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Project PEAK: Early Intervention for ADHD
NCT04627415 · View on ClinicalTrials.gov ↗
Study Summary
Parent education is an effective and relatively cost efficient approach for reducing child behavior problems. Research, however, suggests that the effectiveness of parent education is mitigated by parent attendance and parent implementation of intervention strategies. That is, low attendance at parent education sessions is associated with limited intervention effects. Therefore, it is critical to identify strategies to enhance parent engagement. A previous pilot randomized controlled trial of a parent education program (Behavioral Parent Education; BPE, specifically Promoting Engagement for ADHD pre-Kindergartners \[PEAK\]), found that both face-to-face (F2F) and online BPE resulted in high levels of parent engagement and child behavior improvements. However, results need to be replicated in a full scale efficacy trial with a larger, diverse sample to provide more reliable estimates of relative effect sizes for parent and child outcomes and to evaluate the extent to which parent and child behavior changes are maintained after BPE has ended. In the current randomized controlled trial, the investigators intend to apply What Works Clearinghouse group design standards to examine the efficacy of two forms of delivery of BPE (F2F and online) relative to a wait-list control condition in a sample of 180, 3- to 5-year old children with clinically significant symptoms of ADHD. The objective is to: (a) extend findings from the pilot investigation to a large, diverse sample; (b) examine maintenance of effects; (c) identify moderators and mediators of treatment outcome, especially the degree to which these may differ for F2F vs. online treatment delivery; and (d) assess cost and cost-effectiveness of the two PEAK delivery formats.
Conditions Studied
Interventions
- BEHAVIORAL Promoting Engagement with ADHD Pre-Kindergarteners
Study Locations (1)
Pennsylvania
- Lehigh University — Bethlehem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04627415
The ClinicalTrials.gov registry entry for NCT04627415 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lehigh University, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention — of which Promoting Engagement with ADHD Pre-Kindergarteners is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04627415 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04627415 about?
NCT04627415 is a clinical study titled "Project PEAK: Early Intervention for ADHD". Parent education is an effective and relatively cost efficient approach for reducing child behavior problems. Research, however, suggests that the effectiveness of parent education is mitigated by parent attendance and parent implementation of intervention strategies. That is, low attendance at pare...
What is the current status of trial NCT04627415?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2020-09-01. Estimated completion is 2026-12-31.
What conditions does trial NCT04627415 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, Parenting, Parent-Child Relations, Child Behavior. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04627415?
The interventions under investigation include: Promoting Engagement with ADHD Pre-Kindergarteners (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04627415?
This trial is sponsored by Lehigh University, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04627415 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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