I-InTERACT Preterm Parenting

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06767293
Status
Recruiting
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Conditions

  • Child Behavior Problem
  • Parent-Child Relations
  • Parenting
  • Preterm

Eligibility Criteria

Sex
ALL
Age
3 Years - 8 Years
Healthy Volunteers
Accepted

Interventions

  • I-InTERACT Parenting Intervention (I2P) and coaching sessions — BEHAVIORAL
    Online learning sessions for parents of preterm children
  • I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions — BEHAVIORAL
    Online microlearning sessions for parents of preterm children
  • Internet Resources — OTHER
    control condition

Study Details

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.

Key Dates

Start date
Nov 27, 2024
Status verified
Feb 2026
Primary completion
Oct 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Shari Wade, PhD
[email protected]
5138034737
Kaylen McCullough, BS
[email protected]
8595336164
Shari Wade, PhD (PRINCIPAL_INVESTIGATOR)

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