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Parent Training for Parents of Toddlers Born Very Premature:
NCT05217615 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the study is to test the effects of the ezParent (web-based parent training program) intervention and telephone coaching calls (coach) on parent and child outcomes after 3-, 6-, and 12-months. Parents (n=220) will be randomized using a 2 x 2 factorial design to: (1) ezParent+coach, (2) ezParent, (3) Active Control+coach, or (4) Active control. The investigators will address these aims: 1. Determine the independent and combined effects of ezParent and coaching calls on parent outcomes. H1: The ezParent and ezParent+coach groups will report greater improvements in parenting skills and self-efficacy and reductions in harsh and negative discipline; and exhibit observed improvements in parent-child emotional connection vs. active control H2: There will be a synergistic effect of ezParent and coaching calls on parent outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls. 2. Determine the independent and combined effects of ezParent and coaching calls on child outcomes. H3: The ezParent and ezParent+coach groups will report greater reductions in child behavior problems vs. active control. H4: There will be a synergistic effect of ezParent and coaching calls on child outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls. 3. Determine differences in ezParent engagement with and without coaching calls. Engagement will be assessed by frequency (the number of times parents use the program), activity (proportion of material completed), and duration (amount of time parents use the program). H5: Relative to the ezParent only group, the ezParent+coach group will exhibit higher engagement with the ezParent.
Conditions Studied
Interventions
- BEHAVIORAL Active Control
- BEHAVIORAL Coaching calls
- BEHAVIORAL ezParent
Study Locations (3)
Ohio
- Nationwide Children's Hospital — Columbus
- Ohio State University College of Nursing — Columbus
Illinois
- Rush University Children's Hospital — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2022-08-03 |
| Est. Completion | 2026-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05217615
The ClinicalTrials.gov registry entry for NCT05217615 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 490 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 640 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Parenting appearing as the primary indexed condition, and to 3 interventions — of which Active Control is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05217615 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Ohio, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05217615 about?
NCT05217615 is a clinical study titled "Parent Training for Parents of Toddlers Born Very Premature:". The purpose of the study is to test the effects of the ezParent (web-based parent training program) intervention and telephone coaching calls (coach) on parent and child outcomes after 3-, 6-, and 12-months. Parents (n=220) will be randomized using a 2 x 2 factorial design to: (1) ezParent+coach, (2...
What is the current status of trial NCT05217615?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 490 participants. The study started on 2022-08-03. Estimated completion is 2026-04-01.
What conditions does trial NCT05217615 study?
This clinical trial studies the following conditions: Parenting, Premature Birth, Problem Behavior, Parenting Intervention. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05217615?
The interventions under investigation include: Active Control (BEHAVIORAL), Coaching calls (BEHAVIORAL), ezParent (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05217615?
This trial is sponsored by Ohio State University, which has 640 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05217615 being conducted?
This trial has 3 study locations across Illinois, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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