Project PEAK: Early Intervention for ADHD

This study, called Project PEAK, is looking at an early intervention program for children aged 3 to 5 years old who have Attention Deficit Hyperactivity Disorder (ADHD). The program, "Promoting Engagement with ADHD Pre-Kindergarteners" (PEAK), is a behavioral intervention that includes strategies like optimism training. Researchers want to see if this program helps parents learn and use intervention strategies, improves their child's behavior, and if parents find the program acceptable. The study aims to enroll 180 participants. Children must have significant ADHD symptoms and meet specific diagnostic criteria. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 180 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will engage in 10 behavioral parent education sessions, each lasting approximately 1.5 hours.
Compensation
Not stated in the trial record.
Follow-up
The primary effects on parents' intervention strategies, child behavior, and program acceptability will be measured at 10 weeks after treatment.

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NCT04627415

Project PEAK: Early Intervention for ADHD

Recruiting
NAAges 3–5InterventionalTreatment
Lehigh University
~180 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:Promoting Engagement with ADHD Pre-Kindergarteners

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Post-Treatment Effects (Parent): Intervention Strategies
Measured over 10 weeks
+30 more outcomes measured
Attention Deficit Hyperactivity Disorder
Parent-Child Relations
Child Behavior
Parenting
1 sites across 1 states
Pennsylvania1
  • George J DuPaul, Ph.D. · PRINCIPAL_INVESTIGATOR · Lehigh University
  • Lee Kern, Ph.D. · PRINCIPAL_INVESTIGATOR · Lehigh University

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Eligibility criteria

Inclusion

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

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.
  • Post-Treatment Effects (Parent): Intervention Strategies10 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): Behavior10 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): Acceptability10 weeks

    To assess treatment acceptability the Intervention rating profile-15 (R= 15-90; higher scores = better outcomes) will be used.

  • Post-Treatment Effects (Parent): Stress10 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): Optimism10 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): Academics10 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): Behavior10 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 Observations10 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 Regulation10 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 Behaviors10 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 Behaviors10 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 Behaviors2 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 Observations2 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 Regulation2 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 Behaviors2 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): Acceptability2 years

    To assess maintenance of treatment acceptability the Intervention rating profile-15 (R= 15-90; higher scores = better outcomes) will be used.

  • Maintenance (Parent): Behavior2 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 Strategies2 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): Stress2 years

    To assess maintenance in parenting stress, The Parenting Stress Inventory-4 (R=36-180; higher scores = worse outcomes) will be used.

  • Maintenance (Parent): Optimism2 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 Completion2 years

    To examine parent session completion, a frequency count will be used (higher scores= better outcomes).

  • Mediators and Moderators (Parent): Demographics2 years

    To assess parent income, education, and marital status the Parent Demographic Information form will be used.

  • Mediators and Moderators (Parent): ADHD Symptoms2 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 Strategies2 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): Stress2 years

    To assess parent stress, the Parenting Stress Inventory (PSI) will be used (R=36-180; higher scores = worse outcomes).

  • Mediators and Moderators (Parent): Media2 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)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-face5 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-face5 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): Online5 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): Online5 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).