Optimizing an Evidence-Based, Disseminable, Free Internet-Based Parenting Program
Study Overview
Status
Conditions
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Rockville, Maryland, United States, 20850
- Westat, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motivational Enhancements + Simplification + Gamification + Low Engagement Nudge
Participants will receive the Core Essentials for Parenting (EFP) intervention and all additional engagement-focused intervention elements: motivational enhancements, simplification, gamification, and low engagement nudges.
|
Motivational Enhancements (ME) will include three features:
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 will include four features:
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.
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. |
|
Experimental: Motivational Enhancements + Simplification + Gamification
Participants will receive the Core EFP intervention and motivational enhancement, simplification, and gamification intervention elements.
|
Motivational Enhancements (ME) will include three features:
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 will include four features:
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. |
|
Experimental: Motivational Enhancements + Simplification + Low Engagement Nudge
Participants will receive the Core EFP intervention and motivational enhancement, simplification, and low engagement nudges as intervention elements.
|
Motivational Enhancements (ME) will include three features:
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.
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.
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. |
|
Experimental: Motivational Enhancements + Simplification
Participants will receive the Core EFP intervention and motivational enhancement and simplification as intervention elements.
|
Motivational Enhancements (ME) will include three features:
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.
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. |
|
Experimental: Motivational Enhancements + Gamification + Low Engagement Nudge
Participants will receive the Core EFP intervention and motivational enhancement, gamification, and low engagement nudge as intervention elements.
|
Motivational Enhancements (ME) will include three features:
Gamification will include four features:
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.
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. |
|
Experimental: Motivational Enhancements + Gamification
Participants will receive the Core EFP intervention and motivational enhancement and gamification as intervention elements.
|
Motivational Enhancements (ME) will include three features:
Gamification will include four features:
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. |
|
Experimental: Motivational Enhancements + Low Engagement Nudge
Participants will receive the Core EFP intervention and motivational enhancement and low engagement nudge as intervention elements.
|
Motivational Enhancements (ME) will include three features:
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.
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. |
|
Experimental: Motivational Enhancements
Participants will receive the Core EFP intervention and motivational enhancement as an additional intervention element.
|
Motivational Enhancements (ME) will include three features:
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. |
|
Experimental: Simplification + Gamification + Low Engagement Nudge
Participants will receive the Core EFP intervention and simplification, gamification, and low engagement nudge as additional intervention elements.
|
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 will include four features:
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.
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. |
|
Experimental: Simplification + Gamification
Participants will receive the Core EFP intervention and simplification and gamification as additional intervention elements.
|
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 will include four features:
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. |
|
Experimental: Simplification + Low Engagement Nudge
Participants will receive the Core EFP intervention and simplification and low engagement nudge as intervention elements.
|
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.
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.
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. |
|
Experimental: Simplification
Participants will receive the Core EFP intervention and simplification as an additional intervention element.
|
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.
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. |
|
Experimental: Gamification + Low Engagement Nudge
Participants will receive the Core EFP intervention and gamification and low engagement nudge as additional intervention elements.
|
Gamification will include four features:
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.
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. |
|
Experimental: Gamification
Participants will view the Core EFP and will be exposed only to gamification as an additional intervention element.
|
Gamification will include four features:
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. |
|
Experimental: Low Engagement Nudge
Participants will receive the Core EFP intervention and low engagement nudge as an additional intervention element.
|
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.
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. |
|
Experimental: EFP Only
Participants will receive the Core EFP intervention and not be exposed to any additional intervention elements.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
|
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
|
6 months
|
|
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.
|
6 months
|
|
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
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kimberly Rhoades, Ph.D., New York University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R01HD101634 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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