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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
PEAK Trial Summary
This trial is examining the efficacy of two forms of delivery of behavior parent education (face-to-face and online) for reducing symptoms of ADHD in children aged 3-5, relative to a wait-list control condition. The objective is to see if the results from a previous smaller trial can be replicated with a larger and more diverse sample, and to assess the cost and cost-effectiveness of the two delivery formats.
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.Check my eligibility
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.See study design
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.
PEAK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child, aged 3-5 years, shows significant ADHD symptoms.
PEAK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cost-Effectiveness (money): Face-to-face
Cost-Effectiveness (money): Online
Cost-Effectiveness (time): Face-to-face
+27 morePEAK 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.
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Who is running the clinical trial?
Institute of Education SciencesFED
8 Previous Clinical Trials
3,032 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
359 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Lehigh UniversityLead Sponsor
21 Previous Clinical Trials
4,130 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
386 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Institute of Education Sciences (IES)UNKNOWN
1 Previous Clinical Trials
615 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child, aged 3-5 years, shows significant ADHD symptoms.My child attends preschool or daycare at least 2 days a week, unless unable due to specific issues.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.You have been diagnosed with autism spectrum disorder (ASD), intellectual disability, or significant physical or neurological impairments.
Research Study Groups:
This trial has the following groups:- Group 1: Face to Face Treatment
- Group 2: Online Treatment
- Group 3: Waitlist Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study accept participants under the age of 30?
"This research study is open to participants aged between 3 and 5 years old."
Answered by AI
Do I meet the prerequisites for partaking in this medical experiment?
"This research is aimed at recruiting 180 children aged 3 to 5 years with a current diagnosis of ADHD. To be eligible, they must meet the DSM-5 criteria based on clinical interviews and score above the 90th percentile in one or more Conners Early Childhood Rating Scale subscales that are relevant to this condition."
Answered by AI
What is the enrollment number for this clinical experiment?
"Affirmative. Clinicaltrials.gov shows that this trial, which was first made available on September 1st 2020, is actively recruiting participants. The study aims to enroll 180 patients from a single medical centre."
Answered by AI
Are there still vacancies within this research project?
"Clinicaltrials.gov records that this medical research is actively recruiting participants, as the trial was first advertised on September 1st 2020 and has been recently updated on April 4th 2022."
Answered by AI
Who else is applying?
What site did they apply to?
Lehigh University
What portion of applicants met pre-screening criteria?
Met criteria
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