The SUPPORTED Study - First-time Fathers of Preterm Infants.

NCT06116747 | Enrolling By Invitation DMC

• 1 other identifier: P-2022-792
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to support first-time fathers of premature infants in early parenthood by promoting early paternal-infant relationships. Improve paternal confidence by involving, knowledge sharing, and guiding them in their premature infants' emotional, nutritional, and developmental needs. The study operates with two study populations: a) first-time fathers, their premature infants, and families, b) health care professionals working with new families in neonatal intensive care units and maternity units and the families' health visitors from the secondary health care sectors. Seven hospitals located in Denmark's five regions participates. Four studies address the key questions for the father's involvement in supportive health care: 1) How do fathers experience their participation in father-groups in the NICU, 2) What are the first-time fathers' needs and preferences for supporting health care, 3) Development of an intervention based on the identified need to support the fathers in early parenting, 4) Study the process and effect of the intervention on paternal confidence and stress. The first question is explored in a qualitative evaluation of an ongoing father-group intervention in a neonatal intensive care unit. The following three questions are studied through an action research approach, identifying first-time fathers' needs for support and the current practices among health professionals towards new first-time fathers of premature infants. Secondly, developing guiding principles for health care professionals to strengthen fathers' partnership in health care. Finally, conducting a quasi-experimental study to evaluate the process and effect of the proposed approaches. The study of this paternal supportive programme, involves perspectives that have not yet been studied in Denmark or internationally.

Conditions

Preterm; Father-Child Relations

Keywords

Preterm; Father-Child relations

Outcome Measures

Primary Outcomes (1)

• Paternal confidence: Karitane Parenting Confidence Scale (KPCS),

  15 items, 0-1 year postpartum. (Črnčec et al., 2008, 2010).

  2 weeks, 4 month, 9 month corrected age

Secondary Outcomes (7)

• Infant social-emotional competence

  4 month, 9 month corrected age

• Depression

  2 weeks, 9 month corrected age

• FAD: Family Assessment Device

  4 month corrected age

• Paternal mentalizing competence: The Parental Reflective Functioning Questionnaire (PRFQ)

  4 month corrected age

• Exclusive breastfeeding direct from the breast (2 items)

  2 weeks, 4 month, 9 moths correced age

Study Arms (2)

No intervention Group

NO INTERVENTION

Group receiving care as usual

Intervention Group

EXPERIMENTAL

Complex Intervention under development in collaboration with fathers' health care professionals in primary and secondary sectors.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

Support for fathers of preterm infants

Intervention Group

Eligibility Criteria

• Gender Eligibility Details: First-time fathers and mothers of preterm infants
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• First-time fathers of preterm infants
• Co-habitating with the mother of the infant
• Neonatal Admission for more than seven days
• Danish language
• Infants born before the 37 week of gestation

You may not qualify if:

• Infant receiving palliative treatment and care
• parents not discharged for home
• parental mental illness

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Odense University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Holbaek Sygehus: collaborator
• Slagelse Hospital: collaborator
• Zealand University Hospital: collaborator
• Gødstrup Hospital: collaborator
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• University College Absalon: collaborator
• Lovisenberg Diakonale Hospital: collaborator

Study Sites (1)

Copenhagen University Hospital Amager Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Holm KG, Hagi-Pedersen MB, Haslund-Thomsen H, Nilsson I, Aagaard H, Maastrup R, Ejlertsen C, Petersen M, Feenstra MM, Kristensen I, Brodsgaard A. Protocol for the SUPPORTED study: a Danish multicentre complex intervention for first-time fathers of preterm infants. BMJ Open. 2025 Sep 15;15(9):e100258. doi: 10.1136/bmjopen-2025-100258.

  PMID: 40954083 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Methods

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Anne Brødsgaard

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intervention study with one control group and one intervention group

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 3, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)