Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
NCT05012072
Behavior, Female Urogenital Diseases and Pregnancy Complications
Webster, Texas, United States
View Trial DetailsNCT Number: NCT06022991
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.
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Observational
Neonatal Unit, Homerton University Hospital, London, United Kingdom
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:
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
Washout, Phase 2 Preparation: 4 months
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Parents of preterm infants will be recruited to the study.
Inclusion criteria
Exclusion criteria
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.
Time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
This will be assessed through semi-structured interview process.
Time frame: 6 weeks post baby discharge from Neonatal Unit
This will be assessed by telephone interview at 6 weeks after baby's discharge fromneonatal unit.
Time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Maternal stressor will be assessed by the PSS:NICU questionnaire
Time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Parental stressor will be assessed by the PSS:NICU questionnaire.
Time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Paternal anxiety will be assessed by Generalised Anxiety Disorder Assessment-7
Time frame: From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge
Paternal depression will be assessed by the Personal Health Questionnaire-9
Contact information is provided by the study sponsor or research team.
Narendra Aladangady, PhD
CONTACT
Rupa Rubinstein, MRCPCH
CONTACT
Homerton University Hospital NHS Foundation Trust
Other
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
Acronym: TARGET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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