Clinical trial Recruiting at 1 site Interventional Ages 3 to 5

Early intervention program for preschoolers with ADHD

Official title: Early Intervention for Young Children At-Risk for ADHD: Evaluating Efficacy and Delivery Format for Behavioral Parent Education

Run by Lehigh University · NCT04627415 · Data updated 2026-11-12

This study is testing a new program that helps parents of preschoolers with ADHD learn strategies to manage their child's symptoms and improve their relationship, making it easier for families to get support.

Quick facts

Study typeInterventional
Ages3 Years to 5 Years
SexAll
Enrollment180 (estimated)
SponsorLehigh University
Academic / other
Locations1 site (Bethlehem, Pennsylvania)
StatusRecruiting
StartedSeptember 1, 2020
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedSeptember 9, 2025
Trial IDNCT04627415 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 3 to 5.11 years who exhibit clinically significant symptoms of ADHD and are enrolled in a preschool or daycare setting.

Probably not a fit

Patients with diagnoses of autism spectrum disorder, intellectual disabilities, or significant physical impairments may not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This program focuses on enhancing parent engagement through a series of 10 educational sessions designed for parents of preschoolers diagnosed with ADHD. The sessions, which can be attended either face-to-face or online, cover various strategies for managing ADHD symptoms and improving parent-child interactions. The approach aims to address barriers to treatment access by providing flexible scheduling and reducing the overall time commitment compared to traditional programs. The effectiveness of this intervention will be evaluated through a full-scale efficacy trial with a diverse sample of participants.

Why it matters

Potential benefit: If successful, this program could significantly improve behavioral outcomes for children with ADHD and enhance parent-child relationships.

How similar studies have gone: Previous pilot studies have shown promising results with similar parent education approaches, indicating potential for success in this larger trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 3- to 5.11-year old children with clinically significant symptoms of ADHD.
* Children had to have met DSM-5 criteria for one of the three presentations of ADHD based on clinical interview and parent and teacher behavior ratings, including parent and teacher report of elevated levels of impairment at home and school (i.e., score greater than 90th percentile on one or more Conners Early Childhood Rating Scale subscales relevant to ADHD).

Exclusion Criteria:

* A diagnoses of autism spectrum disorder (ASD), pervasive developmental disorder, intellectual disability, neurological damage, or significant motor or physical impairments.
* Children needed to be enrolled in a pre-school or day care setting at least 2 days a week unless otherwise unable to enroll (e.g. behavioral problems, lack of services for unrelated disability) in order to establish the presence of symptoms across two settings.

Where it's running

  • Lehigh University
    Bethlehem, Pennsylvania, United States
    Recruiting

Study contacts

  • Principal investigator: George J DuPaul, Ph.D. — Lehigh University
  • Study coordinator: George J DuPaul, Ph.D.
  • Email: gjd3@lehigh.edu
  • Phone: 6107583252

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.