I-InTERACT Preterm Parenting (I2P-RCT)

February 5, 2026 updated by: Children's Hospital Medical Center, Cincinnati

I-InTERACT Preterm Parenting Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Many children born very preterm or extremely preterm exhibit a distinct behavioral phenotype characterized by impairments in cognition and attention and concomitant social and emotional problems. These children are significantly more likely to develop ADHD than children born at term and have similar rates of comorbid symptoms such as noncompliance, emotionality, and attention-seeking behaviors as those observed in children with ADHD. Although addressing children's mental health and behavioral challenges is a priority identified by parents, evidence-based interventions to promote effective parenting and mitigate child behavior problems in this population are lacking.

From 2021-2022, a single-arm pilot clinical trial was conducted for children born very preterm using content adapted from previous trials of I-InTERACT North and I-InTERACT Express, which included seven sessions and weekly online coaching from a therapist. Children demonstrated a significant reduction in externalizing behavior problems from pre- to post-intervention, and caregivers' positive parenting skills significantly increased during the same period.

Given relatively high rates of attrition in the pilot trial and stakeholder feedback regarding challenges in completing the program, the utility of microlearning delivery-delivering content in approximately 5-minute segments-will be tested relative to the existing I-InTERACT Preterm program and an internet resource comparison group. This approach is anticipated to improve uptake, engagement, and retention, particularly for young adults who routinely consume information in this format, while maintaining the efficacy of the original program.

A three-arm randomized controlled trial (RCT) is proposed to compare the seven-session I2P program to the microlearning delivery mode (I2P-Micro) and an internet resource comparison group (IRC). Participants in the I2P and I2P-Micro groups will also meet weekly or biweekly with a trained therapist to review content and receive coaching while practicing skills. 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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shari Wade, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Born at < 32 weeks gestational age.
  • Total T score of > 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR Total T score of > 55 on the Eyberg Child Behavior Inventory total problem- or total intensity-scale.
  • English is the primary spoken language in the home.

Exclusion Criteria:

  • Is not 18 years or older.
  • Participant will be excluded from the study if the child does not reside with the caregiver at least half-time; the caregiving situation is not stable (i.e., there must be no scheduled custody hearings).
  • English is not the primary language spoken in the home.
  • Caregivers with a psychiatric hospitalization in the past year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I-InTERACT Intervention (I2P) with regularly scheduled therapist coaching
Behavioral: I-InTERACT Parenting Intervention (I2P) and coaching sessions
Online learning sessions for parents of preterm children
Active Comparator: I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coaching
Behavioral: I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions
Online microlearning sessions for parents of preterm children
Other: Internet Resource Group
Control condition
Other: Internet Resources
control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score
Time Frame: 3 months post baseline and 6 months post baseline
Minimum score is 0, maximum score is not applicable as parents may exhibit any number of positive behaviors during the time frame data is collected. A higher score means a greater number of positive parenting behaviors were exhibited, which is considered better.
3 months post baseline and 6 months post baseline
Child Behavior Checklist Externalizing T-score
Time Frame: 3 months post baseline and 6 months post baseline
Minimum t score for girls is 33, and maximum t score is 100. Minimum t score for boys is 34 and maximum t score is 100. A higher t score indicates more externalizing behaviors, which is considered worse.
3 months post baseline and 6 months post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECBI Intensity T-Score
Time Frame: 3 months post baseline and 6 months post baseline
The ECBI Problem T-Score is a 36-item checklist of concerns (e.g., noncompliance, emotionality, attention-seeking) will be used to assess the number and intensity of child behavior problems pre- and post-treatment. On the ECBI, the parent rates how often each behavior occurs (7-point intensity scale), and whether the behavior is a problem (Yes/No Problem Scale). Higher T-Scores indicate greater intensity of problem behaviors. The lowest T-Score is 36 and the highest is 252, with a clinical cut-off at 60. During screening for this study, a T-Score greater than 55 for this scale meets meeting eligibility criteria.
3 months post baseline and 6 months post baseline
ECBI Problem T-Score
Time Frame: 3 months post baseline and 6 months post baseline
The ECBI Problem T-Score is a 36-item checklist of concerns (e.g., noncompliance, emotionality, attention-seeking) will be used to assess the number and intensity of child behavior problems pre- and post-treatment. On the ECBI, the parent rates how often each behavior occurs (7-point intensity scale), and whether the behavior is a problem (Yes/No Problem Scale). Higher T-Scores indicate more challenging behaviors. The lowest T-Score is 41 and the highest is 88, with a clinical cut-off at 60. During screening for this study, a T-Score greater than 55 for this scale meets meeting eligibility criteria.
3 months post baseline and 6 months post baseline
Caregiver Psychological Distress
Time Frame: 3 months post baseline and 6 months post baseline
Caregiver psychological distress will be assessed using the CES-D, a 20-item self-report inventory in which participants rate how often over the last week they have been bothered by various symptoms of depression in the last week. Total scores range from 0 to 60, with higher scores indicate greater caregiver distress. Scores 16 and above indicate a risk for clinical depression.
3 months post baseline and 6 months post baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Stress
Time Frame: 3 months post baseline and 6 months post baseline
The Parental Stress Scale attempts to measure the levels of stress experienced by parents through an 18-item self-report measure. Questions are answered on a 5-Point Likert scale. Higher scores indicate a higher level of parental stress. There are no clinical cut-offs.
3 months post baseline and 6 months post baseline
Positive Attitude Towards Child
Time Frame: 3 months post baseline and 6 months post baseline
Positive attitude towards the child will be measured using the Five-Minute Speech Sample (FMSS), which is a procedure designed to assess expressed emotion in caregivers by asking respondents to talk for five uninterrupted minutes about their thoughts and feelings about a subject and how they get along together. The speech sample is coded, with a greater number of positive responses coded indicating a greater positive attitude towards their child.
3 months post baseline and 6 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Shari Wade, PhD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only de-identified data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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