NCT04627415 Project PEAK: Early Intervention for ADHD
| NCT ID | NCT04627415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lehigh University |
| Condition | Attention Deficit Hyperactivity Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2020-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
George J DuPaul, Ph.D.
PRINCIPAL INVESTIGATOR
Lehigh University
Frequently Asked Questions
Who can join the NCT04627415 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 5 Years, studying Attention Deficit Hyperactivity Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04627415 currently recruiting?
Yes, NCT04627415 is actively recruiting participants. Contact the research team at gjd3@lehigh.edu for enrollment information.
Where is the NCT04627415 trial being conducted?
This trial is being conducted at Bethlehem, United States.
Who is sponsoring the NCT04627415 clinical trial?
NCT04627415 is sponsored by Lehigh University. The principal investigator is George J DuPaul, Ph.D. at Lehigh University. The trial plans to enroll 180 participants.