I-InTERACT Preterm

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pre-Term
• Intervention / Treatment: Behavioral: Building Better Brains and Behavior program (B4 Preterm)

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eyberg Child Behavior Inventory (ECBI)	Child Behavior	Week 1
Eyberg Child Behavior Inventory (ECBI)	Child Behavior	Week 10
Child Behavior Checklist	Child Behavior	Week 1
Child Behavior Checklist	Child Behavior	Week 10
Behavior Rating Inventory of Executive Functions-2	Executive Function Behaviors	Week 1
Behavior Rating Inventory of Executive Functions-2	Executive Function Behaviors	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.	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.	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.	Week 1
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.	Week 10
Pediatric Quality of Life Inventory (PedsQL)	Child functioning and quality of life	Week 1
Pediatric Quality of Life Inventory (PedsQL)	Child functioning and quality of life	Week 10
Dyadic Parent Child Interaction Coding System (DPICS)	Parenting Behaviors	Week 1
Dyadic Parent Child Interaction Coding System (DPICS)	Parenting Behaviors	Week 10
Satisfaction Survey	Satisfaction with Intervention	Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multi-shell diffusion sequence	Neuroimaging-MRI/DTI	Week 1
Multi-shell diffusion sequence	Neuroimaging-MRI/DTI	Week 10
3D-T1 weighted sequences	Neuroimaging-MRI/DTI	Week 1
3D-T1 weighted sequences	Neuroimaging-MRI/DTI	Week 10
3D T2- weighted sequence	Neuroimaging-MRI/DTI	Week 1
3D T2- weighted sequence	Neuroimaging-MRI/DTI	Week 10
Resting state fMRI sequence	Neuroimaging-MRI/DTI	Week 1
Resting state fMRI sequence	Neuroimaging-MRI/DTI	Week 10

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Shari L Wade, PhD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 315361

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No