Early intervention program for preschoolers with ADHD
Early Intervention for Young Children At-Risk for ADHD: Evaluating Efficacy and Delivery Format for Behavioral Parent Education
NA · Lehigh University · NCT04627415
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 3 Years to 5 Years |
| Sex | All |
| Sponsor | Lehigh University (other) |
| Locations | 1 site (Bethlehem, Pennsylvania) |
| Trial ID | NCT04627415 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with diagnoses of autism spectrum disorder, intellectual disabilities, or significant physical impairments may not benefit from this intervention.
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 performed: Previous pilot studies have shown promising results with similar parent education approaches, indicating potential for success in this larger trial.
Eligibility criteria
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 this trial is running
Bethlehem, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Attention Deficit Hyperactivity Disorder, Parent-Child Relations, Child Behavior, Parenting, ADHD, Behavioral Parent Training, Early Intervention, Preschool