Behavior Parent Education for ADHD in Pre-Kindergarteners

(PEAK Trial)

Overseen By George J DuPaul, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Lehigh University

Disqualifiers: Autism, Intellectual disability, Neurological damage, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how teaching parents can improve behavior in young children with ADHD. It examines two training delivery methods: face-to-face sessions and online programs. The goal is to determine which method better engages parents and helps them manage their child's behavior effectively. This trial suits parents of 3- to 5-year-olds who exhibit significant ADHD symptoms and attend preschool or daycare at least twice a week. Participants will assist researchers in identifying the more cost-effective education method and assessing the duration of positive changes. As an unphased study, this trial allows parents to contribute to valuable research that could enhance ADHD management strategies for young children.

Do I have to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on parent education for managing ADHD in young children.

What prior data suggests that this parent education program is safe for pre-kindergarteners with ADHD?

Research shows that both online and in-person PEAK programs effectively reduce ADHD symptoms such as inattention and hyperactivity in young children. Studies have found that parents can easily follow these programs, and they do not cause harm. Parents report high engagement and satisfaction with both formats. No significant negative effects have been reported, suggesting the programs are safe for families. Overall, these parent education programs appear to be a reliable and safe option for managing ADHD symptoms in young children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PEAK program for ADHD in pre-kindergarteners because it offers a fresh approach to parent education with two unique delivery methods: online and face-to-face (F2F). Unlike traditional therapies that mostly focus on medication or in-person behavioral therapy, PEAK provides flexible learning options, allowing parents to choose between engaging online sessions or interactive face-to-face meetings. Additionally, both versions incorporate "optimistic training," aiming to reshape negative thought patterns about parenting and child behavior, which is not commonly addressed in standard treatments. This dual-format and optimism-focused strategy has the potential to make ADHD management more accessible and effective for families.

What evidence suggests that this trial's treatments could be effective for ADHD in pre-kindergarteners?

Research has shown that teaching parents how to manage their child's behavior, a key part of the PEAK program, effectively reduces ADHD symptoms in preschool children. In this trial, participants will join either the in-person or online version of the PEAK program. Previous studies have shown that both versions increase parent involvement and improve children's behavior. These studies demonstrated high levels of parent participation and better child behavior, which are essential for the program's success. The PEAK approach provides parents with strategies to handle their child's behavior, proving effective for young children with ADHD. Various research findings support the program's success in involving parents and improving children's outcomes. ^{2 4 6 7 8}

Who Is on the Research Team?

George J DuPaul, Ph.D.

Principal Investigator

Lehigh University

Lee Kern, Ph.D.

Principal Investigator

Lehigh University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Children who have been diagnosed with ADHD by a doctor through clinical interview and have shown signs of ADHD at home and school according to their parents and teachers.

Exclusion Criteria

My child attends preschool or daycare at least 2 days a week, unless unable due to specific issues.

You have been diagnosed with autism spectrum disorder (ASD), intellectual disability, or significant physical or neurological impairments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Behavioral Parent Education (BPE) through either face-to-face or online sessions, consisting of 10 sessions each lasting 1.5 hours

10 weeks

10 sessions (in-person or online)

Post-Treatment Effects

Assessment of changes in child early academic skills, social behaviors, and parent intervention strategies

10 weeks

Follow-up

Participants are monitored for maintenance of treatment effects, including parent and child behavior, stress, and intervention strategy use

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Promoting Engagement with ADHD Pre-Kindergarteners (PEAK)

Trial Overview 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.

How Is the Trial Designed?

Group I: Waitlist Control Experimental Treatment 1 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 Treatment Experimental Treatment 1 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 Treatment Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Lehigh University

Lead Sponsor

Trials

24

Recruited

6,800+

Institute of Education Sciences

Collaborator

Trials

10

Recruited

3,200+

Institute of Education Sciences (IES)

Collaborator

Trials

2

Recruited

800+

Published Research Related to This Trial

A psychoeducation program for families of children with ADHD significantly reduced total ADHD symptoms and inattention/cognition issues, with medium-large effect sizes, based on parent reports from a study involving 69 participants.

The positive effects of the psychoeducation program persisted for at least 6 months after the intervention, suggesting it is an effective and valid approach to managing ADHD symptoms alongside standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial Evaluating the Efficacy of a Psychoeducation Program for Families of Children and Adolescents With ADHD in the United Kingdom: Results After a 6-Month Follow-Up. Ferrin, M., Perez-Ayala, V., El-Abd, S., et al.[2021]

A randomized controlled trial involving 164 preschool children with ADHD showed that a structured parent training program significantly improved parent-reported ADHD symptoms compared to usual care, with effects lasting up to 36 weeks after treatment.

The parent training program also enhanced parenting self-efficacy and reduced family strain, but did not show any impact on teacher ratings, direct observations of ADHD symptoms, or child conduct problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent Training for Preschool ADHD in Routine, Specialist Care: A Randomized Controlled Trial. Lange, AM., Daley, D., Frydenberg, M., et al.[2019]

A systematic review of 16 studies found that group-based parent education programs can effectively improve behavior problems in children aged 3 to 10, leading to positive changes in both parental perceptions and children's behavior.

Despite the promising results, the review highlighted significant variability in the interventions and populations studied, suggesting that more controlled studies are needed before broadly applying these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior problems and group-based parent education programs. Barlow, J., Stewart-Brown, S.[2019]

Integrating behavioral parent training (BPT) into pediatric primary care settings is a promising approach to increase access for families, especially in low-income, predominantly Black communities.

The adaptations made to the BPT program were found to be feasible and acceptable, successfully engaging families and transforming the practices of primary care providers, which can help reduce behavioral health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting a preschool disruptive behavior group for the underserved in pediatric primary care practice. Raglin Bignall, WJ., Herbst, RB., McClure, JM., et al.[2023]

In a study of 73 children with ADHD and disruptive behaviors, home-based behavioral parent training significantly reduced the severity of disruptive behaviors and ADHD symptoms compared to a waiting list and standard care, with effect sizes indicating moderate to large improvements.

The training was particularly effective in addressing oppositional-defiant disorder symptoms, suggesting that it can be a valuable intervention for children who continue to struggle after traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based parent training for school-aged children with attention-deficit/hyperactivity disorder and behavior problems with remaining impairing disruptive behaviors after routine treatment: a randomized controlled trial. Nobel, E., Hoekstra, PJ., Agnes Brunnekreef, J., et al.[2022]

Parent training (PT) is recommended as the first-line treatment for preschool children with ADHD, highlighting its importance in managing this prevalent neuro-developmental disorder.

The review evaluates three different PT programs in Denmark that have been assessed through randomized controlled trials (RCTs), providing evidence for their effectiveness in addressing ADHD symptoms in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[ADHD in preschoolers and early parent training interventions]. Lange, AM., Thomsen, PH.[2020]

A randomized controlled trial involving 56 preschool children with ADHD showed that group-based behavioral parent training (BPT) is as effective as individual BPT in reducing ADHD severity over 12 weeks.

Both group and individual BPT significantly reduced parental stress and improved coping strategies, indicating that group BPT is a feasible and effective treatment option in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of brief group behavioural parent training with individual parent training for preschool children with attention deficit hyperactivity disorder: A randomized feasibility study. Vaidyanathan, S., Chandrasekaran, V., Kandasamy, P.[2023]

Behavioral Parent Training (BPT) is an effective first-line treatment for children with ADHD under six years old and a recommended combination treatment for older children, showing significant improvements in problem behaviors like inattention and hyperactivity.

The study demonstrated that BPT significantly improved parenting practices, as evidenced by changes in Parenting Scale scores, indicating that it can reduce negative parenting behaviors and enhance outcomes for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a Behavioral Parent Training Program for Parents of ADHD Children Improve Outcomes? A Pilot Project. Morgan, TC., O'Keefe, LC.[2021]

Citations

1. ed.lehigh.edu ed.lehigh.edu/research/project-peak

Project PEAK | Lehigh College of Education The project is designed to target the issues of young children (ages 3-5) exhibiting early behavioral symptoms of attention-deficit/hyperactivity disorder (ADHD) ...

2. files.eric.ed.gov files.eric.ed.gov/fulltext/EJ1179235.pdf

Promoting Parent Engagement in Behavioral Intervention for ... Results indicated that the revised program and online versions (a) increased parent engagement with BPT, (b) enhanced accessibility, (c) produced favorable ...

3. withpower.com withpower.com/trial/phase-attention-deficit-disorder-with-hyperactivity-8-2020-e4609

Behavior Parent Education for ADHD in Pre-Kindergarteners · ... Research shows that behavioral parent training (BPT), which is a key component of PEAK, is effective in reducing ADHD symptoms in preschool children. Studies ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0271121417746220

Promoting Parent Engagement in Behavioral Intervention ... The most efficacious psychosocial intervention for reducing attention-deficit/hyperactivity disorder (ADHD) symptoms in young children is behavioral parent ...

5. ctv.veeva.com ctv.veeva.com/study/project-peak-early-intervention-for-adhd

Project PEAK: Early Intervention for ADHD - ClinicalTrials.Veeva Parent education is an effective and relatively cost efficient approach for reducing child behavior problems.

6. ies.ed.gov ies.ed.gov/use-work/awards/early-intervention-young-children-risk-adhd-evaluating-efficacy-and-delivery-format-behavioral

Early Intervention for Young Children At Risk for ADHD The primary aim of the initial efficacy study is to examine the effects of face-to-face and online behavioral parent education (BPE), using the intervention ...

7. ies.ed.gov ies.ed.gov/use-work/awards/early-intervention-young-children-adhd-developing-strategies-enhance-parent-engagement

Early Intervention for Young Children with ADHD: Developing ... The purpose of this project was to further develop and refine a parent education program to increase parent engagement with early intervention for young ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28715272/

Face-to-Face Versus Online Behavioral Parent Training for ... Findings indicate a streamlined BPT delivered online or F2F results in high levels of engagement, acceptability, as well as parent treatment knowledge and ...