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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Parent-Child Relations

Clinical Trials on I-InTERACT Parenting Intervention (I2P) and coaching sessions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings