CommunicationNCT04452201
Parent Communication for Feeding an Infant With a Heart Defect
A study testing Guided Participation in people with Communication and Heart Defects, Congenital, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Heart Defects, Congenital, Infant Conditions
- What is being tested?
- Guided Participation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Feb 2015to 24 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
American Family Children's Hospital
Madison, Wisconsin, 53792
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: 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.
Read the 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
- Being tested
- Guided Participation
- Keywords
- Communication, Parents, Infants, Congenital Heart Disease, Feeding, Caregiving, Guided Participation
- Medical subject headings
- Communication, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ParticipationBehavioural
Also called GP
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided Participation (GP) | Experimental | 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 Receives: Behavioral: Guided Participation |
| Usual Care (UC) | No intervention | The UC group will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: month 6
Secondary outcomes (4)
Parent-Child Early Relational Assessment (ERA) Scores
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.
Measured: up to one week
Parent-Child Early Relational Assessment (ERA) Scores
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.
Measured: 2 months
Parent-Child Early Relational Assessment (ERA) Scores
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.
Measured: 6 months
Infant Heart Rate Variability
Infant heart rate variability is a measure of infant physiologic and bio-behavioral regulation.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start25 Feb 2015
- Primary completion2 May 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Karen Pridham, PhD, RN, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452201
- Sponsor's protocol ID
- 2014-0718
- Other IDs
- Protocol Version 6/27/2017, A545000, NUR/FACULTY
- Status last verified
- Jun 2020
- First submitted
- 25 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 15884024Pridham 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Communication for Feeding an Infant With a Heart Defect - Pilot Intervention Study
- ClinicalTrials.gov ID
- NCT04452201
- Acronym / sponsor ID
- 2014-0718
- Conditions
- Communication, Heart Defects, Congenital, Infant Conditions
- Keywords
- Communication, Parents, Infants, Congenital Heart Disease, Feeding, Caregiving, Guided Participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 25 Feb 2015 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Participation (GP) | Experimental | Behavioral: Guided ParticipationA 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 intervention | –The UC group will receive standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ParticipationAlso: GPGP 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. | Behavioural | Guided Participation (GP) |
Primary outcome
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.
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.
4 secondary outcomes
Parent-Child Early Relational Assessment (ERA) Scores
Time frame: up to one week
Parent-Child Early Relational Assessment (ERA) Scores
Time frame: 2 months
Parent-Child Early Relational Assessment (ERA) Scores
Time frame: 6 months
Infant Heart Rate Variability
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Background: PubMed 15884024Pridham 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.
- BackgroundPridham 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Pridham, PhD, RN principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Participation in people with Communication and Heart Defects, Congenital, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics (time frame: month 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04452201, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.