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I-InTERACT Preterm Parenting

NCT06767293 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-02-09

No results posted yet for this study

Summary

Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.

Conditions

  • Child Behavior Problem
  • Preterm
  • Parent-Child Relations
  • Parenting

Interventions

BEHAVIORAL

I-InTERACT Parenting Intervention (I2P) and coaching sessions

Online learning sessions for parents of preterm children

BEHAVIORAL

I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions

Online microlearning sessions for parents of preterm children

OTHER

Internet Resources

control condition

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Shari Wade, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-27
Primary Completion
2026-10-30
Completion
2027-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06767293 on ClinicalTrials.gov