I-InTERACT Preterm

Not Applicable

Active, not recruiting

• Conditions: Pre-Term
• Interventions: Behavioral: Building Better Brains and Behavior program (B4 Preterm)

• Registration Number: NCT05282628
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Study Timeline

• Study First Submitted: 2021-08-31
• Study Start: 2021-09-01
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Age at enrollment: ages 3-8, inclusive
• 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 OR documented behavioral problems noted in medical chart and parent endorses current concerns about child's behaviors
• Language: English must be the primary spoken language in the home

Exclusion Criteria

Caregiver must be 18 years or older to participate in the intervention. 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. Additionally, caregivers with a psychiatric hospitalization in the past year will be ineligible to participate. Children with certain types of metal in their heads will be unable to participate in the MRI portion but will be able to participate in the intervention and complete pre- and post-intervention questionnaires.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Building Better Brains and Behavior program (B4 Preterm)	Building Better Brains and Behavior program (B4 Preterm)	Online learning modules completed sequentially and in conjunction with live coaching sessions led by a trained therapist.

Primary Outcome Measures

Name	Time	Method
Behavior Rating Inventory of Executive Functions-2	Week 10	Executive Function Behaviors
Eyberg Child Behavior Inventory (ECBI)	Week 10	Child Behavior
Pediatric Quality of Life Inventory (PedsQL)	Week 10	Child functioning and quality of life
Dyadic Parent Child Interaction Coding System (DPICS)	Week 10	Parenting Behaviors
Satisfaction Survey	Week 10	Satisfaction with Intervention
Child Behavior Checklist	Week 10	Child Behavior
Center for Epidemiologic Studies Depression Scale (CES-D)	Week 10	Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Adverse Childhood Experiences Scales (ACES)	Week 10	Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.

Secondary Outcome Measures

Name	Time	Method
Resting state fMRI sequence	Week 10	Neuroimaging-MRI/DTI
Multi-shell diffusion sequence	Week 10	Neuroimaging-MRI/DTI
3D T2- weighted sequence	Week 10	Neuroimaging-MRI/DTI
3D-T1 weighted sequences	Week 10	Neuroimaging-MRI/DTI

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States