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

NCT ID: NCT06256939

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2024-09-30

Brief Summary

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.

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.

Conditions

Intraventricular Hemorrhage

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapy BRIDGE Program

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Grace Sagester

Co-Principal Investigator, Occupational Therapist, Division of Occupational & Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace Sagester, OTD, OTR/L, BCP

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Ashley Pinger, PT, DPT, PCS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2023-0236

Identifier Type: -

Identifier Source: org_study_id