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临床试验/ISRCTN12765736
ISRCTN12765736已完成未知

Enhancing maternal and infant wellbeing: A feasibility study of the Baby Triple P Positive Parenting Programme for mothers with severe mental health difficulties

niversity of Manchester0 个研究点目标入组 37 人开始时间: 2017年2月2日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
37

研究概览

简要总结

2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30201040/ protocol (added 27/11/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35651824/ (added 08/06/2022)

研究设计

研究类型
Interventional

入排标准

性别
Female

入选标准

  • Patient participants:
  • 1. Aged 18 years or more
  • 2. Have at least one infant aged birth to 12 months who they care for or are going to care for
  • 3. Are in the third trimester of pregnancy and are expected to reside on the MBU following delivery
  • 4. Are able to comprehend and understand English to provide consent to the study
  • 5. Are able to provide written informed consent. Note: MBU staff routinely assesses their capacity
  • Staff participants:
  • 1. Permanent full-time or part-time members of the Mother and Baby Unit (MBU) staff team
  • 2. Have worked on the MBU for at least six months
  • 3. Proficient in English to understand the study, provide written, informed consent and can take part in interviews

排除标准

  • Patient participants:
  • 1. Participants who do not have a sufficiently good working knowledge of English to provide written informed consent and understand and complete questionnaires. Use of interpreters is beyond the scope of this feasibility study, but could be built into a definitive trial. Note: If interpreters are involved in the routine care of a participant, then their inclusion can be considered.
  • 2. Participants whose current symptoms seriously compromise their ability to concentrate on the assessments or intervention sessions. Examples include participants who experience persistent and loud auditory hallucinations that they clearly react to. Eligibility can be reassessed once a participant’s acute symptoms subside.
  • 3. Participants who show severe personality disorder traits including significant current self-harming behaviours (such as attempting suicide). Note: MBU staff assess these behaviours as part of routine practice alongside risk issues.
  • 4. Participants whose infant will be removed from their care on a non-temporary basis
  • 5. Participants whose discharge has been scheduled within 7 days from date of recruitment
  • Staff participants:
  • 1. Nursing students or bank staff who work on the MBU on a temporary basis only.
  • 2. Have less than six months experience of working on the MBU.

研究者

发起方
niversity of Manchester

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