<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04452201</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0718</org_study_id>
    <secondary_id>Protocol Version 6/27/2017</secondary_id>
    <secondary_id>A545000</secondary_id>
    <secondary_id>NUR/FACULTY</secondary_id>
    <nct_id>NCT04452201</nct_id>
  </id_info>
  <brief_title>Parent Communication for Feeding an Infant With a Heart Defect</brief_title>
  <official_title>Parent Communication for Feeding an Infant With a Heart Defect - Pilot Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to pilot test an innovative, guided participation (GP)&#xD;
      intervention to help parents develop competencies in communication for parenting an infant&#xD;
      with a complex congenital heart defect (CCHD) through the first six months of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study aims are to:&#xD;
&#xD;
        -  Investigate the intervention feasibility (capability of being done, carried out, and&#xD;
           objectives accomplished), accessibility, acceptability, usefulness, safety, and cost.&#xD;
&#xD;
        -  Explore the effect of the GP intervention on outcomes within and between groups and over&#xD;
           time.&#xD;
&#xD;
      Sample and Groups:&#xD;
&#xD;
      Parents will be recruited to the study either following a prenatal or postnatal diagnosis of&#xD;
      a complex congenital heart defect. 36 families will be recruited and then computer randomized&#xD;
      to either the GP or usual care (UC) groups in a 2:1 ratio, with a goal of 30 families&#xD;
      completing the study (20 GP families, 10, UC families). Six of the families will be enrolled&#xD;
      at American Family Children's Hospital (Madison, WI) (AFCH), with the rest enrolled at CHW.&#xD;
      Each participating parent couple will receive an electronic tablet that will be the couple's&#xD;
      to keep. A library of published materials from the UW-Health Sciences Library about infant&#xD;
      care has been installed on the Tablets for both groups.&#xD;
&#xD;
      GP couples' participation together in development of communication competencies in the&#xD;
      context of infant care will be supported by a handbook that is installed on the tablet as&#xD;
      well as being given to parents in hard copy, and by telephone guidance, structured for&#xD;
      collaboration with the nurse/research assistant beginning at approximately 2 weeks of age.&#xD;
      Two face-to-face sessions are expected prior to hospital discharge, followed by 5 or 6&#xD;
      monthly phone sessions. If the baby is inpatient at the time an intervention session is to&#xD;
      take place, the session may be done face-to-face, if more convenient than a phone session for&#xD;
      the parents.&#xD;
&#xD;
      For both GP and UC groups, data will be collected prior to the infant's discharge from the&#xD;
      hospital and at 2 and 6 months after the infant's birth. Two severity of infant illness&#xD;
      scores will be computed by a pediatric cardiologist, the first for the neonatal period and&#xD;
      the second when the infant is 6 months old. The data collections plus a monthly phone call to&#xD;
      learn about infant and family changes make the UC group an attention control group.&#xD;
&#xD;
      A survey regarding use of the materials supplied as part of the study and the couple's&#xD;
      communication will be collected at 4 time points from parents in both groups. Baseline and&#xD;
      soon after the baby begins oral feeding (up to to one week, both before hospital discharge)&#xD;
      and, 2 months and 6 months (both at home, 6 months is end of study).&#xD;
&#xD;
      Each data collection visit will include:&#xD;
&#xD;
        -  self-report surveys&#xD;
&#xD;
        -  assessment of heart-rate variability (HRV)&#xD;
&#xD;
        -  an initial 20-minute interview about what the parents are experiencing and working on as&#xD;
           parents, how they are managing stressors, and how caregiving is going&#xD;
&#xD;
        -  an infant feeding of usual length&#xD;
&#xD;
        -  an approximately 30-minute interview concerning the parents' internal working model of&#xD;
           feeding, parenting communication and co-parenting pattern&#xD;
&#xD;
        -  a couple problem-solving session with two 7-minute problems, each followed by&#xD;
           independent evaluation of the problem session by each parent&#xD;
&#xD;
        -  following each visit, data will be obtained from the infant's electronic health record&#xD;
&#xD;
             -  anthropometric data (weight, length, head circumference)&#xD;
&#xD;
             -  illness and treatments&#xD;
&#xD;
             -  medical procedures&#xD;
&#xD;
             -  neurodevelopmental progress&#xD;
&#xD;
      The feeding and the problem solving will be video recorded for in-laboratory coding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2015</start_date>
  <completion_date type="Actual">June 24, 2019</completion_date>
  <primary_completion_date type="Actual">May 2, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics</measure>
    <time_frame>month 2</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics</measure>
    <time_frame>month 6</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parent-Child Early Relational Assessment (ERA) Scores</measure>
    <time_frame>up to one week</time_frame>
    <description>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, &amp; Responsiveness; Parental Negative Affect and behavior (a higher score indicates less of the parental negative affect and behavior); Infant Positive Affect &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-Child Early Relational Assessment (ERA) Scores</measure>
    <time_frame>2 months</time_frame>
    <description>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, &amp; Responsiveness; Parental Negative Affect and behavior (a higher score indicates less of the parental negative affect and behavior); Infant Positive Affect &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-Child Early Relational Assessment (ERA) Scores</measure>
    <time_frame>6 months</time_frame>
    <description>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, &amp; Responsiveness; Parental Negative Affect and behavior (a higher score indicates less of the parental negative affect and behavior); Infant Positive Affect &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Heart Rate Variability</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>Infant heart rate variability is a measure of infant physiologic and bio-behavioral regulation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Infant Length</measure>
    <time_frame>up to 6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Infant Weight</measure>
    <time_frame>up to 6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Infant Head Circumference</measure>
    <time_frame>up to 6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Bayley III assessment Scores</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>baseline</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>up to one week</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>2 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cutrona Social Provisions Scale</measure>
    <time_frame>baseline</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cutrona Social Provisions Scale</measure>
    <time_frame>up to one week</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cutrona Social Provisions Scale</measure>
    <time_frame>2 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cutrona Social Provisions Scale</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Communication</condition>
  <condition>Heart Defects, Congenital</condition>
  <condition>Infant Conditions</condition>
  <arm_group>
    <arm_group_label>Guided Participation (GP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care (UC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The UC group will receive standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Guided Participation</intervention_name>
    <description>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.</description>
    <arm_group_label>Guided Participation (GP)</arm_group_label>
    <other_name>GP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent couples will be married or partnered (living together),&#xD;
&#xD;
          -  English speaking and reading&#xD;
&#xD;
          -  Infants will have a CCHD diagnosed by the first week of life, requiring palliative or&#xD;
             reparative surgery within the baby's first year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Families will be excluded if either parent is not willing to participate, or is unable&#xD;
             to participate due to a communication barrier&#xD;
&#xD;
          -  Families will be excluded if either parent is known to have a mental illness that&#xD;
             interferes with day-to-day functions or a substance use problem&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Pridham, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American Family Children's Hospital</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>15884024</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Communication</keyword>
  <keyword>Parents</keyword>
  <keyword>Infants</keyword>
  <keyword>Congenital Heart Disease</keyword>
  <keyword>Feeding</keyword>
  <keyword>Caregiving</keyword>
  <keyword>Guided Participation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Beginning 3 months after publication of primary outcomes, and ending 5 years after that date.</ipd_time_frame>
    <ipd_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_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04452201
org study id: 2014-0718
secondary id: Protocol Version 6/27/2017
secondary id: A545000
secondary id: NUR/FACULTY
nct id: NCT04452201
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics
time frame: month 2
description: 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.
measure: Iowa Family Interaction Rating Scales (IFIRS) scores to measure family dynamics
time frame: month 6
description: 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.
measure: Parent-Child Early Relational Assessment (ERA) Scores
time frame: up to one week
description: 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.
measure: Parent-Child Early Relational Assessment (ERA) Scores
time frame: 2 months
description: 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.
measure: Parent-Child Early Relational Assessment (ERA) Scores
time frame: 6 months
description: 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.
measure: Infant Heart Rate Variability
time frame: up to 6 weeks
description: Infant heart rate variability is a measure of infant physiologic and bio-behavioral regulation.
measure: Infant Length
time frame: up to 6 weeks
measure: Infant Weight
time frame: up to 6 weeks
measure: Infant Head Circumference
time frame: up to 6 weeks
measure: Bayley III assessment Scores
time frame: 6 months
description: 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.
measure: Satisfaction with Life Scale (SWLS)
time frame: baseline
description: 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.
measure: Satisfaction with Life Scale (SWLS)
time frame: up to one week
description: 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.
measure: Satisfaction with Life Scale (SWLS)
time frame: 2 months
description: 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.
measure: Satisfaction with Life Scale (SWLS)
time frame: 6 months
description: 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.
measure: Cutrona Social Provisions Scale
time frame: baseline
description: 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.
measure: Cutrona Social Provisions Scale
time frame: up to one week
description: 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.
measure: Cutrona Social Provisions Scale
time frame: 2 months
description: 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.
measure: Cutrona Social Provisions Scale
time frame: 6 months
description: 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.
arm group label: Guided Participation (GP)
arm group type: Experimental
description: 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
arm group label: Usual Care (UC)
arm group type: No Intervention
description: The UC group will receive standard of care
intervention type: Behavioral
intervention name: Guided Participation
description: 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.
arm group label: Guided Participation (GP)
other name: GP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karen Pridham, PhD, RN
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
facility: 
country: United States
citation: 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: 15884024
citation: 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.
responsible party type: Sponsor
mesh term: Heart Defects, Congenital
mesh term: Congenital Abnormalities
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Beginning 3 months after publication of primary outcomes, and ending 5 years after that date.
ipd 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.