Actively Recruiting

Phase Not Applicable
Age: 3Years - 8Years
All Genders
Healthy Volunteers
ID06767293

I-InTERACT Preterm Parenting Randomized Controlled Trial Comparing I2P, I2P-Micro, and Internet Resources for Parents of Preterm Children

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-02-09

90

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Many children born very or extremely preterm face challenges with behavior, attention, social, and emotional skills. These children are more likely to develop ADHD and show related behavioral problems. Existing support for parenting these children is limited. Past research showed that the seven-session I-Interact Preterm (I2P) program helped reduce child behavior problems and improved positive parenting skills. This study aims to compare the original I2P program, a new microlearning version (I2P-Micro), and an internet resource group to see which best supports parents and children. The study will randomly assign participants to one of three groups: the seven-session I2P program with weekly therapist coaching, the I2P-Micro program delivering short online sessions with coaching, or an internet resource comparison group. Both intervention groups will meet weekly or every two weeks with a trained therapist to review content and practice skills. The study includes assessments before treatment, 12 weeks after starting, and at a six-month follow-up. Participants will engage in online learning and coaching sessions designed to improve parenting behaviors and reduce child behavior problems and parent distress. Researchers will evaluate parenting skills, child behavior using standardized checklists, and caregiver distress at 3 and 6 months after baseline. The trial is double-blind and randomized, with a total participation duration of about six months after starting treatment.

CONDITIONS

Brief Title

I-InTERACT Preterm Parenting

Who Can Participate

Age: 3Years - 8Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child born before 32 weeks gestational age
  • Child aged between 3 and 8 years
  • Child has a Total T score above 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR above 55 on the Eyberg Child Behavior Inventory total problem or intensity scale
  • English is the primary language spoken at home
  • Caregiver is aged 18 years or older
  • Child resides with caregiver at least half the time in a stable caregiving situation
Not Eligible

You will not qualify if you...

  • Caregiver is under 18 years old
  • Child does not live with the caregiver at least half-time or caregiving situation is unstable (e.g., scheduled custody hearings)
  • English is not the primary language spoken at home
  • Caregiver had a psychiatric hospitalization in the past year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants complete either the seven-session I-InTERACT Parenting Intervention, the microlearning I-InTERACT Parenting Intervention, or access internet resources. Those in the I2P and I2P-Micro groups meet weekly or biweekly with a therapist for coaching while practicing skills.

Weekly or biweekly coaching sessions

Follow-up

Duration - Approximately 3 months after treatment ends

Participants are assessed for parenting behaviors, child behavior problems, and parent distress six months after randomization.

1 follow-up visit

Trial Site Locations

Total: 1 location

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

S

Shari Wade, PhD

K

Kaylen McCullough, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Efficacy of the Incredible Years Programme as an early intervention for children with conduct problems and ADHD: long-term follow-up.

K Jones, D Daley, J Hutchings...

https://pubmed.ncbi.nlm.nih.gov/18410644

Understanding Early Childhood Resilience Following Neonatal Brain Injury From Parents' Perspectives Using a Mixed-Method Design.

Tricia S Williams, Kyla P McDonald, Samantha D Roberts...

https://pubmed.ncbi.nlm.nih.gov/31050330