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Parent Training for Premature Birth Outcomes (ezParent Trial)

N/A

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; 3-month, 6-month, 12-month post-baseline

Awards & highlights

ezParent Trial Summary

This trial is testing whether a web-based parent training program called ezParent, with or without coaching calls, is effective in improving parent and child outcomes.

Who is the study for?

This trial is for English-speaking parents or guardians of very preterm toddlers (born before 32 weeks gestation) aged between 20-30 months, who have access to a smartphone, tablet, or computer with Wi-Fi. Children with profound developmental impairments as measured by the Vineland Scale are not eligible.Check my eligibility

What is being tested?

The study tests a web-based parent training program called ezParent and telephone coaching calls on improving parenting skills and child behavior. Parents will be randomly assigned to one of four groups: ezParent with coach, just ezParent, Active Control with coach, or just Active Control.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medical treatments, traditional physical side effects are not applicable. However, participants may experience varying levels of stress or emotional discomfort during the training.

ezParent Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; 3-month, 6-month, 12-month post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; 3-month, 6-month, 12-month post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 3-month, 6-month, 12-month post-baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Child Behavior (Child Behavior Checklist 1½-5 (CBCL))

Change in Child Behavior (Eyberg Child Behavior Inventory (ECBI))

Change in Parenting Behaviors (Parent Questionnaire (PQ))

+4 more

Secondary outcome measures

Intervention engagement

Parent engagement - coaching calls

Program satisfaction

Other outcome measures

Confusion, Hubbub, and Order Scale (CHAOS)

General Demographics and Income

Neighborhood and community characteristics

+2 more

ezParent Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: ezParent+ coachExperimental Treatment2 Interventions

ezParent - Program is a 6-module digital adaptation of the group-based Chicago Parent Program, 12-session program for parents of young children. A core objective of the CPP is to promote positive parenting behavior - for example, teaching parents to limit the amount of attention given to negative behaviors and reward the positive - to decrease child behavior problems and increase child prosocial behavior. Coach - The purpose of the brief weekly telephone coaching calls is to provide parents with an opportunity to receive clarification of intervention content, encouragement and reinforcement of intervention completion, and support tailoring of intervention content for their child. The coaching calls will be guided by a semi-structured script aimed at supporting parent learning and motivation. Coaches will be trained in active and empathic listening and problem solving techniques to facilitate learning and support of parents.

Group II: ezParentExperimental Treatment1 Intervention

Group III: Active Control+coachActive Control2 Interventions

Active Control - The active control is an adaptation of a digital application used in our previous study (HS024273). The program will include general information typically provided during well-child or NICU follow up visits but unrelated to parenting or child development and behavior. Six topic areas are: Immunizations, Common Childhood Illnesses, Nutrition, Dental Health, and Indoor and Outdoor Injury Prevention/Safety. The program includes digital handouts, websites, and resources provided to parents of children in this age group. Coach - The purpose of the brief weekly telephone coaching calls is to provide parents with an opportunity to receive clarification of intervention content, encouragement and reinforcement of intervention completion, and support tailoring of intervention content for their child. The coaching calls will be guided by a semi-structured script aimed at supporting parent learning and motivation.

Group IV: Active ControlPlacebo Group1 Intervention

The active control is an adaptation of a digital application used in our previous study (HS024273). The program will include general information typically provided during well-child or NICU follow up visits but unrelated to parenting or child development and behavior. Six topic areas are: Immunizations, Common Childhood Illnesses, Nutrition, Dental Health, and Indoor and Outdoor Injury Prevention/Safety. The program includes digital handouts, websites, and resources provided to parents of children in this age group. Parents will be instructed to review each topic over 10-weeks (~1 topic every 1.5 weeks) to match the dose and timing of contact that the intervention groups will receive.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

828 Previous Clinical Trials

505,261 Total Patients Enrolled

6 Trials studying Premature Birth

2,557 Patients Enrolled for Premature Birth

Rush University Medical CenterOTHER

422 Previous Clinical Trials

163,041 Total Patients Enrolled

1 Trials studying Premature Birth

611 Patients Enrolled for Premature Birth

Nationwide Children's HospitalOTHER

341 Previous Clinical Trials

5,220,013 Total Patients Enrolled

8 Trials studying Premature Birth

7,035 Patients Enrolled for Premature Birth

Media Library

ezParent Clinical Trial Eligibility Overview. Trial Name: NCT05217615 — N/A

Premature Birth Research Study Groups: ezParent+ coach, Active Control, ezParent, Active Control+coach

Premature Birth Clinical Trial 2023: ezParent Highlights & Side Effects. Trial Name: NCT05217615 — N/A

ezParent 2023 Treatment Timeline for Medical Study. Trial Name: NCT05217615 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for participants in this clinical experiment?

"Affirmative. Data found on clinicaltrials.gov reveals that this medical study, which was initially posted in August 3rd 2022 is presently enrolling patients. Approximately 490 people will be solicited from 3 distinct research centres."

Answered by AI

How many participants are taking part in this research endeavor?

"Affirmative, the clinicaltrials.gov website implies that this trial is enrolling participants at present time; it was announced on August 3rd 2022 and revised on September 30th 2022. A total of 490 patients are sought from a trio of locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Parent Training for Parents of Toddlers Born Very Premature:

Susie Breitenstein 2022. "Parent Training for Parents of Toddlers Born Very Premature:". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05217615.