Therapy BRIDGE (Bringing Real-Time Instruction Via Developmental and Gestationally-appropriate Education/Coaching) Program: a Pilot Study (Therapy BRIDGE)

February 18, 2025 updated by: Grace Sagester, Children's Hospital Medical Center, Cincinnati

The goal of this pilot study is to develop a novel caregiver education and coaching intervention for infants with intraventricular hemorrhage (IVH) and their caregivers during the NICU to home transition. The main questions it aims to answer are:

  1. Development of a novel caregiver education and coaching intervention focused on infant development and caregiver needs to "bridge the gap" during the NICU to home transition
  2. Pilot test the feasibility, acceptability, and efficacy of this program for infants with intraventricular hemorrhage (IVH) and their caregivers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infants born preterm are often medically complex and at high-risk for neurodevelopmental challenges. During their Neonatal Intensive Care Unit (NICU) stay, infants and caregivers receive continuous support and have constant access to a variety of specialists. Research has shown that caregiver involvement in their infant's care in the NICU helps to improve outcomes. However, caring for these infants upon discharge can be overwhelming to caregivers. Currently, there is no formal intervention in place to support caregivers as they transition their infant home. The overall objectives of the Therapy BRIDGE program are to (1) create a novel caregiver education and coaching intervention focused on infant development and caregiver needs to "bridge the gap" during the NICU to home transition and (2) pilot test the feasibility, acceptability, and efficacy of this program for infants with intraventricular hemorrhage (IVH) and their caregivers.

A standardized education and coaching intervention will be developed to promote optimal neurodevelopmental outcomes through caregiver empowerment. This pilot study will enroll up to 15 infants with IVH and their caregivers during their NICU stay. These infant-caregiver dyads will receive up to 10 sessions utilizing the Therapy BRIDGE program over a four-month period that spans the hospital to home transition. Feasibility and acceptability will be measured with caregiver and therapist questionnaires using a 5-point Likert Scale. Intervention efficacy will be measured by administering the Canadian Occupational Performance Measure (COPM) before and after completion of the program and evaluating change scores.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for infant participants:

  • A diagnosis of IVH, regardless of age at time of enrollment
  • Admission to the Cincinnati Children's Hospital NICU

Inclusion Criteria for caregiver participants:

  • Must be at least 18 years of age
  • Can provide written consent
  • Able to participate in the sessions and data collection process

Exclusion Criteria for infant and caregiver participants:

  • Transfer out of the NICU prior to discharge or require tracheostomy with ventilator dependence as they will not be discharged directly from the CCHMC NICU
  • Infants and caregivers who live outside of the CCHMC service area and will not be eligible for follow up with CCHMC therapies will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The Therapy BRIDGE program is a prospective, longitudinal, non-randomized pilot study for infants diagnosed with IVH and their caregivers. The Therapy BRIDGE program will begin as the infant is nearing discharge from the NICU and continue as the infant transitions to home. It will use a hybrid model including both in-person and telehealth sessions.
Other: Therapy BRIDGE Program
A standardized education and coaching intervention will be developed to promote optimal neurodevelopmental outcomes through caregiver empowerment. This pilot study will enroll up to 15 infants with IVH and their caregivers during their NICU stay. These infant-caregiver dyads will receive up to 10 sessions utilizing the Therapy BRIDGE program over a four-month period that spans the hospital to home transition.
No Intervention: Control Group
In the instance that a patient is deemed eligible to participate in the Therapy BRIDGE program and the caregiver chooses not to participate, the caregiver will be offered the opportunity to be enrolled in the control arm of our study as part of a monitoring group. This group of patients will continue to receive usual care while admitted to the NICU and any outpatient recommendations will be deferred to the primary NICU therapists caring for the infant based on the patient's individualized needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure (COPM)
Time Frame: At enrollment and through study completion, an average of 2 months
A client-centered outcome measure that helps identify and prioritize barriers that limit participation in meaningful activities (e.g., play, feeding, sleep, etc.). The COPM is a valid, responsive, and reliable scale that allows researchers to determine clinically significant changes in participants' performance and satisfaction. Participants will rate items on a scale of 1-10 with the average performance/satisfaction scores calculated (higher correlates with higher satisfaction/performance).
At enrollment and through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Questionnaire of Perceived Feasibility & Acceptability of Therapy BRIDGE Program
Time Frame: At enrollment and through study completion, an average of 2 months
Caregiver questionnaire to measure feasibility and acceptability. Participants will rate items on a scale of 1-5 with the average scores calculated (higher correlates with higher acceptance/performance).
At enrollment and through study completion, an average of 2 months
Therapist Questionnaire of Acceptability of Therapy BRIDGE Program
Time Frame: To be completed at study completion, an average of 2 months after enrollment
Questionnaire to measure therapist's acceptability of novel education program. Participants will rate items on a scale of 1-5 with the average scores calculated (higher correlates with higher acceptance/performance).
To be completed at study completion, an average of 2 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Grace Sagester, OTD, OTR/L, BCP, Children's Hospital Medical Center, Cincinnati
  • Principal Investigator: Ashley Pinger, PT, DPT, PCS, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2023

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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