NCT04627415 · Lehigh University
Project PEAK: Early Intervention for ADHD
(PEAK)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Post-Treatment Effects (Parent): Intervention Strategies
Time frame: 10 weeks
To assess changes in intervention strategy use the test of parent knowledge (R= 0-15) and parent fidelity (R= 0-9) form will be used (higher scores = better outcomes).
Post-Treatment Effects (Parent): Behavior
Time frame: 10 weeks
To assess changes in parent behavior the Parenting Young Children (R= 22-154; higher scores = better outcomes), the DPICS and RPC (higher scores on negative codes = worse outcomes and higher scores on positive codes = better outcomes)
Post-Treatment Effects (Parent): Acceptability
Time frame: 10 weeks
To assess treatment acceptability the Intervention rating profile-15 (R= 15-90; higher scores = better outcomes) will be used.
Post-Treatment Effects (Parent): Stress
Time frame: 10 weeks
To assess chases in parenting stress, The Parenting Stress Inventory-4 (R=36-180; higher scores = worse outcomes) will be used.
Post-Treatment Effects (Parent): Optimism
Time frame: 10 weeks
To examine parental optimism post-treatment group comparisons, the Parental Attribution Measure (R= 0-12; higher scores = worse outcomes); The Family Empowerment Scale-Competence (R= 8-40; higher scores = better outcomes), and the Questionnaire on Resources and Stress-Pessimism (R=0-11; higher scores = worse outcomes) will be used.
Post-Treatment Effects (Child): Academics
Time frame: 10 weeks
To assess changes in child early academic skills the Individual Growth and Development Indicators of Early Learning (R=2.16-36.61; higher scores indicate better outcomes) will be used.
Post-Treatment Effects (Child): Behavior
Time frame: 10 weeks
To examine changes in child behavior the Conners-EC Rating Scale (R=0-100, higher scores indicate worse outcomes except for the developmental milestones)
Post-Treatment Effects (Child): Behavior Observations
Time frame: 10 weeks
To examine changes in child behavior the Dyadic Parent-Child Interactive Coding System-Revised (DPICS) and Relationship Process Code-2 (RPC) (higher scores on negative codes = worse outcomes and higher scores on positive codes = better outcomes)
Post-Treatment Effects (Child): Self Regulation
Time frame: 10 weeks
To examine changes in child self-regulation, the Head-Toes-Knees-Shoulders-Task (R=0-16; higher scores indicate better outcomes)
Post-Treatment Effects (Child): Bedtime Behaviors
Time frame: 10 weeks
To examine changes in child bedtime behaviors behaviors the Children's Sleep-Wake Scale-GTBS (R=5-30; higher scores indicate better outcomes).
Post-Treatment Effects (Child): Social Behaviors
Time frame: 10 weeks
To assess changes in child social behaviors the Adaptive Social Behavior Inventory (R=30-90; higher scores indicate worse outcomes) will be used
Post-Treatment Effects (Child): Social Behaviors
Time frame: 2 years
To assess maintenance in child social behaviors the Adaptive Social Behavior Inventory (R=30-90; higher scores indicate worse outcomes) will be used
Maintenance (Child): Behavior Observations
Time frame: 2 years
To examine maintenance in child behavior the Dyadic Parent-Child Interactive Coding System-Revised (DPICS) and Relationship Process Code-2 (RPC) (higher scores on negative codes = worse outcomes and higher scores on positive codes = better outcomes)
Maintenance (Child): Self Regulation
Time frame: 2 years
To examine maintenance in child self-regulation, the Head-Toes-Knees-Shoulders-Task (R=0-16; higher scores indicate better outcomes)
Maintenance (Child): Bedtime Behaviors
Time frame: 2 years
To examine maintenance in child bedtime behaviors behaviors the Children's Sleep-Wake Scale-GTBS (R=5-30; higher scores indicate better outcomes).
Maintenance (Parent): Acceptability
Time frame: 2 years
To assess maintenance of treatment acceptability the Intervention rating profile-15 (R= 15-90; higher scores = better outcomes) will be used.
Maintenance (Parent): Behavior
Time frame: 2 years
To assess maintenance in parent behavior the Parenting Young Children (R= 22-154; higher scores = better outcomes), the DPICS and RPC (higher scores on negative codes = worse outcomes and higher scores on positive codes = better outcomes)
Maintenance (Parent): Intervention Strategies
Time frame: 2 years
To assess maintenance in intervention strategy use the test of parent knowledge (R= 0-15) and parent fidelity (R= 0-9) form will be used (higher scores = better outcomes).
Maintenance (Parent): Stress
Time frame: 2 years
To assess maintenance in parenting stress, The Parenting Stress Inventory-4 (R=36-180; higher scores = worse outcomes) will be used.
Maintenance (Parent): Optimism
Time frame: 2 years
To examine maintenance in parental optimism, the Parental Attribution Measure (R= 0-12; higher scores = worse outcomes), The Family Empowerment Scale-Competence (R= 8-40; higher scores = better outcomes), and the Questionnaire on Resources and Stress-Pessimism (R=0-11; higher scores = worse outcomes) will be used.
Mediators and Moderators (Parent): Session Completion
Time frame: 2 years
To examine parent session completion, a frequency count will be used (higher scores= better outcomes).
Mediators and Moderators (Parent): Demographics
Time frame: 2 years
To assess parent income, education, and marital status the Parent Demographic Information form will be used.
Mediators and Moderators (Parent): ADHD Symptoms
Time frame: 2 years
Parent ADHD symptoms will be assessed using the Adult Investigator Symptom Rating Scale (R=18-90; higher scores= worse outcomes).
Mediators and Moderators (Parent): Parent Strategies
Time frame: 2 years
The test of parent knowledge (R= 0-15) and fidelity checklist (R= 0-9) (higher scores = better outcomes) will be used.
Mediators and Moderators (Parent): Stress
Time frame: 2 years
To assess parent stress, the Parenting Stress Inventory (PSI) will be used (R=36-180; higher scores = worse outcomes).
Mediators and Moderators (Parent): Media
Time frame: 2 years
Parent media use preference the Media and Technology Usage and Attitudes Scale (MTUAS) (R=45-506; higher scores = better outcomes) will be used.
Mediators and Moderators (Child)
Time frame: 2 years
To assess child self regulation the Head-Toes-Knees-Shoulders-Task (HTSK) will be used (R=0-16; higher scores indicate better outcomes).
Cost-Effectiveness (money): Face-to-face
Time frame: 5 years
Investigators will determine costs of the F2F program using the ingredients method by documenting cost of: (a) session leader, based on required minimal qualifications and salary for position ($); (b) space to run sessions ($ to rent out space) (d) food provided during session ($ for cost of food); (c) childcare provided during session ($ for childcare per hour); and (d) transportation, calculated by number of families needing transportation divided by total number of families (multiplied by average miles round trip x average Uber fare). Investigators will review effectiveness metrics by stratifying participants based on their characteristics (parent education level, socioeconomic index, ADHD medication status) prior to the intervention. Investigators will compare cost against effectiveness using Incremental Cost-Effectiveness Ratio (ICER).
Cost-Effectiveness (time): Face-to-face
Time frame: 5 years
Investigators will determine costs of the F2F program using the ingredients method by documenting time of: Individual contact hours by provider with minimal qualifications to support families between sessions (calculated as minutes of contact across efficacy trial divided by number of families). Investigators will review effectiveness metrics by stratifying participants based on their characteristics (parent education level, socioeconomic index, ADHD medication status) prior to the intervention. Investigators will compare cost against effectiveness using Incremental Cost-Effectiveness Ratio (ICER).
Cost-Effectiveness (time): Online
Time frame: 5 years
For the online program, we will determine costs (in time) of (a) individual contact hours by provider with minimal qualifications to support families between sessions, calculated as minutes of contact across efficacy trial divided by number of families; (b) technology support for families, as provided by technology expert with minimal qualifications and calculated as minutes spent supporting families with user challenges divided by total number of families in efficacy trial; and (c) technology support on creator end, as provided by technology expert with minimal qualifications and calculated as minutes spent. Investigators will review effectiveness metrics by stratifying participants based on their characteristics (parent education level, socioeconomic index, ADHD medication status) prior to the intervention. Investigators will compare cost against effectiveness using Incremental Cost-Effectiveness Ratio (ICER).
Cost-Effectiveness (money): Online
Time frame: 5 years
For the online program, we will determine costs of purchase of phone and data plan for approximately 10% of families without internet access. Investigators will review effectiveness metrics by stratifying participants based on their characteristics (parent education level, socioeconomic index, ADHD medication status) prior to the intervention. Investigators will compare cost against effectiveness using Incremental Cost-Effectiveness Ratio (ICER).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Bethlehem, Pennsylvania
Collaborators
Institute of Education Sciences
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations