Project PEAK: Early Intervention for ADHD

NCT04627415 | Recruiting

• 1 other identifier: IES: R324A200010
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder; Parent-Child Relations; Child Behavior; Parenting

Keywords

ADHD; Behavioral Parent Training; Early Intervention; Preschool

Outcome Measures

Primary Outcomes (31)

• Post-Treatment Effects (Parent): Intervention Strategies

  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).

  10 weeks

• Post-Treatment Effects (Parent): Behavior

  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)

  10 weeks

• Post-Treatment Effects (Parent): Acceptability

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

  10 weeks

• Post-Treatment Effects (Parent): Stress

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

  10 weeks

• Post-Treatment Effects (Parent): Optimism

  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.

  10 weeks

• Post-Treatment Effects (Child): Academics

  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.

  10 weeks

• Post-Treatment Effects (Child): Behavior

  To examine changes in child behavior the Conners-EC Rating Scale (R=0-100, higher scores indicate worse outcomes except for the developmental milestones)

  10 weeks

• Post-Treatment Effects (Child): Behavior Observations

  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)

  10 weeks

• Post-Treatment Effects (Child): Self Regulation

  To examine changes in child self-regulation, the Head-Toes-Knees-Shoulders-Task (R=0-16; higher scores indicate better outcomes)

  10 weeks

• Post-Treatment Effects (Child): Bedtime Behaviors

  To examine changes in child bedtime behaviors behaviors the Children's Sleep-Wake Scale-GTBS (R=5-30; higher scores indicate better outcomes).

  10 weeks

• Post-Treatment Effects (Child): Social Behaviors

  To assess changes in child social behaviors the Adaptive Social Behavior Inventory (R=30-90; higher scores indicate worse outcomes) will be used

  10 weeks

• Post-Treatment Effects (Child): Social Behaviors

  To assess maintenance in child social behaviors the Adaptive Social Behavior Inventory (R=30-90; higher scores indicate worse outcomes) will be used

  2 years

• Maintenance (Child): Behavior Observations

  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)

  2 years

• Maintenance (Child): Self Regulation

  To examine maintenance in child self-regulation, the Head-Toes-Knees-Shoulders-Task (R=0-16; higher scores indicate better outcomes)

  2 years

• Maintenance (Child): Bedtime Behaviors

  To examine maintenance in child bedtime behaviors behaviors the Children's Sleep-Wake Scale-GTBS (R=5-30; higher scores indicate better outcomes).

  2 years

• Maintenance (Parent): Acceptability

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

  2 years

• Maintenance (Parent): Behavior

  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)

  2 years

• Maintenance (Parent): Intervention Strategies

  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).

  2 years

• Maintenance (Parent): Stress

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

  2 years

• Maintenance (Parent): Optimism

  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.

  2 years

• Mediators and Moderators (Parent): Session Completion

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

  2 years

• Mediators and Moderators (Parent): Demographics

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

  2 years

• Mediators and Moderators (Parent): ADHD Symptoms

  Parent ADHD symptoms will be assessed using the Adult Investigator Symptom Rating Scale (R=18-90; higher scores= worse outcomes).

  2 years

• Mediators and Moderators (Parent): Parent Strategies

  The test of parent knowledge (R= 0-15) and fidelity checklist (R= 0-9) (higher scores = better outcomes) will be used.

  2 years

• Mediators and Moderators (Parent): Stress

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

  2 years

• Mediators and Moderators (Parent): Media

  Parent media use preference the Media and Technology Usage and Attitudes Scale (MTUAS) (R=45-506; higher scores = better outcomes) will be used.

  2 years

• Mediators and Moderators (Child)

  To assess child self regulation the Head-Toes-Knees-Shoulders-Task (HTSK) will be used (R=0-16; higher scores indicate better outcomes).

  2 years

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

  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).

  5 years

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

  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).

  5 years

• Cost-Effectiveness (time): Online

  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).

  5 years

• Cost-Effectiveness (money): Online

  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).

  5 years

Study Arms (3)

Face to Face Treatment

EXPERIMENTAL

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.

Behavioral: Promoting Engagement with ADHD Pre-Kindergarteners

Online Treatment

EXPERIMENTAL

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.

Behavioral: Promoting Engagement with ADHD Pre-Kindergarteners

Waitlist Control

OTHER

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.

Behavioral: Promoting Engagement with ADHD Pre-Kindergarteners

Interventions

Promoting Engagement with ADHD Pre-Kindergarteners BEHAVIORAL

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

Also known as: PEAK, Optimism Training

Face to Face Treatment; Online Treatment; Waitlist Control

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lehigh University: lead
• Institute of Education Sciences: collaborator

Study Sites (1)

Lehigh University

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Child Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• George J DuPaul, Ph.D.

  Lehigh University

  PRINCIPAL INVESTIGATOR

• Lee Kern, Ph.D.

  Lehigh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George J DuPaul, Ph.D.

CONTACT

6107583252; gjd3@lehigh.edu

Lee Kern, Ph.D.

CONTACT

610-758-3267; lek6@lehigh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research; Professor of School Psychology

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 13, 2020
• Study Start: September 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)