Intervention for parents of very preterm children to improve behavior
I-InTERACT Preterm Parenting Randomized Controlled Trial
This study is testing two different parenting programs to see if they can help parents of very preterm children improve their parenting skills and reduce behavior problems in their kids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06767293 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the I-Interact Preterm Parenting intervention (I2P) and a microlearning version (I2P-Micro) in improving parenting behaviors and reducing child behavior problems in children born very preterm. The study involves a three-arm randomized controlled trial comparing the established I2P program, the microlearning approach, and an internet resource comparison group. Outcomes will be assessed at three time points: before treatment, 12 weeks post-treatment, and six months after randomization, focusing on parenting behaviors, child behavior issues, and parent distress. The trial aims to determine if the microlearning format enhances engagement and effectiveness compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates for this study are caregivers of children born at less than 32 weeks gestational age who exhibit behavioral problems.
Not a fit: Patients who may not benefit include those whose primary language is not English or who have unstable caregiving situations.
Why it matters
Potential benefit: If successful, this intervention could significantly improve parenting skills and reduce behavioral problems in children born very preterm.
How similar studies have performed: Previous pilot trials have shown promising results for similar interventions, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Shari Wade, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Shari Wade, PhD
- Email: shari.wade@cchmc.org
- Phone: 5134610952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.