What side effects are associated with this type of intervention?

The most common treatments for ADHD include stimulant medications like methylphenidate and behavioral interventions such as Behavioral Parent Education (BPE). Known side effects of stimulant medications include decreased appetite, nausea, vomiting, and insomnia. Behavioral interventions like BPE, which focus on enhancing parent engagement and implementation of strategies to reduce child behavior problems, generally do not have direct side effects but require consistent parent participation and implementation to be effective.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulant medications like methylphenidate and amphetamines, which are commonly used due to their efficacy in reducing core symptoms of ADHD. Non-stimulant medications such as atomoxetine and guanfacine have also been approved and are used as alternatives, particularly for patients who may not tolerate stimulants well. In addition to pharmacological treatments, behavioral interventions like Behavioral Parent Training (BPT) and Behavioral Classroom Management (BCM) are well-established and focus on enhancing parent engagement and implementing strategies to reduce child behavior problems, similar to the goals of Behavioral Parent Education (BPE).

What other types of research exist?

Promising, novel alternatives to Behavioral Parent Education (BPE) for ADHD patients include: 1) Telephone-assisted self-help (TASH) parenting behavioral intervention, which combines written materials with telephone counseling to enhance the effects of medication. 2) Mindfulness-based interventions, which have shown benefits for parents and children with ADHD in terms of coping and quality of life. These alternatives focus on enhancing parent engagement and implementation of intervention strategies, similar to BPE.

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Behavioural Intervention

Behavior Parent Education for ADHD in Pre-Kindergarteners (PEAK Trial)

N/A

Recruiting

Led By George J DuPaul, Ph.D.

Research Sponsored by Lehigh University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

3- to 5.11-year old children with clinically significant symptoms of ADHD.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a parent training program called PEAK for parents of young children with ADHD. The program teaches practical strategies to manage behavior and improve early academic skills through interactive sessions available both face-to-face and online.

Who is the study for?

This trial is for children aged 3 to nearly 6 with ADHD symptoms, who meet the criteria for ADHD based on interviews and behavior ratings. They should be in preschool or daycare at least twice a week unless they can't due to behavioral issues or disabilities unrelated to ASD, intellectual disability, or significant physical impairments.

What is being tested?

Project PEAK tests how effective parent education programs are in managing child behavior problems related to ADHD. It compares two ways of delivering this training: face-to-face and online, against a wait-list control group. The study aims to see which method keeps parents more engaged and helps maintain improvements over time.

What are the potential side effects?

Since this trial involves educational interventions rather than medication, traditional side effects are not expected. However, there may be indirect effects such as increased stress or time commitment for participating families.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child, aged 3-5 years, shows significant ADHD symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cost-Effectiveness (money): Face-to-face

Cost-Effectiveness (money): Online

Cost-Effectiveness (time): Face-to-face

+27 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Waitlist ControlExperimental Treatment1 Intervention

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.

Group II: Online TreatmentExperimental Treatment1 Intervention

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.

Group III: Face to Face TreatmentExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ADHD include pharmacological and behavioral interventions. Stimulant medications like methylphenidate and amphetamines increase dopamine and norepinephrine levels in the brain, improving attention and reducing hyperactivity and impulsivity. Non-stimulant medications such as atomoxetine selectively inhibit norepinephrine reuptake. Behavioral interventions, such as Behavioral Parent Education (BPE), enhance parent engagement and teach effective behavior management strategies. These combined approaches address both neurobiological and environmental factors, leading to more comprehensive and effective symptom management for ADHD patients.