'Nurture and Play' - a Randomized Controlled Pilot Study of a Perinatal Intervention to Strengthen Parenting Among Women with Psychosocial Vulnerabilities and Their Partners.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- The feasibility of the NnP including both parents (The recruitment procedure and the adherence to the intervention)
研究概览
简要总结
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.
Data will be collected through:
- Online Questionnaires.
- Interviews.
- Videotaped settings.
详细描述
Protocol
Title 'Nurture and Play' - a randomized controlled pilot study of a perinatal intervention to strengthen parenting among women with psychosocial vulnerabilities and their partners.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known with a current or previous history of anxiety and/or depression
- •Referred for labour at Slagelse Hospital
排除标准
- •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
结局指标
主要结局
The feasibility of the NnP including both parents (The recruitment procedure and the adherence to the intervention)
时间窗: 1 year
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?
The participant's and professional´s experience of the intervention as well as the collaboration between the hospitals and the municipalities.
时间窗: Approximately 30 minutes per interview
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.
次要结局
未报告次要终点