Parent Communication for Feeding an Infant With a Heart Defect

NCT ID: NCT04452201

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-25
• Study Completion Date: 2019-06-24

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.

Conditions

Communication; Heart Defects, Congenital; Infant Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Guided Participation

Intervention Type: BEHAVIORAL

GP couples' participation together in development of communication competencies in the context of infant care will be supported by a handbook and 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.

Usual Care (UC)

The UC group will receive standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Guided Participation

GP couples' participation together in development of communication competencies in the context of infant care will be supported by a handbook and 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

GP

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Pridham, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

American Family Children's Hospital

Madison, Wisconsin, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15884024 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

Protocol Version 6/27/2017

Identifier Type: OTHER

Identifier Source: secondary_id

A545000

Identifier Type: OTHER

Identifier Source: secondary_id

NUR/FACULTY

Identifier Type: OTHER

Identifier Source: secondary_id

2014-0718

Identifier Type: -

Identifier Source: org_study_id