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OpenTrials
Active, Not Recruiting

NCT Number: NCT05689736

Optimizing an Evidence-Based, Disseminable, Free Internet-Based Parenting Program

The CDC's Essentials for Parenting Toddlers and Preschoolers program (EFP) is a free Internet resource with the potential to break down barriers to population-wide access to scientifically-based parenting interventions. EFP has considerable promise, but parental engagement, a major issue in the success of universal parenting interventions, remains a challenge. The objective of the proposed research is to optimize EFP by identifying engagement-focused intervention elements to add to EFP that enhance its effects on parenting skills.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westat, Inc.

Rockville, Maryland, 20850, United States

About this study

The study is a longitudinal factorial optimization trial in a community sample of 800 parents with 1.5- to 3-year-old children. There are 4 experimental factors; each corresponds to the presence vs. absence of an engagement-focused intervention element. This experiment enables the estimation of the individual and combined effects of each element. The specific aims follow.

Aim 1: Optimize the effects of EFP on parenting skills by determining which combination of the four experimental engagement-focused intervention elements results in the greatest success of EFP, as reflected in increasing parent warmth and reducing corporal punishment, overreactive and lax discipline.

Aim 2: Determine the extent to which boosted meaningful parent engagement in EFP is the mechanism driving the effects of the four engagement-focused intervention elements on parenting skills, and which aspect(s) of engagement (e.g., content consumption; behavioral skills practice) are the key mediators that translate the effects of the four engagement-focused intervention elements into improved parenting.

Aim 3: Examine parent (e.g., change readiness; race) and child characteristics (e.g., externalizing behavior; sex) to determine if the optimal intervention package differs among subgroups. Cracking the code of providing parents with an intervention that they actually use, and that improves parenting, could have far-reaching effects (e.g., improving population-level child outcomes).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18- to 36-month-old child
  • ≥18-year-old parent
  • Internet access
  • willingness to commit to intervention/assessment procedures
  • proficiency in speaking and reading English

Exclusion criteria

  • child older than 36 months
  • parent younger than 18 years
  • no access to internet
  • not willing to commit to intervention/assessment procedures OR
  • not proficient with speaking and reading English

Treatment and study plan

Motivational Enhancement

Behavioral

Motivational Enhancements (ME) will include three features:

  • Personalized change plan. Parents will describe their intervention goals, motivation for participation, steps they are willing to take to meet those goals, as well as potential barriers to engagement and strategies to try to overcome such barriers. We will display the change plan to remind parents of their personalized responses. ME will also integrate participants' change plan responses into intervention content.
  • Assessment feedback. We will provide norm-referenced feedback for each selected parenting measure after the week 1 assessment. For simplicity, feedback will graphically categorize the parent or child in 3 categories per outcome: red (≥90th %ile), yellow (70-89th %ile), and green (<70th %ile).
  • Modified, personalized SMS text nudges. Parents will receive 2 weekly personalized SMS messages based on their change plan responses.

Simplification

Behavioral

We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement.

Gamification

Behavioral

Gamification will include four features:

  • Game-like graphical environment (e.g., avatars to represent the participant).
  • Digital rewards. Parents will receive points and badges for completing intervention activities.
  • Leaderboard. A leaderboard will be used to activate competitive motives and social referencing. The leaderboard will display the points/badges of the participant relative to 4 other actual or simulated anonymized parents who are at a similar point in the intervention; their number of points and badges will be determined by those of the participant.
  • Modified, personalized SMS text nudges. SMS text nudges will alternate between Core content (e.g., reminder to complete a module) and reminders about game features such as badges and standings.

Low Engagement Nudges

Behavioral

SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module.

Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Behavioral

All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules.

All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting.

Primary outcomes

  1. Parent Behavior Inventory, item average of Supportive/Engaged subscale

    Time frame: 6 months

    Parental warmth (e.g., physical affection) will be measured by parent completing the 10-item self-report Supportive Engaged subscale of the Parent Behavior Inventory.

  2. Parent-Child Conflict Tactics Scale, item average of Corporal Punishment subscale

    Time frame: 6 months

    Corporal punishment (noninjurious physical discipline, e.g., spanking) will be measured by parent completing the 6-item self-report corporal punishment subscale of the Parent-Child Conflict Tactics Scale

  3. Parenting Scale, item average of Overreactivity subscale

    Time frame: 6 months

    Parents' use of harsh or otherwise overreactive discipline (i.e., angry discipline) will be measured by parent completing the 10-item self-report Overreactivity subscale of the Parenting Scale.

  4. Parenting Scale, item average of Laxness subscale

    Time frame: 6 months

    Use of permissive or lax discipline (e.g., failure to enforce rules) will be measured by parent completing the 11-item self-report Laxness subscale of the Parenting Scale

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Westat

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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