'Nurture and Play' - a Pilot Study

NCT06791876 | Not Yet Recruiting

• 1 other identifier: H-24058743
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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:
• 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.
• A qualitative descriptive interview study aiming to evaluate the participants' and professionals´ experience of the intervention.
• Online Questionnaires.
• Interviews.
• Videotaped settings.

Conditions

Depression, Anxiety; Intervention; Randomized Controlled Study

Outcome Measures

Primary Outcomes (2)

• 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?

  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.

  Approximately 30 minutes per interview

Study Arms (2)

The intervention group - The Nurture and Play group program

EXPERIMENTAL

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 prenatal and 11 postnatal sessions) and will be provided to parents in the intervention group from around pregnancy week 26 until the child is around seven months old. Each group will consist of four to five mothers/couples. The intervention will be delivered by midwives and health nurses who will receive training in conducting the program. The training for the professionals will be delivered by the Finish group which has developed the program and consists of four days of training - two days introductory and two days of training that will be given after some practice with the program.

Behavioral: Nurture and Play (NnP)

The control group - Care as Usual

NO INTERVENTION

The control group are offered a basic package of antenatal care consisting of three consultations with their general practitioner, two ultrasound examinations, and four to seven consultations with midwives depending on parity. Postnatal examinations of the infant are performed regularly by the health nurse in the infant's home. During the child's first year, the health nurse examines the infant at least twice within the first three weeks after birth, at two months, at four months (for first-time mothers) and again at eight months. Extra counselling home visits to vulnerable families after the infant is born are provided by health nurses in all municipalities with the number and content depending on families' specific needs.

Interventions

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.

The intervention group - The Nurture and Play group program

Eligibility Criteria

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

You may qualify if:

• Known with a current or previous history of anxiety and/or depression
• Referred for labour at Slagelse Hospital

You may not qualify if:

• Age under 18 years old
• A need for an interpreter
• Expecting more than one child
• Known with schizophrenia or other serious mental illness
• Expecting a child with a known illness
• A history of alcohol or drug abuse

Sponsors & Collaborators

• Center for Clinical Research and Prevention: lead
• University of Copenhagen: collaborator
• Slagelse Sygehus: collaborator

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Michaela Schiøtz, PhD

  Bispebjerg og Frederiksberg Hospitaler

  STUDY DIRECTOR

Central Study Contacts

Lotte Broberg, Ph.D

CONTACT

+45 2190 8188; lotte.broberg.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The parents who agree to participate in the study will be randomly assigned in a 1:1 ratio to either the intervention, Nurture and Play, or the control group, using random permuted block randomization

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 24, 2025
• Study Start: February 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: January 28, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share