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NCT04627415 · ClinicalTrials.gov registry record · NA

Project PEAK: Early Intervention for ADHD

A NA study of Attention Deficit Hyperactivity Disorder and Parenting, sponsored by Lehigh University.

Recruiting
Registry status
NA
Development phase
180
Enrollment target
1
Study location

NCT04627415: Recruiting NA study of Attention Deficit Hyperactivity Disorder and Parenting, sponsored by Lehigh University.

NCT04627415 is a NA study of Attention Deficit Hyperactivity Disorder and Parenting that is actively recruiting participants, run by Lehigh University. The registered enrollment target is 180 participants, below the 215-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (16% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04627415, a NA study of Attention Deficit Hyperactivity Disorder and Parenting, is actively recruiting participants, sponsored by Lehigh University.

RECRUITING
Registry status
NA
Development phase
180 participants
Enrollment target
1
Study location

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.

Primary Outcome

To assess changes in intervention strategy use the test of parent knowledge (R= 0-15) and parent fidelity (R= 0-9) form will be used (higher scores = better outcomes).

Conditions Studied

Attention Deficit Hyperactivity Disorder Parenting Parent-Child Relations Child Behavior

Interventions

  • BEHAVIORAL Promoting Engagement with ADHD Pre-Kindergarteners

Study Locations (1)

Pennsylvania

  • Lehigh University - Bethlehem

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2020-09-01
Est. Completion 2026-12-31
Phase NA
Lehigh University

12 total trials

What NCT04627415 shows while recruiting

NCT04627415 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 215-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (16% lower).

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.

NCT04627415 reports a single indexed study location in Pennsylvania.

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.

What interventions are being tested in trial NCT04627415?

The interventions under investigation include: Promoting Engagement with ADHD Pre-Kindergarteners (BEHAVIORAL).

Who is sponsoring clinical trial NCT04627415?

This trial is sponsored by Lehigh University, which has 12 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Attention Deficit Hyperactivity Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04627415's enrollment target sits among peer trials

180 36th of 102 higher than 67 of 102 other Attention Deficit Hyperactivity Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04627415

Source: ClinicalTrials.gov NCT04627415, the US trial registry maintained by the National Library of Medicine. NCT04627415 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.