RecruitingNot ApplicableNCT06767293

I-InTERACT Preterm Parenting

I-InTERACT Preterm Parenting Randomized Controlled Trial


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

90 participants

Start Date

Nov 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 8 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

BEHAVIORALI-InTERACT Parenting Intervention (I2P) and coaching sessions

Online learning sessions for parents of preterm children

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

Online microlearning sessions for parents of preterm children

OTHERInternet Resources

control condition


Locations(1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT06767293


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