Recruiting

ADHD

Sponsor:

Lehigh University

Code:

NCT04627415

Conditions

Attention Deficit Hyperactivity Disorder

Parent-Child Relations

Child Behavior

Parenting

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Accepted

Interventions

Promoting Engagement with ADHD Pre-Kindergarteners

Study Details

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.

Conditions

Attention Deficit Hyperactivity Disorder

Parent-Child Relations

Child Behavior

Parenting

Study ID

NCT04627415

Start date

Sep 1, 2020

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Face to Face Treatment

The F2F version of PEAK contains 10 BPE sessions (1.5 hours each). Session content includes: 1) Introduction to ADHD, 2) Attending, Rewards and Ignoring, 3) General Behavior Management Strategies, 4) Problem-Solving Approach, 5) Preventive Intervention, 6) Instructive Interventions, 7) Response Strategies, 8) Extending What Works to Community Settings, 9) Promoting Early Reading and Math Skills, and 10) Effective Communication Strategies. Each session contains didactic instruction and activities designed to enhance engagement. Sessions include video examples and interactive activities. Weekly homework is assigned for strategy practice. At the start of the following session, the leader checks in with families on the use of the chosen strategy. The session leader praises successes and troubleshoots challenges. The intervention also includes optimistic training which aims to identify/improve pessimistic thinking patterns that parents have about their parenting and child's behaviors.

experimental: Online Treatment

For the online version of the program, in addition to content regarding an overview of ADHD, the initial session consists of brief video clips demonstrating how to access PEAK sessions on the Internet, and an orientation to online content (e.g., handouts, interactive chat sessions, research team contact links). Prior to the session, parents are provided with password-protected individual access codes. Similar to the F2F program, check-ins are provided weekly via each parent's preferred mode of communication (i.e., text, internet, phone) to query strategies implemented, praise success, and troubleshoot alternative strategies. Parents in the online condition will also receive supplemental optimistic training to improve pessimistic thinking patterns about their child and parenting.

other: Waitlist Control

The comparison condition is a waitlist control group that will receive no intervention throughout the intervention timeframe. Instead, participants will receive wellness information about typical child development and constructs unrelated to the intervention content. Subsequent to the 12-month follow-up assessment, they will be provided access to the online version of the program. To encourage ongoing participation in the absence of services, parents will be informed that, at the end of the intervention timeframe, they will receive support (i.e., weekly contact to answer questions) while they complete the online program.

Interventions

Promoting Engagement with ADHD Pre-Kindergarteners

Optimism Training includes the following strategies: 1) Identifying situations and associations 2) Determining consequences of beliefs 3) Use distractions to interrupt negative thinking 4) dispute current thinking 5) substitute positive, productive thoughts 6) practice skills to recognize/modify self-talk 7) Maintain positive changes in self-talk

Primary outcome measure

  • Post-Treatment Effects (Parent): Intervention Strategies [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Parent): Behavior [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Parent): Acceptability [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Parent): Stress [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Parent): Optimism [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Child): Academics [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Child): Behavior [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Child): Behavior Observations [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Child): Self Regulation [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Child): Bedtime Behaviors [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Child): Social Behaviors [ Time Frame: 10 weeks ]
  • Post-Treatment Effects (Child): Social Behaviors [ Time Frame: 2 years ]
  • Maintenance (Child): Behavior Observations [ Time Frame: 2 years ]
  • Maintenance (Child): Self Regulation [ Time Frame: 2 years ]
  • Maintenance (Child): Bedtime Behaviors [ Time Frame: 2 years ]
  • Maintenance (Parent): Acceptability [ Time Frame: 2 years ]
  • Maintenance (Parent): Behavior [ Time Frame: 2 years ]
  • Maintenance (Parent): Intervention Strategies [ Time Frame: 2 years ]
  • Maintenance (Parent): Stress [ Time Frame: 2 years ]
  • Maintenance (Parent): Optimism [ Time Frame: 2 years ]
  • Mediators and Moderators (Parent): Session Completion [ Time Frame: 2 years ]
  • Mediators and Moderators (Parent): Demographics [ Time Frame: 2 years ]
  • Mediators and Moderators (Parent): ADHD Symptoms [ Time Frame: 2 years ]
  • Mediators and Moderators (Parent): Parent Strategies [ Time Frame: 2 years ]
  • Mediators and Moderators (Parent): Stress [ Time Frame: 2 years ]
  • Mediators and Moderators (Parent): Media [ Time Frame: 2 years ]
  • Mediators and Moderators (Child) [ Time Frame: 2 years ]
  • Cost-Effectiveness (money): Face-to-face [ Time Frame: 5 years ]
  • Cost-Effectiveness (time): Face-to-face [ Time Frame: 5 years ]
  • Cost-Effectiveness (time): Online [ Time Frame: 5 years ]
  • Cost-Effectiveness (money): Online [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

George J DuPaul, Ph.D.

6107583252gjd3@lehigh.edu

Lee Kern, Ph.D.

610-758-3267lek6@lehigh.edu

Locations

Lehigh University

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

George DuPaul, Ph.D.

6107583252gjd3@lehigh.edu

Alicia M Chunta, M.Ed.

610-758-5270inpeak@lehigh.edu

More Information

Sponsor

Lehigh University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • ADHD
  • Behavioral Parent Training
  • Early Intervention
  • Preschool

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lehigh University on 2025-09-09.