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临床试验/NCT06003582
NCT06003582进行中(未招募)不适用

Partnership for Change - Co-production and Feasibility Randomised Controlled Trial of an Intervention to Improve the Mental Health of Children With a Social Worker

University of Glasgow1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Recruitment rates to a feasibility RCT

研究概览

简要总结

Feasibility RCT to ask: Can the investigators coproduce, with parent collaborators, a new service, Infant Parent Support (IPS), to improve the mental health of children with a social worker? Can the investigators test the feasibility of an RCT of IPS compared with services as usual?

详细描述

Questions addressed: Can the investigators coproduce, with parent collaborators, a new service, Infant Parent Support (IPS), to improve the mental health of children with a social worker? Can the investigators test the feasibility of an RCT of IPS compared with services as usual?

Considered for entry: Parents of children aged 0-5 who have mental health concerns, social workers, and a multi-agency support plan.

Inclusion criteria: Any family in the Glasgow or Bromley trial sites with a child aged 0-5 years with mental health concerns, a social worker, and a multi-agency support plan.

Exclusion criteria: At the outset of the Trial there were no exclusion criteria.

Over the course of Phase 1, the following exclusion criteria have emerged:

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
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Any family in the Glasgow or Bromley trial sites with a child aged 0-5 years with mental health concerns, a social worker, and a multi-agency support plan.

排除标准

  • At the outset of the Trial there were no exclusion criteria. Over the course of Phase 1, the following exclusion criteria have emerged:
  • If the child has a Child Protection Plan or is on the Child Protection Register
  • If the family are in the process of 'stepping down' from a CPP or CPR
  • If the child is currently engaged in therapeutic work.

结局指标

主要结局

Recruitment rates to a feasibility RCT

时间窗: 6 months

The recruitment of 30 families to the Trial and the 15 families randomised to the new therapeutic intervention will be measured by recruitment rates.

Retention rates to a feasibility RCT

时间窗: 1 year

The proportion of the 15 families randomised to the new intervention who continue through the Trial will be measured by retention rates.

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

Helen Minnis

Professor Helen Minnis

University of Glasgow

研究点 (1)

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