I-InTERACT Preterm Parenting (NCT06767293)
I-InTERACT Preterm Parenting Randomized Controlled Trial
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cincinnati Children's Hospital Medical Center โ Cincinnati, Ohio
Age range: 3 Years to 8 Years
๐งช Interventions in This Study
- I-InTERACT Parenting Intervention (I2P) and coaching sessions (BEHAVIORAL)
- I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions (BEHAVIORAL)
- Internet Resources (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Cincinnati Children's Hospital Medical Center โ Cincinnati, Ohio
๐ Contact the Study Coordinator
Phone: (513) 461-0952
Email: shari.wade@cchmc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.