The Effect of the Close Collaboration With Parents Intervention - Estonian Study

NCT06258655 | Completed

• 1 other identifier: SA332962
• Study Type: interventional
• Target: 622
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to implement an evidence-based intervention called 'Close Collaboration with Parents' in Estonian neonatal units. The goal of the intervention is to educate the whole multi-professional NICU staff and promote a positive change in the family-centered care culture of the units. Thus, the first aim of the study is to implement the intervention in an Estonian NICU context, in three hospitals, and study the fidelity of the intervention. More precisely, the study questions are whether adaptations are needed for the successful implementation of the intervention in the Estonian context and how feasible are the used implementation strategies. Secondly, the aim is to study the effectiveness of the Close Collaboration with Parents intervention in this context by using a quasi-experimental, pre-test - post-test, study design. The questions are whether the implementation of the intervention in the Estonian setting will result in positive effects such as 1) an improved development environment for the infants during hospital stay (less noise, more parental speech, and more parent-infant physical closeness), 2) intensified parental bonding to the infant, and 3) increased parental confidence and emotional well-being at the time of discharge from hospital.

Conditions

Depression, Postpartum; Anxiety

Outcome Measures

Primary Outcomes (1)

• Depression

  The postnatal depressive symptoms of the mothers whose newborn has been cared for in the unit after the intervention are compared with the postnatal depressive symptoms of the mothers whose newborn has been cared for in the unit before the intervention. The symptoms are measured with Edinburgh Postnatal Depression Scale. The 10-question scale includes symptoms such as insomnia, mood, tearfulness, and thoughts of self-harm. The scale asks how a person has felt during the previous week. The minimum score is 0 and the maximum is 30. A high score indicates more depressive symptoms.

  Up to 2 months

Secondary Outcomes (1)

• Anxiety

  Up to 2 months

Other Outcomes (4)

• Parenting self-efficacy

  Up to 2 months

• Readiness for discharge

  Up to 2 months

• Family-centered care

  Up to 2 months

Study Arms (2)

Pre-intervention

NO INTERVENTION

The sample collected before the intervention

Post-intervention

EXPERIMENTAL

The sample collected after the intervention

Other: Close Collaboration with Parents

Interventions

Close Collaboration with Parents OTHER

The Close Collaboration with Parents intervention is an educational program for the neonatal staff to improve their skills to collaborate with parents and provide support to parenting during an infant's hospitalization. First, experienced nurses and doctors from the units will undergo a 14-day to become "unit mentors". Then these unit mentors will train other members of staff. The training of the units is based on bedside practices, a reflection of the practices, and the application of the knowledge in everyday work. Theoretical learning, preceding clinical bedside mentoring, will occur through an e-learning module. Staff members will spend about 4 working days in training alongside their routine work. The unit mentors will function as facilitators for the staff, and they have dedicated time for this. The content of the bedside practices is guided by a manual. The training team will provide frequent remote and contact support for the implementation.

Post-intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• families whose newborns have been hospitalized during the first 28 days of infant life
• expected length of stay of the newborn is at least three days
• discharge is planned to happen within a week
• at least one parent has agreed to participate in the study
• \) Not able to communicate in Estonian, Russian, or English.
• \) The staff working in the units during the entire study period are eligible for the study.

Sponsors & Collaborators

• University of Turku: lead
• University of Tartu: collaborator

Study Sites (1)

Sari Ahlqvist-Björkroth

Turku, 20014, Finland

Location

Related Publications (1)

• Itoshima R, Varendi H, Toome L, Saik P, Axelin A, Lehtonen L, Moazami-Goodarzi A, Ahlqvist-Bjorkroth S. Outcomes Following Close Collaboration With Parents Intervention in Neonatal Intensive Care Units: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2454099. doi: 10.1001/jamanetworkopen.2024.54099.

  PMID: 39786771 DERIVED

Related Links

• e-learning tool used in the intervention

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sari Ahlqvist-Björkroth, Assoc.Prof.

  University of Turku

  PRINCIPAL INVESTIGATOR

• Heili Varendi, Prof.

  University of Tartu and Tartu University Hospital

  STUDY DIRECTOR

• Liis Toome, MD

  Tallinn Children's Hospital

  STUDY CHAIR

• Pille Saik, MD

  West Tallinn Central Hospital

  STUDY CHAIR

• Liisa Lehtonen, Prof.

  University of Turku

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A quasi-experimental before and after intervention design

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 14, 2024
• Study Start: March 23, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)