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临床试验/NCT05148260
NCT05148260尚未招募不适用

Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for Depressed British Mothers of African and Caribbean Origin

Nottingham Trent University0 个研究点目标入组 80 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Change in postnatal depression is being assessed

研究概览

简要总结

By 2030, depression will be the leading global disease burden. Postnatal depression due to childbirth/parenting leads to long-term negative consequences for mothers, their children and their families. The British African/Caribbean communities are worse hit by the unprecedented impact of post-Covid-19-syndromes, leading to an exponential increase in postnatal depression. Yet, the uptake of mental healthcare by British mothers of African and Caribbean origin is low due to limited access to culturally appropriate care. Theories of attachment and cognitivism were innovatively integrated to examine Learning-Through-Play plus (LTP+) intervention for postnatal depression using a pilot randomised controlled trial. The proposed LTP+ is co-developed and ecologically friendly because it is manualised and can be delivered by non-mental health specialists such as trained community health workers who are more culturally knowledgeable. Findings will be disseminated through academic publications/presentations, policy briefs, original animated videos and podcast series laying the foundations for a psychosocial approach to tackling postnatal depression

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in postnatal depression is being assessed

时间窗: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)

Change in postnatal anxiety is being assessed

时间窗: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale

Change in social support is being assessed

时间窗: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Primary outcome measures would be assessed using the Oslo Social Support Scale

Change in health-related quality of life is being assessed

时间窗: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)

Change in service satisfaction is being assessed

时间窗: Change is being assessed at 12 weeks end of intervention

Outcome measure would be assessed using the brief Verona Service Satisfaction Scale

Change in child physio-emotional development is being assessed

时间窗: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire

Change in parenting knowledge of child development is being assessed

时间窗: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Outcome measure would be assessed using Learning Through Play Knowledge, Attitude and Practices (KAP) Questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Dung Jidong, PhD

Senior Lecturer

Nottingham Trent University

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