Actively Recruiting

Phase Not Applicable
Age: 3Years - 5Years
All Genders
Healthy Volunteers
NCT04627415

Project PEAK: Early Intervention for ADHD

Led by Lehigh University · Updated on 2025-09-09

180

Participants Needed

1

Research Sites

330 weeks

Total Duration

On this page

Sponsors

L

Lehigh University

Lead Sponsor

I

Institute of Education Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Project PEAK: Early Intervention for ADHD

Who Can Participate

Age: 3Years - 5Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 5 years 11 months with clinically significant ADHD symptoms
  • Diagnosis meeting DSM-5 criteria for one of the three ADHD presentations based on clinical interview and parent and teacher behavior ratings
  • Parent and teacher reports showing elevated impairment at home and school (score above 90th percentile on relevant behavior rating scales)
Not Eligible

You will not qualify if you...

  • Diagnosis of autism spectrum disorder, pervasive developmental disorder, intellectual disability, neurological damage, or significant motor or physical impairments
  • Children not enrolled in preschool or daycare at least 2 days per week unless unable due to behavioral or unrelated disability reasons

AI-Screening

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Trial Site Locations

Total: 1 location

1

Lehigh University

Bethlehem, Pennsylvania, United States, 18015

Actively Recruiting

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Research Team

G

George J DuPaul, Ph.D.

CONTACT

L

Lee Kern, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Project PEAK: Early Intervention for ADHD | DecenTrialz