Parent Communication for Feeding an Infant With a Heart Defect

Not Applicable

Completed

• Conditions: Heart Defects, Congenital; Communication; Infant Conditions

• Registration Number: NCT04452201
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-02-25
• Primary Completion: 2019-05-02
• Study Completion: 2019-06-24
• Status Verified: 2020-06
• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Parent couples will be married or partnered (living together),
• English speaking and reading
• Infants will have a CCHD diagnosed by the first week of life, requiring palliative or reparative surgery within the baby's first year

Exclusion Criteria

• Families will be excluded if either parent is not willing to participate, or is unable to participate due to a communication barrier
• Families will be excluded if either parent is known to have a mental illness that interferes with day-to-day functions or a substance use problem

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics	month 6	The IFIRS is an Observational macrocoding system where recorded interviews are coded and each code is given a single score upon review. Scores are 1-9 where 1 indicates that the behavior did not occur and 9 indicates the behavior almost always occurs. Families were scored on the following codes at 2 and 6 months: goal setting, problem solving, negotiating issues, and emotion regulating during problem solving.

Secondary Outcome Measures

Name	Time	Method
Infant Heart Rate Variability	up to 6 weeks	Infant heart rate variability is a measure of infant physiologic and bio-behavioral regulation.
Parent-Child Early Relational Assessment (ERA) Scores	6 months	The ERA is an observational measure of parental mental attunement and sensitivity and responsiveness to the infant and of the infant's responsive and regulated behavior during feeding. The mean score for each of the six subscale scores are reported: Parental Positive Affective Involvement, sensitivity, \& Responsiveness; Parental Negative Affect and behavior (a higher score indicates less of the parental negative affect and behavior); Infant Positive Affect \& Communicative and Social Skills; Infant Dysregulation and Irritability; Dyadic Mutuality and Reciprocity; Dyadic Tension. Each item is rated on a 1-5 scale. Five indicates adaptive behavior. Scores may be treated as follows: 4-5 indicates behavior that is positive and of no clinical concern; 3 indicates there is some clinical concern about the behavior; 1-2 indicates behavior of clinical concern.

Trial Locations

Locations (2)

American Family Children's Hospital; 🇺🇸 Madison, Wisconsin, United States

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States