NCT05282628

I-InTERACT Preterm

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 36 Months – 96 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pre-Term

Interventions

Type	Name	Description
BEHAVIORAL	Building Better Brains and Behavior program (B4 Preterm)	The program couples online learning modules with video conferencing sessions with a trained therapist to review skills and practice implementing the skills with live coaching. Online modules include didactic content, video clips of parents modeling the skills, and exercises. Parents will complete intervention modules sequentially in conjunction with scheduled 1:1 videoconference sessions with a trained therapist. Videoconference sessions with the therapist will be scheduled weekly, once parents have completed their modules. During these sessions, the therapist will review the online materials and provide active coaching to the parent on how to use the skills with their child (e.g., labeled praise, reflective responses). Each session follows a manualized therapy protocol to optimize content fidelity. Parents will be instructed to practice the parenting skills for 5 minutes each day to promote mastery in the home environment.

Timeline

• Start date: 2021-09-01
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2022-03-16
• Last updated: 2024-02-06

Locations

1 site across 1 country: United States