'Nurture and Play' - a Pilot Study

ConditionsDepression, Anxiety Intervention Randomized Controlled Study

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCenter for Clinical Research and Prevention

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Known with a current or previous history of anxiety and/or depression

Referred for labour at Slagelse Hospital

Disqualifiers

Age under 18 years old

A need for an interpreter

Expecting more than one child

Known with schizophrenia or other serious mental illness

Trial design

Design model

Parallel

Treatments tested in this trial

Nurture and Play (NnP)
Behavioral
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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: The intervention group - The Nurture and Play group programExperimental treatment 1 intervention

Group B: The control group - Care as UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

The feasibility of the NnP including both parents (The recruitment procedure and the adherence to the intervention)

How is the intervention or service being delivered? Is it being delivered as intended? How does the actual delivery of the intervention or service differ from what was initially expected? What factors influence delivery and how? What are the difficulties faced in delivery? What are practitioners' experiences of delivering the intervention? What are the perceived supporting factors or barriers to effective delivery? How successful, or not, has it been at recruiting participants and why? Has the recruitment strategy been successful in reaching intended participants for the intervention? How successful or not has it been at retaining participants, and why? Did the participants find the intervention engaging and useful? To what extent has it reached its intended audience?

Time frame

1 year

The participant's and professional´s experience of the intervention as well as the collaboration between the hospitals and the municipalities.

Interviews. The interviews will be performed online, by phone, in the participants' homes or at the hospital - according to the participant's preferences. Data will be analyzed using Reflexive thematic analysis by Braun and Clark, 2019.

Time frame

Approximately 30 minutes per interview

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center for Clinical Research and Prevention

Lead sponsor

University of Copenhagen

Collaborator

Slagelse Sygehus