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NCT05217615 · ClinicalTrials.gov registry record · NA
Parent Training for Parents of Toddlers Born Very Premature:
A NA study of Parenting and Premature Birth, sponsored by Ohio State University.
- Active
- Registry status
- NA
- Development phase
- 490
- Enrollment target
- 3
- Study locations
NCT05217615: Active NA study of Parenting and Premature Birth, sponsored by Ohio State University.
NCT05217615 is a NA study of Parenting and Premature Birth that is active but no longer recruiting, run by Ohio State University. The registered enrollment target is 490 participants, below the 641-participant average among 66 other Parenting trials with a reported enrollment target (24% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05217615, a NA study of Parenting and Premature Birth, is active but no longer recruiting, sponsored by Ohio State University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 490 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
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). Scoring is on a 6-point scale (1 = strongly disagree to 6 = strongly agree). Higher scores indicate a better outcome (higher perceived parenting satisfaction and efficacy). The PSOC is correlated with other measures of family life and child behavior, and the satisfaction subscale is strongly correla
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 |
What the registry record for NCT05217615 still lists
NCT05217615 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, below the 641-participant average among 66 other Parenting trials with a reported enrollment target (24% lower).
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.
NCT05217615 reports a single indexed study location in Ohio, Illinois.
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.
What interventions are being tested in trial NCT05217615?
The interventions under investigation include: Active Control (BEHAVIORAL), Coaching calls (BEHAVIORAL), ezParent (BEHAVIORAL).
Who is sponsoring clinical trial NCT05217615?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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