xml: <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/NCT06022991</url>
    </required_header>
    <id_info>
      <org_study_id>152449</org_study_id>
      <nct_id>NCT06022991</nct_id>
    </id_info>
    <brief_title>Fathers and Partners in Family Integrated Care Study</brief_title>
    <acronym>TARGET</acronym>
    <official_title>TARGET Study: faThers And paRtners in Family inteGrated carE sTudy- A Prospective Multicentre Multiphase Study Investigating Father/Partner Involvement in Family Integrated Care in Neonatal Units</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Homerton University Hospital NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Homerton University Hospital NHS Foundation Trust</source>
    <oversight_info>
      <has_dmc>No</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>
        AIMS: The primary aim is to investigate the impact of enhancing father/partner engagement in&#xD;
        FICare of preterm infants on their mental health (MH) up to 6 weeks post discharge. Secondary&#xD;
        aims are to investigate the impact on maternal MH.&#xD;
  &#xD;
        METHOD and ANALYSIS: This is a two-phase study: Phase-1 to gather baseline information and&#xD;
        Phase-2 to assess the impact of improved father/partner engagement in FICare involving two&#xD;
        NUs (a tertiary and level 2). 20 families of infants born at &lt;33 weeks will be studied in&#xD;
        each phase (40 fathers, 40 mothers, 40 babies).&#xD;
  &#xD;
        Father/partner MH will be assessed using validated questionnaires: Generalised Anxiety&#xD;
        Disorder Assessment (GAD-7), Patient Health Questionnaire (PHQ-9), Parental Stressor Scale:&#xD;
        NICU (PSS:NICU), and by semi-structured qualitative interviews. Similarly, mothers will be&#xD;
        assessed by the same questionnaires and focus groups.&#xD;
  &#xD;
        The Neonatal DadPad materials will be updated using information from phase 1 study,&#xD;
        systematic review of Fathers experiences of FICare and advice from parent advisory group.&#xD;
        Father's engagement in FICare will be enhanced using Neonatal DadPad information booklet and&#xD;
        app, father-specific peer support and bitesize teaching on caring for NU babies (Phase 2).&#xD;
  &#xD;
        Thematic analysis of the qualitative data will be performed. Phase 1 and Phase 2 study&#xD;
        findings will be compared by performing appropriate statistical analysis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        BACKGROUND: Family-integrated care (FIC) is a culture whereby parents are viewed as&#xD;
        collaborators in their baby's care in neonatal units. This can be challenging for&#xD;
        fathers/non-birthing partners as they face competing demands on their time to try and allow&#xD;
        the mother to focus on her baby.&#xD;
  &#xD;
        KEY AIMS AND OBJECTIVES:&#xD;
  &#xD;
        Aims To undertake an in-depth longitudinal study of the engagement of fathers/partners in&#xD;
        FiCare and their experience and mental health (MH) from neonatal unit admission to 6 weeks&#xD;
        post discharge of their premature baby born at &lt;33 weeks gestation.&#xD;
  &#xD;
        Objectives:&#xD;
  &#xD;
          1. To assess baseline fathers' experiences in the NU, their involvement in FICare, and MH&#xD;
             status during babies NU admission up to 6 weeks post-discharge&#xD;
  &#xD;
          2. To conduct systematic review (SR) of published articles on 'Fathers and FiCare in NU'&#xD;
             and 'Fathers' MH in the NU'.&#xD;
  &#xD;
          3. To develop a programme to enhance involvement of fathers in FiCare.&#xD;
  &#xD;
          4. To introduce the programme developed to enhance fathers' involvement in FiCare and&#xD;
             explore their experiences and effect on their MH.&#xD;
  &#xD;
        Methods&#xD;
  &#xD;
        Study design:&#xD;
  &#xD;
        This is a prospective multi-centre and multi-phase pilot study. Phase 1 will assess baseline&#xD;
        fathers' experiences in the NU, their involvement in FICare and MH status during babies' NU&#xD;
        admission up to 6 weeks post-discharge. Simultaneously, a systematic review of fathers'&#xD;
        involvement in FICare and their MH outcomes will be conducted. A programme to enhance the&#xD;
        involvement of fathers in FICare will be developed using information from phase-1 study,&#xD;
        systematic review, existing DadPad app and advice from parent advisory group (PAG). In&#xD;
        phase-2 study, enhanced father involvement programme in FICare will be implemented and&#xD;
        similar assessments as in phase-1 will be conducted (Figure 1). Regular debrief sessions, and&#xD;
        research updates/newsletters to keep staff engaged and supportive of the project will be&#xD;
        provided. This support will be continued throughout the study.&#xD;
  &#xD;
        Study Centres: The study will be conducted at a tertiary neonatal unit (level 3) and a local&#xD;
        neonatal unit (level 2) as defined by the Department of Health, from East London, UK. The&#xD;
        Parent Advisory Group (PAG) will help to update the existing Neonatal DadPad app and booklet.&#xD;
        They will provide support in finalising topic guides for fathers' education classes for&#xD;
        phase-2 study. The PAG will also support in dissemination of the study findings to research&#xD;
        participants and the wider neonatal community.&#xD;
  &#xD;
        Phase 1 study. Baseline Data Collection: 9 months&#xD;
  &#xD;
          1. Prior to the introduction of the study to wider NU clinical staff members, staff&#xD;
             knowledge, experiences and opinions about the role of fathers and FICare will be&#xD;
             assessed by a questionnaire.&#xD;
  &#xD;
          2. Once a parent is recruited, the Parental Stressor Scale: NICU (PSS:NICU)20, and MH&#xD;
             questionnaires (Generalised Anxiety Disorder Assessment (GAD-7)21 and, Patient Health&#xD;
             Questionnaire (PHQ-922)) will be given to complete within 7 days.&#xD;
  &#xD;
          3. Fathers/partners will be invited to participate in 2 semi-structured interviews, within&#xD;
             2 weeks of recruitment and immediately prior to discharge. The interviews will explore&#xD;
             their MH, experiences of bonding with baby, understanding the neonatal environment, and&#xD;
             reflecting on their service expectations. Based on father's/partner's preference,&#xD;
             interviews will be undertaken either in a private room on the NU or virtually via MS&#xD;
             Teams at a mutually convenient time. Interviews will be digitally recorded and are&#xD;
             anticipated to last up to one hour. Data saturation is expected at around 12-15 fathers.&#xD;
  &#xD;
          4. The parents will be asked to complete the PSS:NICU, GAD7 and PHQ9 questionnaires at 3&#xD;
             weekly intervals, finishing on the week of discharge, to monitor their MH through their&#xD;
             NU stay.&#xD;
  &#xD;
          5. Up to 4 groups of 5 mothers will be invited to participate in a focus group to assess&#xD;
             their wellbeing, experience of the NU and their perspective on support for and from&#xD;
             their partners. This will occur in a room in the NU at a time convenient to the mothers.&#xD;
             Groups will be organised until data saturation is reached.&#xD;
  &#xD;
          6. Telephone/online questionnaires will be completed by parents at 4-6 weeks post-discharge&#xD;
             to assess family confidence and bonding after NU discharge.&#xD;
  &#xD;
        Washout, Phase 2 Preparation: 4 months&#xD;
  &#xD;
          1. The existing Neonatal DadPad app/booklet (which is currently used in several NHS Trusts&#xD;
             to guide fathers through their NU journey) will be updated using phase-1 and systematic&#xD;
             review study findings with guidance from the PAG, and a programme to enhance father&#xD;
             participation within the FICare model will be developed.&#xD;
  &#xD;
          2. Teaching sessions undertaken to educate and upskill all clinical NU staff on study aims,&#xD;
             recruitment, phase-1 study findings and upcoming phase-2 study, highlighting the&#xD;
             importance of fathers' role in the FICare (e.g., teaching parents how to safely give&#xD;
             nasogastric feeds, nappy changes in a ventilated baby).&#xD;
  &#xD;
        Phase 2 study. Enhanced Father involvement in FICare: 9 months. Once a family is recruited,&#xD;
        the programme developed to enhance father involvement in FICare will be implemented to take&#xD;
        place at the parents' pace. The NU experience and MH status of both parents will be assessed&#xD;
        as in phase-1 study. At the end of phase-2 study, staff knowledge, experiences and opinions&#xD;
        about fathers and FICare will be re-assessed and compared to the start of the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Anticipated">October 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Family-Based</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Paternal mental health</measure>
      <time_frame>From 1st week of baby's admission to discharge from the Neonatal Unit, up to 22 weeks</time_frame>
      <description>Fathers' mental stress is assessed by semi-structured interviews.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fathers care giving ability</measure>
      <time_frame>From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge</time_frame>
      <description>This will be assessed through semi-structured interview process.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental enagement</measure>
      <time_frame>6 weeks post baby discharge from Neonatal Unit</time_frame>
      <description>This will be assessed by telephone interview at 6 weeks after baby's discharge fromneonatal unit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal mental health</measure>
      <time_frame>From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge</time_frame>
      <description>Maternal stressor will be assessed by the PSS:NICU questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Paternal mental health</measure>
      <time_frame>From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge</time_frame>
      <description>Parental stressor will be assessed by the PSS:NICU questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Paternal anxiety</measure>
      <time_frame>From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge</time_frame>
      <description>Paternal anxiety will be assessed by Generalised Anxiety Disorder Assessment-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Paternal depression</measure>
      <time_frame>From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge</time_frame>
      <description>Paternal depression will be assessed by the Personal Health Questionnaire-9</description>
    </secondary_outcome>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Mental Health Wellness 1</condition>
    <condition>Premature Birth</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Babies born between 22+0 and 32+6 weeks who have two main caregivers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Parents of preterm infants will be recruited to the study.&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            1. Parents of 22+0 to 32+6 weeks preterm infants.&#xD;
  &#xD;
            2. Infant from day one to 7 days of age.&#xD;
  &#xD;
            3. Infant should have two primary caregivers. Father's/Partner's participation in the&#xD;
               study is a must and participation from both parents is ideal.&#xD;
  &#xD;
            4. The parents should have conversational English.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Infant with life-limiting condition or no realistic chance of survival.&#xD;
  &#xD;
            2. Infant is likely to be transferred to non-participating centre within 4 weeks of age.&#xD;
  &#xD;
            3. Parents under the age of 16 years.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Narendra Aladangady, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Homerton Healthcare NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rupa Rubinstein, MRCPCH</last_name>
      <phone>02085105555</phone>
      <email>rupa.rubinstein@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Narendra Aladangady, PhD</last_name>
      <phone>02085105555</phone>
      <email>n.aladangady@nhs.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Neonatal Unit, Whipps Cross University Hospital</name>
        <address>
          <city>London</city>
          <zip>E11 1NR</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>John Ho, FRCPCH</last_name>
        <phone>020 8539 5522</phone>
        <email>john.ho3@nhs.net</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Neonatal Unit, Homerton University Hospital</name>
        <address>
          <city>London</city>
          <zip>E9 6SR</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Narendra Aladangady, PhD</last_name>
        <phone>02085105555</phone>
        <phone_ext>7360</phone_ext>
        <email>n.aladangady@nhs.net</email>
      </contact>
      <contact_backup>
        <last_name>Rupa Rubinstein, MRCPCH</last_name>
        <phone>02085105555</phone>
        <phone_ext>7361</phone_ext>
        <email>rupa.rubinstein@nhs.net</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2022</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Father/partner wellbeing</keyword>
    <keyword>Maternal wellbeing</keyword>
    <keyword>Paternal infant engagement</keyword>
    <keyword>NICU</keyword>
    <keyword>Family integrated care (FICare)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Premature Birth</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Anonymised data only collected</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022991
  org study id: 152449
  nct id: NCT06022991
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  AIMS: The primary aim is to investigate the impact of enhancing father/partner engagement in
        FICare of preterm infants on their mental health (MH) up to 6 weeks post discharge. Secondary
        aims are to investigate the impact on maternal MH.
  
        METHOD and ANALYSIS: This is a two-phase study: Phase-1 to gather baseline information and
        Phase-2 to assess the impact of improved father/partner engagement in FICare involving two
        NUs (a tertiary and level 2). 20 families of infants born at <33 weeks will be studied in
        each phase (40 fathers, 40 mothers, 40 babies).
  
        Father/partner MH will be assessed using validated questionnaires: Generalised Anxiety
        Disorder Assessment (GAD-7), Patient Health Questionnaire (PHQ-9), Parental Stressor Scale:
        NICU (PSS:NICU), and by semi-structured qualitative interviews. Similarly, mothers will be
        assessed by the same questionnaires and focus groups.
  
        The Neonatal DadPad materials will be updated using information from phase 1 study,
        systematic review of Fathers experiences of FICare and advice from parent advisory group.
        Father's engagement in FICare will be enhanced using Neonatal DadPad information booklet and
        app, father-specific peer support and bitesize teaching on caring for NU babies (Phase 2).
  
        Thematic analysis of the qualitative data will be performed. Phase 1 and Phase 2 study
        findings will be compared by performing appropriate statistical analysis.
  BACKGROUND: Family-integrated care (FIC) is a culture whereby parents are viewed as
        collaborators in their baby's care in neonatal units. This can be challenging for
        fathers/non-birthing partners as they face competing demands on their time to try and allow
        the mother to focus on her baby.
  
        KEY AIMS AND OBJECTIVES:
  
        Aims To undertake an in-depth longitudinal study of the engagement of fathers/partners in
        FiCare and their experience and mental health (MH) from neonatal unit admission to 6 weeks
        post discharge of their premature baby born at <33 weeks gestation.
  
        Objectives:
  
          1. To assess baseline fathers' experiences in the NU, their involvement in FICare, and MH
             status during babies NU admission up to 6 weeks post-discharge
  
          2. To conduct systematic review (SR) of published articles on 'Fathers and FiCare in NU'
             and 'Fathers' MH in the NU'.
  
          3. To develop a programme to enhance involvement of fathers in FiCare.
  
          4. To introduce the programme developed to enhance fathers' involvement in FiCare and
             explore their experiences and effect on their MH.
  
        Methods
  
        Study design:
  
        This is a prospective multi-centre and multi-phase pilot study. Phase 1 will assess baseline
        fathers' experiences in the NU, their involvement in FICare and MH status during babies' NU
        admission up to 6 weeks post-discharge. Simultaneously, a systematic review of fathers'
        involvement in FICare and their MH outcomes will be conducted. A programme to enhance the
        involvement of fathers in FICare will be developed using information from phase-1 study,
        systematic review, existing DadPad app and advice from parent advisory group (PAG). In
        phase-2 study, enhanced father involvement programme in FICare will be implemented and
        similar assessments as in phase-1 will be conducted (Figure 1). Regular debrief sessions, and
        research updates/newsletters to keep staff engaged and supportive of the project will be
        provided. This support will be continued throughout the study.
  
        Study Centres: The study will be conducted at a tertiary neonatal unit (level 3) and a local
        neonatal unit (level 2) as defined by the Department of Health, from East London, UK. The
        Parent Advisory Group (PAG) will help to update the existing Neonatal DadPad app and booklet.
        They will provide support in finalising topic guides for fathers' education classes for
        phase-2 study. The PAG will also support in dissemination of the study findings to research
        participants and the wider neonatal community.
  
        Phase 1 study. Baseline Data Collection: 9 months
  
          1. Prior to the introduction of the study to wider NU clinical staff members, staff
             knowledge, experiences and opinions about the role of fathers and FICare will be
             assessed by a questionnaire.
  
          2. Once a parent is recruited, the Parental Stressor Scale: NICU (PSS:NICU)20, and MH
             questionnaires (Generalised Anxiety Disorder Assessment (GAD-7)21 and, Patient Health
             Questionnaire (PHQ-922)) will be given to complete within 7 days.
  
          3. Fathers/partners will be invited to participate in 2 semi-structured interviews, within
             2 weeks of recruitment and immediately prior to discharge. The interviews will explore
             their MH, experiences of bonding with baby, understanding the neonatal environment, and
             reflecting on their service expectations. Based on father's/partner's preference,
             interviews will be undertaken either in a private room on the NU or virtually via MS
             Teams at a mutually convenient time. Interviews will be digitally recorded and are
             anticipated to last up to one hour. Data saturation is expected at around 12-15 fathers.
  
          4. The parents will be asked to complete the PSS:NICU, GAD7 and PHQ9 questionnaires at 3
             weekly intervals, finishing on the week of discharge, to monitor their MH through their
             NU stay.
  
          5. Up to 4 groups of 5 mothers will be invited to participate in a focus group to assess
             their wellbeing, experience of the NU and their perspective on support for and from
             their partners. This will occur in a room in the NU at a time convenient to the mothers.
             Groups will be organised until data saturation is reached.
  
          6. Telephone/online questionnaires will be completed by parents at 4-6 weeks post-discharge
             to assess family confidence and bonding after NU discharge.
  
        Washout, Phase 2 Preparation: 4 months
  
          1. The existing Neonatal DadPad app/booklet (which is currently used in several NHS Trusts
             to guide fathers through their NU journey) will be updated using phase-1 and systematic
             review study findings with guidance from the PAG, and a programme to enhance father
             participation within the FICare model will be developed.
  
          2. Teaching sessions undertaken to educate and upskill all clinical NU staff on study aims,
             recruitment, phase-1 study findings and upcoming phase-2 study, highlighting the
             importance of fathers' role in the FICare (e.g., teaching parents how to safely give
             nasogastric feeds, nappy changes in a ventilated baby).
  
        Phase 2 study. Enhanced Father involvement in FICare: 9 months. Once a family is recruited,
        the programme developed to enhance father involvement in FICare will be implemented to take
        place at the parents' pace. The NU experience and MH status of both parents will be assessed
        as in phase-1 study. At the end of phase-2 study, staff knowledge, experiences and opinions
        about fathers and FICare will be re-assessed and compared to the start of the study.
  observational model: Family-Based
  time perspective: Prospective
  measure: Paternal mental health
  time frame: From 1st week of baby's admission to discharge from the Neonatal Unit, up to 22 weeks
  description: Fathers' mental stress is assessed by semi-structured interviews.
  measure: Fathers care giving ability
  time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
  description: This will be assessed through semi-structured interview process.
  measure: Parental enagement
  time frame: 6 weeks post baby discharge from Neonatal Unit
  description: This will be assessed by telephone interview at 6 weeks after baby's discharge fromneonatal unit.
  measure: Maternal mental health
  time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
  description: Maternal stressor will be assessed by the PSS:NICU questionnaire
  measure: Paternal mental health
  time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
  description: Parental stressor will be assessed by the PSS:NICU questionnaire.
  measure: Paternal anxiety
  time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
  description: Paternal anxiety will be assessed by Generalised Anxiety Disorder Assessment-7
  measure: Paternal depression
  time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
  description: Paternal depression will be assessed by the Personal Health Questionnaire-9
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Narendra Aladangady, PhD
  role: Study Director
  affiliation: Homerton Healthcare NHS Foundation Trust
  last name: Rupa Rubinstein, MRCPCH
  phone: 02085105555
  email: rupa.rubinstein@nhs.net
  last name: Narendra Aladangady, PhD
  phone: 02085105555
  email: n.aladangady@nhs.net
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Premature Birth
  sharing ipd: No
  ipd description: Anonymised data only collected