Parent Communication for Feeding an Infant With a Heart Defect
4 other identifiers
interventional
35
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2019
CompletedFirst Submitted
Initial submission to the registry
June 25, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedJuly 1, 2020
June 1, 2020
4.2 years
June 25, 2020
June 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics
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.
month 2
Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics
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.
month 6
Secondary Outcomes (4)
Parent-Child Early Relational Assessment (ERA) Scores
up to one week
Parent-Child Early Relational Assessment (ERA) Scores
2 months
Parent-Child Early Relational Assessment (ERA) Scores
6 months
Infant Heart Rate Variability
up to 6 weeks
Other Outcomes (12)
Infant Length
up to 6 weeks
Infant Weight
up to 6 weeks
Infant Head Circumference
up to 6 weeks
- +9 more other outcomes
Study Arms (2)
Guided Participation (GP)
EXPERIMENTALA 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
Usual Care (UC)
NO INTERVENTIONThe UC group will receive standard of care
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- American Heart Associationcollaborator
Study Sites (2)
American Family Children's Hospital
Madison, Wisconsin, 53792, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
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.
PMID: 15884024BACKGROUNDPridham 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Pridham, PhD, RN
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2020
First Posted
June 30, 2020
Study Start
February 25, 2015
Primary Completion
May 2, 2019
Study Completion
June 24, 2019
Last Updated
July 1, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Beginning 3 months after publication of primary outcomes, and ending 5 years after that date.
- Access Criteria
- Proposals should be directed to kpridham@wisc.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.
De-identified data collected during the trial, including parents' interview data; coded infant feeding skills; growth and development data; summary measures for heart-rate variability, and parent-child relationship assessment item scores. Researchers, including doctoral students in nursing, whose proposed use of the data for subsequent clinical research has been approved by an independent review committee identified for this purpose.