I-InTERACT Preterm

N/AActive Not RecruitingNCT05282628

Children's Hospital Medical Center, Cincinnati19 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pre-Term

Interventions

Building Better Brains and Behavior program (B4 Preterm)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 36 MonthsMax age: 96 Months

Medical Language ↔ Plain English

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.

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Eyberg Child Behavior Inventory (ECBI)

Child Behavior

Time frame: Week 1

Eyberg Child Behavior Inventory (ECBI)

Child Behavior

Time frame: Week 10

Child Behavior Checklist

Child Behavior

Time frame: Week 1

Child Behavior Checklist

Child Behavior

Time frame: Week 10

Behavior Rating Inventory of Executive Functions-2

Executive Function Behaviors

Time frame: Week 1

Behavior Rating Inventory of Executive Functions-2

Executive Function Behaviors

Time frame: Week 10

Center for Epidemiologic Studies Depression Scale (CES-D)

Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Time frame: Week 1

Center for Epidemiologic Studies Depression Scale (CES-D)

Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Time frame: Week 10

Adverse Childhood Experiences Scales (ACES)

Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.

Time frame: Week 1

Data from ClinicalTrials.gov

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Secondary Outcomes

Multi-shell diffusion sequence

Neuroimaging-MRI/DTI

Time frame: Week 1

Multi-shell diffusion sequence

Neuroimaging-MRI/DTI

Time frame: Week 10

3D-T1 weighted sequences

Neuroimaging-MRI/DTI

Time frame: Week 1

3D-T1 weighted sequences

Neuroimaging-MRI/DTI

Time frame: Week 10

3D T2- weighted sequence

Neuroimaging-MRI/DTI

Time frame: Week 1

3D T2- weighted sequence

Neuroimaging-MRI/DTI

Time frame: Week 10

Resting state fMRI sequence

Neuroimaging-MRI/DTI

Time frame: Week 1

Resting state fMRI sequence

Neuroimaging-MRI/DTI

Time frame: Week 10