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I-InTERACT Preterm

Primary Purpose

Pre-Term

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Building Better Brains and Behavior program (B4 Preterm)
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-Term

Eligibility Criteria

36 Months - 96 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Building Better Brains and Behavior program (B4 Preterm)

Arm Description

Online learning modules completed sequentially and in conjunction with live coaching sessions led by a trained therapist.

Outcomes

Primary Outcome Measures

Eyberg Child Behavior Inventory (ECBI)
Child Behavior
Eyberg Child Behavior Inventory (ECBI)
Child Behavior
Child Behavior Checklist
Child Behavior
Child Behavior Checklist
Child Behavior
Behavior Rating Inventory of Executive Functions-2
Executive Function Behaviors
Behavior Rating Inventory of Executive Functions-2
Executive Function Behaviors
Center for Epidemiologic Studies Depression Scale (CES-D)
Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Center for Epidemiologic Studies Depression Scale (CES-D)
Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
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.
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.
Pediatric Quality of Life Inventory (PedsQL)
Child functioning and quality of life
Pediatric Quality of Life Inventory (PedsQL)
Child functioning and quality of life
Dyadic Parent Child Interaction Coding System (DPICS)
Parenting Behaviors
Dyadic Parent Child Interaction Coding System (DPICS)
Parenting Behaviors
Satisfaction Survey
Satisfaction with Intervention

Secondary Outcome Measures

Multi-shell diffusion sequence
Neuroimaging-MRI/DTI
Multi-shell diffusion sequence
Neuroimaging-MRI/DTI
3D-T1 weighted sequences
Neuroimaging-MRI/DTI
3D-T1 weighted sequences
Neuroimaging-MRI/DTI
3D T2- weighted sequence
Neuroimaging-MRI/DTI
3D T2- weighted sequence
Neuroimaging-MRI/DTI
Resting state fMRI sequence
Neuroimaging-MRI/DTI
Resting state fMRI sequence
Neuroimaging-MRI/DTI

Full Information

First Posted
August 31, 2021
Last Updated
February 6, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT05282628
Brief Title
I-InTERACT Preterm
Official Title
I-InTERACT Preterm
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Term

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Building Better Brains and Behavior program (B4 Preterm)
Arm Type
Experimental
Arm Description
Online learning modules completed sequentially and in conjunction with live coaching sessions led by a trained therapist.
Intervention Type
Behavioral
Intervention Name(s)
Building Better Brains and Behavior program (B4 Preterm)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory (ECBI)
Description
Child Behavior
Time Frame
Week 1
Title
Eyberg Child Behavior Inventory (ECBI)
Description
Child Behavior
Time Frame
Week 10
Title
Child Behavior Checklist
Description
Child Behavior
Time Frame
Week 1
Title
Child Behavior Checklist
Description
Child Behavior
Time Frame
Week 10
Title
Behavior Rating Inventory of Executive Functions-2
Description
Executive Function Behaviors
Time Frame
Week 1
Title
Behavior Rating Inventory of Executive Functions-2
Description
Executive Function Behaviors
Time Frame
Week 10
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time Frame
Week 1
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time Frame
Week 10
Title
Adverse Childhood Experiences Scales (ACES)
Description
Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.
Time Frame
Week 1
Title
Adverse Childhood Experiences Scales (ACES)
Description
Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.
Time Frame
Week 10
Title
Pediatric Quality of Life Inventory (PedsQL)
Description
Child functioning and quality of life
Time Frame
Week 1
Title
Pediatric Quality of Life Inventory (PedsQL)
Description
Child functioning and quality of life
Time Frame
Week 10
Title
Dyadic Parent Child Interaction Coding System (DPICS)
Description
Parenting Behaviors
Time Frame
Week 1
Title
Dyadic Parent Child Interaction Coding System (DPICS)
Description
Parenting Behaviors
Time Frame
Week 10
Title
Satisfaction Survey
Description
Satisfaction with Intervention
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Multi-shell diffusion sequence
Description
Neuroimaging-MRI/DTI
Time Frame
Week 1
Title
Multi-shell diffusion sequence
Description
Neuroimaging-MRI/DTI
Time Frame
Week 10
Title
3D-T1 weighted sequences
Description
Neuroimaging-MRI/DTI
Time Frame
Week 1
Title
3D-T1 weighted sequences
Description
Neuroimaging-MRI/DTI
Time Frame
Week 10
Title
3D T2- weighted sequence
Description
Neuroimaging-MRI/DTI
Time Frame
Week 1
Title
3D T2- weighted sequence
Description
Neuroimaging-MRI/DTI
Time Frame
Week 10
Title
Resting state fMRI sequence
Description
Neuroimaging-MRI/DTI
Time Frame
Week 1
Title
Resting state fMRI sequence
Description
Neuroimaging-MRI/DTI
Time Frame
Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
96 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari L Wade, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

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I-InTERACT Preterm

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