Recruiting

I2P, I2P-Micro, IRC

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06767293

Conditions

Child Behavior Problem

Preterm

Parent-Child Relations

Parenting

Eligibility Criteria

Sex: All

Age: 3 - 8

Healthy Volunteers: Accepted

Interventions

I-InTERACT Parenting Intervention (I2P) and coaching sessions

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

Internet Resources

Study Details

Brief 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

Study ID

NCT06767293

Start date

Nov 27, 2024

Status verified date

Feb, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 8

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: I-InTERACT Intervention (I2P) with regularly scheduled therapist coaching

active comparator: I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coaching

other: Internet Resource Group

Control condition

Interventions

I-InTERACT Parenting Intervention (I2P) and coaching sessions

Online learning sessions for parents of preterm children

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

Online microlearning sessions for parents of preterm children

Internet Resources

control condition

Primary outcome measure

  • Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Shari Wade, PhD

5134610952shari.wade@cchmc.org

Kaylen McCullough, BS

8595336164kaylen.mccullough@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Shari Wade, PhD

5138034737shari.wade@cchmc.org

Kaylen McCullough, BS

8595336164kaylen.mccullough@cchmc.org

Principal Investigator:

Shari Wade, PhD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • telehealth
  • online learning
  • microlearning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-02-09.