Parent Communication for Feeding an Infant With a Heart Defect - Pilot Intervention Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Guided Participation (GP)
A GP intervention is participatory formal and informal education to support learning of a practice beyond what could occur as efficiently and effectively without guidance. GP uses strategies for teaching-learning that make best use of the family's situation and opportunities, tailored to the parents' needs. The overall goal of the GP intervention is to support parent couples in effectively communicating for parenting work, including care-giving and maintaining the couple's relationship
Intervention: Guided Participation (Behavioral)
Usual Care (UC)
The UC group will receive standard of care
Outcomes
Primary Outcomes
Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics
Time Frame: 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.
Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics
Time Frame: month 2
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 Outcomes
- Infant Heart Rate Variability(up to 6 weeks)
- Parent-Child Early Relational Assessment (ERA) Scores(6 months)
- Parent-Child Early Relational Assessment (ERA) Scores(up to one week)
- Parent-Child Early Relational Assessment (ERA) Scores(2 months)