Parent Communication for Feeding an Infant With a Heart Defect

June 30, 2020 updated by: University of Wisconsin, Madison

Parent Communication for Feeding an Infant With a Heart Defect - Pilot Intervention Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • American Family Children's Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Behavioral: 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.
Other Names:
  • GP
No Intervention: Usual Care (UC)
The UC group will receive standard of care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
month 2
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.
month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent-Child Early Relational Assessment (ERA) Scores
Time Frame: up to one week
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.
up to one week
Parent-Child Early Relational Assessment (ERA) Scores
Time Frame: 2 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.
2 months
Parent-Child Early Relational Assessment (ERA) Scores
Time Frame: 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.
6 months
Infant Heart Rate Variability
Time Frame: up to 6 weeks
Infant heart rate variability is a measure of infant physiologic and bio-behavioral regulation.
up to 6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infant Length
Time Frame: up to 6 weeks
up to 6 weeks
Infant Weight
Time Frame: up to 6 weeks
up to 6 weeks
Infant Head Circumference
Time Frame: up to 6 weeks
up to 6 weeks
Bayley III assessment Scores
Time Frame: 6 months
Each scale (Motor, Cognitive, Language) is assessed and treated separately. The Motor score includes fine and gross motor sub-test scores. The Cognitive score assesses cognitive development. The Language subscales are for assessment of expressive and language development. Scales are scored to a metric with a mean of 100, standard deviation of 14, and range from 40 to 160. A higher score indicates better development. A score below 85 indicates clinical concern.
6 months
Satisfaction with Life Scale (SWLS)
Time Frame: baseline
Quality of life was assessed using the SWLS. The SWLS is a 5-item survey, each item is scored on a 7 point likert scale where 1 is 'strongly disagree' and 7 is 'strongly agree'. The total possible range of scores is 7-35. Higher total scores indicate more satisfaction in life.
baseline
Satisfaction with Life Scale (SWLS)
Time Frame: up to one week
Quality of life was assessed using the SWLS. The SWLS is a 5-item survey, each item is scored on a 7 point likert scale where 1 is 'strongly disagree' and 7 is 'strongly agree'. The total possible range of scores is 7-35. Higher total scores indicate more satisfaction in life.
up to one week
Satisfaction with Life Scale (SWLS)
Time Frame: 2 months
Quality of life was assessed using the SWLS. The SWLS is a 5-item survey, each item is scored on a 7 point likert scale where 1 is 'strongly disagree' and 7 is 'strongly agree'. The total possible range of scores is 7-35. Higher total scores indicate more satisfaction in life.
2 months
Satisfaction with Life Scale (SWLS)
Time Frame: 6 months
Quality of life was assessed using the SWLS. The SWLS is a 5-item survey, each item is scored on a 7 point likert scale where 1 is 'strongly disagree' and 7 is 'strongly agree'. The total possible range of scores is 7-35. Higher total scores indicate more satisfaction in life.
6 months
Cutrona Social Provisions Scale
Time Frame: baseline
Parental Relationship Quality was measured using the Cutrona Social Provisions Scale. This is a 24-item self report assessment, each item scored on a 4 point likert scale where 1 is 'strongly disagree' and 4 is 'strongly agree'. The range of total possible scores is 24-96.
baseline
Cutrona Social Provisions Scale
Time Frame: up to one week
Parental Relationship Quality was measured using the Cutrona Social Provisions Scale. This is a 24-item self report assessment, each item scored on a 4 point likert scale where 1 is 'strongly disagree' and 4 is 'strongly agree'. The range of total possible scores is 24-96.
up to one week
Cutrona Social Provisions Scale
Time Frame: 2 months
Parental Relationship Quality was measured using the Cutrona Social Provisions Scale. This is a 24-item self report assessment, each item scored on a 4 point likert scale where 1 is 'strongly disagree' and 4 is 'strongly agree'. The range of total possible scores is 24-96.
2 months
Cutrona Social Provisions Scale
Time Frame: 6 months
Parental Relationship Quality was measured using the Cutrona Social Provisions Scale. This is a 24-item self report assessment, each item scored on a 4 point likert scale where 1 is 'strongly disagree' and 4 is 'strongly agree'. The range of total possible scores is 24-96.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Heart Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen Pridham, PhD, RN, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-0718
  • A545000 (Other Identifier: UW Madison)
  • Protocol Version 6/27/2017 (Other Identifier: UW Madison)
  • NUR/FACULTY (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 3 months after publication of primary outcomes, and ending 5 years after that date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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