Improving sleep and attention in young children
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
This study is testing a new sleep-focused program for parents to see if it can help young children with sleep problems and early signs of ADHD feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 5 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 7 sites (Cranberry Township, Pennsylvania and 6 other locations) |
| Trial ID | NCT05683756 on ClinicalTrials.gov |
What this trial studies
This pilot clinical effectiveness trial aims to compare a brief parent behavioral intervention (PBI) with a modified sleep-focused PBI (SF-PBI) for families of children aged 3-5 years who exhibit sleep problems and early symptoms of ADHD. The study will assess the acceptability and feasibility of the SF-PBI delivered by therapists in pediatric primary care settings. Additionally, it will evaluate changes in sleep engagement and ADHD symptoms among participants receiving the SF-PBI compared to those receiving standard PBI. This research seeks to address the link between sleep disturbances and the risk of developing ADHD in young children.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-5 years with reported sleep problems and at least four ADHD symptoms, along with their English-speaking caregivers.
Not a fit: Patients with sleep-interfering medical diagnoses or severe neurodevelopmental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and reduce ADHD symptoms in preschool-aged children.
How similar studies have performed: While this approach is innovative, similar studies targeting sleep issues in relation to ADHD have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea) * (2) Severe neurodevelopmental disorder
Where this trial is running
Cranberry Township, Pennsylvania and 6 other locations
- Children's Community Pediatrics Bass Wolfson, Cranberry — Cranberry Township, Pennsylvania, United States (Recruiting)
- Children's Community Pediatrics GIL Murrysville — Monroeville, Pennsylvania, United States (Recruiting)
- Children's Community Pediatrics Shenango — New Castle, Pennsylvania, United States (Recruiting)
- Children's Community Pediatrics Neshannock — New Castle, Pennsylvania, United States (Not_yet_recruiting)
- Children's Community Pediatrics GIL East Liberty — Pittsburgh, Pennsylvania, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Children's Community Pediatrics Bass Wolfson, Squirrel Hill — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Heather M Joseph, DO — Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh
- Study coordinator: Heather M Joseph, DO
- Email: liebherrh@upmc.edu
- Phone: 4122465338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.