'Nurture and Play' - a Pilot Study

Summary

The aim of this randomised controlled pilot study is to evaluate the feasibility of the Nurture and Play (NnP) offered to a Danish population of psychosocial vulnerable pregnant women and their partners.

More specifically the objectives of the study are to:

* Test the feasibility of the NnP including both parents
* Evaluate the recruitment procedure, the adherence as well as the participant's and professional´s experience of the intervention
* Evaluate the collaboration between the hospitals and the municipalities.

The study consists of:

1. A randomized controlled pilot study (n=20 women/couples) carried out according to the Standard Protocol Items: Recommendations for Interventional Trials SPIRIT statement for clinical trials. The parents who agree to participate in the study will be randomly assigned in a 1:1 ratio to either the intervention or the control group. In addition to care-as-usual, the intervention group will be offered to participate in the NnP adapted to include partners. The intervention consists of 11 group sessions (4 perinatal and 7 postnatal sessions) and will be provided to the parents in the intervention group from around 26 weeks gestation until the baby is around seven months old. Each group session will be led by a midwife and a health nurse and will consist of four to five mothers/couples.
2. A qualitative descriptive interview study aiming to evaluate the participants' and professionals´ experience of the intervention.

Data will be collected through:

* Online Questionnaires.
* Interviews.
* Videotaped settings.

Conditions

• Depression, Anxiety
• Intervention
• Randomized Controlled Study

Interventions

BEHAVIORAL

Nurture and Play (NnP)

The NnP group Intervention is a group-based, manualized parenting intervention initiated during pregnancy and continued into the postnatal period until infant age seven months. The program is designed to enhance parenting abilities focusing on three domains: Emotional availability, parental reflective functioning, and the ability to regulate own emotions. During NnP, the parents are supported in enhancing their emotional availability through caring and playing activities. The intervention has been developed in Finland by Dr. Saara Salo and colleagues and tested in a randomized controlled trial among pregnant women with depression and it is now being implemented in Finland. The results from the study showed that mothers in the intervention group showed more emotional availability and higher levels of reflective functioning and experienced fewer depressive symptoms compared to mothers in the control group.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Slagelse Sygehus

  collaborator OTHER

• Center for Clinical Research and Prevention

  lead NETWORK

Principal Investigators

• Michaela Schiøtz, PhD · Bispebjerg og Frederiksberg Hospitaler

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-15

Primary Completion

2026-10-15

Completion

2026-10-15