Parent Communication for Feeding an Infant With a Heart Defect

Communication Clinical Trial

Official title: Parent Communication for Feeding an Infant With a Heart Defect - Pilot Intervention Study

Status Completed

Clinical Trial Summary

The purpose of this study is to pilot test an innovative, guided participation (GP) intervention to help parents develop competencies in communication for parenting an infant with a complex congenital heart defect (CCHD) through the first six months of age.

Clinical Trial Description

Study aims are to:

• Investigate the intervention feasibility (capability of being done, carried out, and objectives accomplished), accessibility, acceptability, usefulness, safety, and cost.

• Explore the effect of the GP intervention on outcomes within and between groups and over time.

Sample and Groups:

Parents will be recruited to the study either following a prenatal or postnatal diagnosis of a complex congenital heart defect. 36 families will be recruited and then computer randomized to either the GP or usual care (UC) groups in a 2:1 ratio, with a goal of 30 families completing the study (20 GP families, 10, UC families). Six of the families will be enrolled at American Family Children's Hospital (Madison, WI) (AFCH), with the rest enrolled at CHW. Each participating parent couple will receive an electronic tablet that will be the couple's to keep. A library of published materials from the UW-Health Sciences Library about infant care has been installed on the Tablets for both groups.

GP couples' participation together in development of communication competencies in the context of infant care will be supported by a handbook that is installed on the tablet as well as being given to parents in hard copy, and by telephone guidance, structured for collaboration with the nurse/research assistant beginning at approximately 2 weeks of age. Two face-to-face sessions are expected prior to hospital discharge, followed by 5 or 6 monthly phone sessions. If the baby is inpatient at the time an intervention session is to take place, the session may be done face-to-face, if more convenient than a phone session for the parents.

For both GP and UC groups, data will be collected prior to the infant's discharge from the hospital and at 2 and 6 months after the infant's birth. Two severity of infant illness scores will be computed by a pediatric cardiologist, the first for the neonatal period and the second when the infant is 6 months old. The data collections plus a monthly phone call to learn about infant and family changes make the UC group an attention control group.

A survey regarding use of the materials supplied as part of the study and the couple's communication will be collected at 4 time points from parents in both groups. Baseline and soon after the baby begins oral feeding (up to to one week, both before hospital discharge) and, 2 months and 6 months (both at home, 6 months is end of study).

Each data collection visit will include:

• self-report surveys

• assessment of heart-rate variability (HRV)

• an initial 20-minute interview about what the parents are experiencing and working on as parents, how they are managing stressors, and how caregiving is going

• an infant feeding of usual length

• an approximately 30-minute interview concerning the parents' internal working model of feeding, parenting communication and co-parenting pattern

• a couple problem-solving session with two 7-minute problems, each followed by independent evaluation of the problem session by each parent

• following each visit, data will be obtained from the infant's electronic health record

• anthropometric data (weight, length, head circumference)

• illness and treatments

• medical procedures

• neurodevelopmental progress

The feeding and the problem solving will be video recorded for in-laboratory coding. ;

Related Conditions & MeSH terms

• Communication
• Congenital Abnormalities
• Heart Defects, Congenital
• Infant Conditions

• NCT number: NCT04452201
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Completed
• Phase: N/A
• Start date: February 25, 2015
• Completion date: June 24, 2019