 4 months
Problematic Sleep
Using the Brief Child Sleep Questionnaire caregivers will report on their perception of child's sleep as problematic, rated 1 (Not at all) to 5 (A serious problem).
Change from baseline up to 8 months
ADHD Symptoms
Using the 18-item ADHD Rating Scale-IV-Preschool Version caregivers will report on the child's ADHD symptoms. Symptoms are rated from 0 (Rarely) to 3 (Very Often).
Change from baseline up to 8 months
Secondary Outcomes (3)
Nighttime Awakenings
Change from baseline up to 8 months
Sleep Latency
Change from baseline up to 8 months
Consistency of Bedtime Routine
Change from baseline up to 8 months
Other Outcomes (2)
Actigraphy
Change from baseline up to 8 months
Sleep Diary
Change from baseline up to 8 months
Study Arms (2)
Brief Parent Behavioral Intervention
ACTIVE COMPARATORA brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.
Sleep-Focused Parent Behavioral Intervention
EXPERIMENTALA modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.
Interventions
PBI administered in pediatric primary care by an embedded therapist.
SF-PBI administered in pediatric primary care by an embedded therapist.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)
- (2) Severe neurodevelopmental disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Children's Community Pediatrics Bass Wolfson, Cranberry
Cranberry Township, Pennsylvania, 16066, United States
Children's Community Pediatrics GIL Murrysville
Monroeville, Pennsylvania, 15146, United States
Children's Community Pediatrics Shenango
New Castle, Pennsylvania, 16101, United States
Children's Community Pediatrics Neshannock
New Castle, Pennsylvania, 16105, United States
Children's Community Pediatrics GIL East Liberty
Pittsburgh, Pennsylvania, 15206, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Children's Community Pediatrics Bass Wolfson, Squirrel Hill
Pittsburgh, Pennsylvania, 15217, United States
Related Publications (2)
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.
PMID: 8847377BACKGROUNDJoseph 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.
PMID: 40001155RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather M Joseph, DO
Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 24, 2022
First Posted
January 13, 2023
Study Start
December 1, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be shared upon publication or 1 year after the grant end date. Data will be available indefinitely.
- Access Criteria
- Any NIMH NDA authorized users may request the data.
Individual participant data collected during the trial will be shared, after deidentification, via the NIMH National Data Archive.