Clinical trial NCT06256939: Therapy BRIDGE (Bringing Real-Time Instruction Via Developmental and Gestationally-appropriate Education/Coaching) Program: A Pilot Study
Official title: Therapy BRIDGE (Bringing Real-Time Instruction Via Developmental and Gestationally-appropriate Education/Coaching) Program: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraventricular Hemorrhage
Keywords: IVH
NICU
caregiver education
occupational therapy
physical therapy
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: At enrollment and through study completion, an average of 2 months
Secondary outcomes:
measure: Caregiver Questionnaire of Perceived Feasibility & Acceptability of Therapy BRIDGE Program
timeFrame: At enrollment and through study completion, an average of 2 months
measure: Therapist Questionnaire of Acceptability of Therapy BRIDGE Program
timeFrame: To be completed at study completion, an average of 2 months after enrollment
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Grace Sagester, OTD, OTR/L, BCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Ashley Pinger, PT, DPT, PCS
role: PRINCIPAL_INVESTIGATOR
References: