Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT06256939
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.
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Interventional
Not applicable
Cincinnati, Ohio, 45229, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for infant participants:
Inclusion criteria
for caregiver participants:
Exclusion criteria
for infant and caregiver participants:
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.
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).
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).
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).
Children's Hospital Medical Center, Cincinnati
Other
Acronym: Therapy BRIDGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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