I-InTERACT Preterm

Pre-Term Clinical Trial

Official title: I-InTERACT Preterm

Status Active, not recruiting

Clinical Trial Summary

Open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (< 32 weeks gestational age). Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later.

Clinical Trial Description

The investigators will modify I-InTERACT North to reflect United States language and culture and emphasize our focus on neural plasticity and development. The modified intervention will be renamed Building Better Brains and Behavior (B4 Preterm). Then, investigators will conduct a single-arm clinical trial to establish B4 Preterm's feasibility, acceptability and preliminary efficacy in improving child and family outcomes. Additionally, neuroimaging (MRI/DTI) will be collected pre- and post-intervention. The primary neuroimaging sequence will allow the investigators to examine associations between white matter injury and treatment response as well as changes in neural activation and connectivity pre- to post-treatment. An exploratory neuroimaging sequence will also be collected pre- and post-intervention. This exploratory sequence will serve as a backup for the primary sequence in case it is affected by significant motion and allow the investigators to test this sequence in young children. ;

Related Conditions & MeSH terms

• Pre-Term
• Premature Birth

• NCT number: NCT05282628
• Study type: Interventional
• Source: Children's Hospital Medical Center, Cincinnati
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2021
• Completion date: August 31, 2026