RECRUITING

Project PEAK: Early Intervention for ADHD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-09-01
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04627415

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 3- to 5.11-year old children with clinically significant symptoms of ADHD.
  2. * 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).
  1. * A diagnoses of autism spectrum disorder (ASD), pervasive developmental disorder, intellectual disability, neurological damage, or significant motor or physical impairments.
  2. * 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.

Contacts and Locations

Study Contact

George J DuPaul, Ph.D.
CONTACT
6107583252
gjd3@lehigh.edu
Lee Kern, Ph.D.
CONTACT
610-758-3267
lek6@lehigh.edu

Principal Investigator

George J DuPaul, Ph.D.
PRINCIPAL_INVESTIGATOR
Lehigh University
Lee Kern, Ph.D.
PRINCIPAL_INVESTIGATOR
Lehigh University

Study Locations (Sites)

Lehigh University
Bethlehem, Pennsylvania, 18015
United States

Collaborators and Investigators

Sponsor: Lehigh University

  • George J DuPaul, Ph.D., PRINCIPAL_INVESTIGATOR, Lehigh University
  • Lee Kern, Ph.D., PRINCIPAL_INVESTIGATOR, Lehigh University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-01
Study Completion Date2025-08

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • ADHD
  • Behavioral Parent Training
  • Early Intervention
  • Preschool

Additional Relevant MeSH Terms

  • Attention Deficit Hyperactivity Disorder
  • Parent-Child Relations
  • Child Behavior
  • Parenting