Large group community-based parenting programs for families of preschoolers at risk for disruptive behaviour disorders: utilization, cost effectiveness, and outcome.
C E Cunningham, R Bremner, M Boyle
https://pubmed.ncbi.nlm.nih.gov/8847377Actively Recruiting
Phase Not Applicable
Age: 3Years - 5Years
All Genders
ID05683756
Optimizing Attention and Sleep Intervention Study: Comparing Parent Behavioral Interventions With and Without Sleep Strategies in Pediatric Primary Care for Preschool Children at Risk of ADHD
Led by University of Pittsburgh · Updated on 2025-11-24
50
Participants Needed
7
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two types of parent behavioral interventions (PBIs) to help preschool-aged children, 3 to 5 years old, who have sleep problems and early signs of ADHD. The study aims to compare a standard brief PBI to a modified version that focuses specifically on sleep-related behaviors. This pilot trial is conducted to see if the sleep-focused intervention is acceptable, feasible, and appropriate when delivered in pediatric primary care, and to examine its impact on children's sleep and ADHD symptoms. The study involves two groups: one receives the standard brief parent behavioral intervention, and the other gets the sleep-focused version of this intervention. Both are delivered by therapists embedded in pediatric primary care settings. The interventions are designed to be brief and accessible to families, with the sleep-focused PBI targeting behaviors that disrupt sleep. The trial runs over several months, with assessments occurring approximately 4 months after intervention and follow-up up to 8 months. Participants will be involved in regular evaluations that track the acceptability, feasibility, and appropriateness of the interventions. Researchers will measure changes in problematic sleep and ADHD symptoms from the start of the study through 8 months. Additional sleep-related measures include nighttime awakenings, time to fall asleep, and bedtime routine consistency. The study also monitors how children respond to the interventions and collects data on their sleep and behavior over time.
CONDITIONS
Brief Title
Optimizing Attention and Sleep Intervention Study
Who Can Participate
Age: 3Years - 5Years
All Genders
Eligibility Criteria
You may qualify if you...
- Legal guardian is at least 18 years old
- Legal guardian reads and speaks English
- Child is between 3 and 5 years old
- Child has caregiver-reported 4 or more ADHD symptoms
- Caregiver reports child's sleep as a moderate or serious problem
- Child speaks English
- Child receives care from a participating pediatric primary care office
You will not qualify if you...
- Child has sleep interfering medical diagnoses such as narcolepsy or obstructive sleep apnea
- Child has a severe neurodevelopmental disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Outpatient Treatment
Duration - Approximately 4 months
Participants receive either a brief parent behavioral intervention or a sleep-focused parent behavioral intervention delivered by behavioral health therapists in pediatric primary care.
Multiple visits during the intervention period (frequency based on therapy schedule)
Follow-up
Duration - Up to 8 months from baseline
Participants are monitored to assess changes in sleep problems and ADHD symptoms after the intervention.
Periodic assessments during follow-up
Trial Site Locations
Total: 7 locations
1
Children's Community Pediatrics Bass Wolfson, Cranberry
Cranberry Township, Pennsylvania, United States, 16066
Actively Recruiting
2
Children's Community Pediatrics GIL Murrysville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
3
Children's Community Pediatrics Shenango
New Castle, Pennsylvania, United States, 16101
Actively Recruiting
4
Children's Community Pediatrics Neshannock
New Castle, Pennsylvania, United States, 16105
Not Yet Recruiting
5
Children's Community Pediatrics GIL East Liberty
Pittsburgh, Pennsylvania, United States, 15206
Actively Recruiting
6
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
7
Children's Community Pediatrics Bass Wolfson, Squirrel Hill
Pittsburgh, Pennsylvania, United States, 15217
Actively Recruiting
Loading map...
Research Team
H
Heather M Joseph, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
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.
Heather M Joseph, Jessica C Levenson, Rachel P K Conlon...
https://pubmed.ncbi.nlm.nih.gov/40001155