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Behavioral Intervention

Building Better Brains and Behavior program (B4 Preterm) for Preterm Birth

N/A
Waitlist Available
Led By Shari L Wade, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age at enrollment: ages 3-8, inclusive
Born at < 32 weeks gestational age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 10
Awards & highlights

Study Summary

This trial is testing a parenting intervention for young children who were born very preterm. Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed before and after the intervention.

Who is the study for?
This trial is for children aged 3-8 who were born very preterm (before 32 weeks of pregnancy) and are experiencing behavioral problems. The child must live with a caregiver over 18 years old, primarily speak English at home, and have no unstable caregiving situations or recent psychiatric hospitalizations in the family.Check my eligibility
What is being tested?
The 'Building Better Brains and Behavior program' (B4 Preterm), an online parenting-skills course, is being tested to see if it improves parent-child interactions, child behavior, parental functioning, and brain connectivity in very preterm children.See study design
What are the potential side effects?
Since this intervention involves educational material rather than medication, traditional side effects are not expected. However, there may be indirect effects on family dynamics as behaviors change.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between the ages of 3 and 8.
Select...
I was born before 32 weeks of pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Childhood Experiences Scales (ACES)
Behavior Rating Inventory of Executive Functions-2
Center for Epidemiologic Studies Depression Scale (CES-D)
+5 more
Secondary outcome measures
3D T2- weighted sequence
3D-T1 weighted sequences
Multi-shell diffusion sequence
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Building Better Brains and Behavior program (B4 Preterm)Experimental Treatment1 Intervention
Online learning modules completed sequentially and in conjunction with live coaching sessions led by a trained therapist.

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Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,572 Total Patients Enrolled
Shari L Wade, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
3 Previous Clinical Trials
159 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
I-InTERACT Preterm
2021. "I-InTERACT Preterm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05282628.
~9 spots leftby Aug 2026
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