- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417930
Hybrid Delivery to Increase Access and Sustainability: Evaluating ezParent Implementation (ezParent FT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Positive parenting practices (e.g., supportive, consistent, responsive) buffer the negative effects of early adverse experiences by developing safe, stable, and nurturing environments. Positive parenting practices are important in strengthening and creating positive childhood and supporting optimal child social and behavioral development. Parent training (PT) is the gold standard for supporting and strengthening parenting practices and preventing and treating child behavior problems. The PT program proposed in this study is the web-based adaptation of the evidence-based based Chicago Parent Program (CPP), called ezParent. The purpose of this study is to test the effects of hybrid delivery of ezParent versus a waitlist control on parent and child outcomes. Hybrid ezParent combines the self-administered ezParent with virtual or in-person group meetings. Hybrid ezParent lasts ~ 8 weeks and includes four 1-1.5 hour group sessions led by trained facilitators, held via Zoom or in person. Facilitators follow a discussion guide to reinforce content, build community, and support program use.
A cluster-randomized trial will be conducted with 16 organizations (sites) randomized to either the intervention (hybrid ezParent) or control condition (waitlist control). There will be 8 sites per condition. Each site will recruit approximately 32 parents of children aged 2-5 years, for a total sample size of approximately 516 parents. All participating parents within a given site will receive the condition assigned to that site. Once sites are randomized to intervention or waitlist control, parents are invited to participate through recruitment materials. Outcome data will be collected from parents at 3 timepoints over 6 months at baseline, and 10 and 24- weeks post-baseline. Outcome data includes parenting skills and self-efficacy, parent-child relationship, and reductions in child behavior problems.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susan M Breitenstein, PhD
- Phone Number: 614-688-4614
- Email: breitenstein.5@osu.edu
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Contact:
- Susan M Breitenstein, PhD
- Phone Number: 614-688-4614
- Email: breitenstein.5@osu.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent or legal guardian of a 2-5-year-old child receiving services at the partnering organization site.
- Speaks English.
- Has a smartphone, tablet, or computer with Wi-Fi access to receive the ezParent program.
Exclusion Criteria:
• Parents who have previously participated in CPP or ezParent will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Participants receive usual services for parents and families at their agency during the study period.
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Experimental: Hybrid ezParent Intervention
Hybrid ezParent includes the web-based ezParent program and 4 synchronous group sessions. ezParent is a 6-module digital delivery of the group-based Chicago Parent Program (CPP). The purpose of the program is to strengthen parenting, decrease child behavior problems, and increase child prosocial behavior. Each module includes: a video narrator describing parenting strategies; video vignettes of parents and children as examples of how parenting strategies work; questions following each vignette for parents to reflect upon; interactive activities for parents to complete; knowledge questions to assess parent understanding of the strategies; and practice assignments. Parents are instructed to complete modules independently between synchronous group sessions. Group sessions are 1-1.5 hours and follow a discussion guide to reinforce key content, build community, and support parents in using ezParent. Trained facilitators lead groups of about 10 parents either in-person or virtual. |
Hybrid ezParent includes the web-based ezParent program and 4 synchronous group sessions.
ezParent is a 6-module digital delivery of the group-based Chicago Parent Program (CPP).
The purpose of the program is to strengthen parenting, decrease child behavior problems, and increase child prosocial behavior.
Each module includes: a video narrator describing parenting strategies; video vignettes of parents and children as examples of how parenting strategies work; questions following each vignette for parents to reflect upon; interactive activities for parents to complete; knowledge questions to assess parent understanding of the strategies; and practice assignments.
Parents are instructed to complete modules independently between synchronous group sessions.
Group sessions are 1-1.5 hours and follow a discussion guide to reinforce key content, build community, and support parents in using ezParent.
Trained facilitators lead groups of about 10 parents either in-person or virtual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Multidimensional Assessment of Parenting Scale (MAPS) Parent-form - Version 2.0
Time Frame: Baseline, 10- and 24-weeks post-baseline
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A 35-item scale measures parenting practices constituting both positive and negative dimensions of warmth/hostility and behavioral control appropriate for parents of children across the developmental span from young childhood through adolescence.
Parents respond to each item on a 5-point scale from "Never" to "Always".
Possible range= 0-175
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Baseline, 10- and 24-weeks post-baseline
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Child-Parent Relationship Scale-Short Form (CPRS-SF)
Time Frame: Baseline, 10- and 24-weeks post-baseline
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The CPRS-SF has 15 items that parents rate their perception of their relationship with their child.
The measure taps into positive and negative aspects of parent-child relationships.
The CPRS-SF is rated on a 5-point scale with two subscales of closeness and conflict.
Possible range= 0-35
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Baseline, 10- and 24-weeks post-baseline
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Parenting Sense of Competence Scale (PSOC)
Time Frame: Baseline, 10- and 24-weeks post-baseline
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The Parenting Sense of Competence Scale (PSOC) has 17 items, with 2 subscales: satisfaction (person's liking of the parenting role) and efficacy (person's perceived competence in the parenting role). Scale: 6-point Likert scale (1 = strongly disagree, 6 = strongly agree) Minimum item score = 1 Maximum item score = 6 Subscale scoring (satisfaction and efficacy): Higher scores means a better outcome |
Baseline, 10- and 24-weeks post-baseline
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Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Baseline, 10- and 24-weeks post-baseline
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The Strengths and Difficulties Questionnaire (SDQ) is 25-items with five subscales: emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. A total difficulties score (TDS) is generated from the emotional, conduct, hyperactivity- inattention, and peer problems scales. Scale: 3-point scale (not true, somewhat true, and certainly true). Minimum item score = 0 Maximum item score = 2 Minimum subscale score = 0 Maximum subscale score = 10 Subscale scoring - Prosocial subscale: Higher score means a better outcome All other subscales (emotional, conduct, hyperactivity, peer): Higher scores means a worse outcome |
Baseline, 10- and 24-weeks post-baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 0352
- 1R42HD116627-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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