Optimizing Attention and Sleep Intervention Study (NCT05683756) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Optimizing Attention and Sleep Intervention Study
United States50 participantsStarted 2023-12-01
Plain-language 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.
Who can participate
Age range
3 Years – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically looking at sleep disturbances alongside ADHD symptoms in young children — can you help me understand whether my child's sleep problems are significant enough that treating them alongside their ADHD symptoms might make a real difference?
2Since this trial is in Phase NA and seems focused on measuring whether the intervention is acceptable, appropriate, and feasible rather than proving it works, what does that mean for how much we'd actually know about whether it's effective or safe before my child participates?
3The study is listed as 'active not recruiting,' which means they're no longer enrolling new participants — are there similar sleep-and-ADHD intervention studies we could look into, or is there a standard treatment approach for preschool-aged children with both sleep issues and ADHD that we should consider first?
4If my child were part of a study like this, what kinds of demands would that typically place on our family in terms of time, appointments, or behavior tracking, and is our current situation realistic for that kind of commitment?
5Are there already established sleep interventions or behavioral therapies for preschoolers with ADHD that have more proven outcomes we should explore before considering an early-phase feasibility study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intervention Acceptability
Timeframe: Post Intervention at approximately 4 months
2
Intervention Appropriateness
Timeframe: Post Intervention at approximately 4 months
3
Intervention Feasibility
Timeframe: Post Intervention at approximately 4 months