Clinical trial NCT04452201: Parent Communication for Feeding an Infant With a Heart Defect
Official title: Parent Communication for Feeding an Infant With a Heart Defect - Pilot Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Heart Defects, Congenital
Infant Conditions
Keywords: Communication
Parents
Infants
Congenital Heart Disease
Feeding
Caregiving
Guided Participation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2020-06-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics
timeFrame: month 2
measure: Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics
timeFrame: month 6
Secondary outcomes:
measure: Parent-Child Early Relational Assessment (ERA) Scores
timeFrame: up to one week
measure: Parent-Child Early Relational Assessment (ERA) Scores
timeFrame: 2 months
measure: Parent-Child Early Relational Assessment (ERA) Scores
timeFrame: 6 months
measure: Infant Heart Rate Variability
timeFrame: up to 6 weeks
Other outcomes:
measure: Infant Length
timeFrame: up to 6 weeks
measure: Infant Weight
timeFrame: up to 6 weeks
measure: Infant Head Circumference
timeFrame: up to 6 weeks
measure: Bayley III assessment Scores
timeFrame: 6 months
measure: Satisfaction with Life Scale (SWLS)
timeFrame: baseline
measure: Satisfaction with Life Scale (SWLS)
timeFrame: up to one week
measure: Satisfaction with Life Scale (SWLS)
timeFrame: 2 months
measure: Satisfaction with Life Scale (SWLS)
timeFrame: 6 months
measure: Cutrona Social Provisions Scale
timeFrame: baseline
measure: Cutrona Social Provisions Scale
timeFrame: up to one week
measure: Cutrona Social Provisions Scale
timeFrame: 2 months
measure: Cutrona Social Provisions Scale
timeFrame: 6 months
Locations:
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Karen Pridham, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pridham K, Brown R, Clark R, Limbo RK, Schroeder M, Henriques J, Bohne E. Effect of guided participation on feeding competencies of mothers and their premature infants. Res Nurs Health. 2005 Jun;28(3):252-67. doi: 10.1002/nur.20073.
citation: Pridham KF, Limbo R, Schroeder M. (Eds.). (2018). Guided participation in pediatric nursing practice: Relationship-based teaching and learning with parents, children, and adolescents. New York: Springer.