Sleep-Focused Parent Behavioral Intervention for Attention Deficit Hyperactivity Disorder (ADHD)
Study 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: Demonstrate acceptability, feasibility, and appropriateness of the SF-PBI. Examine change in sleep and ADHD symptoms among preschoolers with ADHD symptoms receiving SF-PBI compared to the brief PBI.
- Attention Deficit Hyperactivity Disorder (ADHD)
- Preschoolers
- Sleep
- Sleep Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 3 Secondary · Reporting Duration: Change from baseline up to 8 months
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Brief Parent Behavioral Intervention
1 of 2
Sleep-Focused Parent Behavioral Intervention
1 of 2
Active Control
Experimental Treatment
50 Total Participants · 2 Treatment Groups
Primary Treatment: Sleep-Focused Parent Behavioral Intervention · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 3 - 5 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| California | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
- 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.
- Heather Joseph 2023. "A Sleep Focused Parenting Intervention for Preschool Aged Children at Risk for ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05683756.