Mental Health Wellness 1TARGETNCT06022991
Fathers and Partners in Family Integrated Care Study
An observational study of Mental Health Wellness 1 and Premature Birth, run by Homerton University Hospital NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Health Wellness 1, Premature Birth
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Nov 2022to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Babies born between 22+0 and 32+6 weeks who have two main caregivers
Who may be able to join
- Parents of 22+0 to 32+6 weeks preterm infants.
- Infant from day one to 7 days of age.
- Infant should have two primary caregivers. Father's/Partner's participation in the study is a must and participation from both parents is ideal.
- The parents should have conversational English.
Who cannot join
- Infant with life-limiting condition or no realistic chance of survival.
- Infant is likely to be transferred to non-participating centre within 4 weeks of age.
- Parents under the age of 16 years.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Neonatal Unit, Whipps Cross University Hospital
London, E11 1NR
John Ho, FRCPCH, 020 8539 5522, john.ho3@nhs.net
- Recruiting
Neonatal Unit, Homerton University Hospital
London, E9 6SR
Narendra Aladangady, PhD, 02085105555 ext. 7360, n.aladangady@nhs.net
Rupa Rubinstein, MRCPCH, 02085105555 ext. 7361, rupa.rubinstein@nhs.net
About this study
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
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).
Read more
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.
Read the detailed description
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:
- 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
- To conduct systematic review (SR) of published articles on 'Fathers and FiCare in NU' and 'Fathers' MH in the NU'.
- To develop a programme to enhance involvement of fathers in FiCare.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Conditions
- Mental Health Wellness 1, Premature Birth
- Keywords
- Father/partner wellbeing, Maternal wellbeing, Paternal infant engagement, NICU, Family integrated care (FICare)
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Paternal mental health
Fathers' mental stress is assessed by semi-structured interviews.
Measured: From 1st week of baby's admission to discharge from the Neonatal Unit, up to 22 weeks
Secondary outcomes (6)
Fathers care giving ability
This will be assessed through semi-structured interview process.
Measured: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Parental enagement
This will be assessed by telephone interview at 6 weeks after baby's discharge fromneonatal unit.
Measured: 6 weeks post baby discharge from Neonatal Unit
Maternal mental health
Maternal stressor will be assessed by the PSS:NICU questionnaire
Measured: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Paternal mental health
Parental stressor will be assessed by the PSS:NICU questionnaire.
Measured: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Paternal anxiety
Paternal anxiety will be assessed by Generalised Anxiety Disorder Assessment-7
Measured: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Paternal depression
Paternal depression will be assessed by the Personal Health Questionnaire-9
Measured: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Nov 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Homerton University Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narendra Aladangady, PhD, Study director, Homerton Healthcare NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022991
- Sponsor's protocol ID
- 152449
- Acronym
- TARGET
- Status last verified
- Sep 2023
- First submitted
- 27 Jul 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data only collected
Publications
Rubinstein R, Gallagher K, Ho J, Bose J, Khashu M, Aladangady N. Investigating Father or Partner Involvement in Family Integrated Care in Neonatal Units: Protocol for a Prospective, Multicenter, Multiphase Study. JMIR Res Protoc. 2024 Mar 25;13:e53160. doi: 10.2196/53160.
PubMed 38526549
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06022991
- Acronym / sponsor ID
- TARGET / 152449
- Conditions
- Mental Health Wellness 1, Premature Birth
- Keywords
- Father/partner wellbeing, Maternal wellbeing, Paternal infant engagement, NICU, Family integrated care (FICare)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Homerton University Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 5 Sep 2023 (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.
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.
Detailed description
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:
- 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
- To conduct systematic review (SR) of published articles on 'Fathers and FiCare in NU' and 'Fathers' MH in the NU'.
- To develop a programme to enhance involvement of fathers in FiCare.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Babies born between 22+0 and 32+6 weeks who have two main caregivers
Key inclusion criteria (4 listed)
- Parents of 22+0 to 32+6 weeks preterm infants.
- Infant from day one to 7 days of age.
- Infant should have two primary caregivers. Father's/Partner's participation in the study is a must and participation from both parents is ideal.
- The parents should have conversational English.
Key exclusion criteria (3 listed)
- Infant with life-limiting condition or no realistic chance of survival.
- Infant is likely to be transferred to non-participating centre within 4 weeks of age.
- Parents under the age of 16 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Paternal mental health
Time frame: From 1st week of baby's admission to discharge from the Neonatal Unit, up to 22 weeks
Fathers' mental stress is assessed by semi-structured interviews.
6 secondary outcomes
Fathers care giving ability
Time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Parental enagement
Time frame: 6 weeks post baby discharge from Neonatal Unit
Maternal mental health
Time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Paternal mental health
Time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Paternal anxiety
Time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Paternal depression
Time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 38526549Rubinstein R, Gallagher K, Ho J, Bose J, Khashu M, Aladangady N. Investigating Father or Partner Involvement in Family Integrated Care in Neonatal Units: Protocol for a Prospective, Multicenter, Multiphase Study. JMIR Res Protoc. 2024 Mar 25;13:e53160. doi: 10.2196/53160.
- Individual participant dataSharing planned: No. Anonymised data only collected
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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.
Narendra Aladangady, PhD study director
Homerton Healthcare NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Wellness 1 and Premature Birth, run by Homerton University Hospital NHS Foundation Trust at 2 sites in United Kingdom.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Sep 2023. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rupa Rubinstein, MRCPCH (02085105555, rupa.rubinstein@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paternal mental health (time frame: From 1st week of baby's admission to discharge from the Neonatal Unit, up to 22 weeks). 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 NCT06022991, which also lists 1 linked publication.
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 5 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.