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临床试验/NCT02151955
NCT02151955已完成不适用

Social-emotional Under 4's Screening & Intervention; A Study of Emotional Health and Development in Babies and Young Children

South London and Maudsley NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
1
主要终点
Keys to Interactive Parenting Scale (KIPS)

研究概览

简要总结

Following an exploratory project, funded by Guys and St Thomas' Charity between September 2010- November 2011, of the first combined mental health screening and intervention project for <5 Children in Care (CiC) in the UK, the current study will expand this work by a) developing a feasibility study to assess both longer term interventions and outcomes for this group and b) extending the model to two further vulnerable groups of young children.

The three groups of children aged 3 months to 3 years (<4's) in Southwark include:

  1. Children who become newly looked after (CiC)
  2. Children of parents referred to Parental Mental Health team (PMH)
  3. Children on Child Protection (CP) Plans

Parents will be invited to take part in the study if their children are eligible within the groups above. Informed consent will be obtained at the outset.

Hypothesis;

The investigators aim to implement a method of screening that will identify socioemotional and mental health needs in infants and young children, aged 0-3 years of age, across three high risk cohorts (Children in Care, children on a Child Protection Plan, children of parents with mental health difficulties).

Is it feasible to deliver an early treatment intervention that positively impacts on the difficulties identified, by providing specific emotional, social and mental health support and advice to the child's current caregivers in relation to the child.

详细描述

The purpose of the feasibility study is to evaluate the impact of specific mental health interventions for the children, parents and carers in three high risk groups of children under the age of 4 years.

Recruitment This research will take place in the Carelink, CAMHS Looked after Children's team.

A brief introduction to the research will be sent with relevant appointment information to the parents in all groups stating that they may be approached by a researcher at a particular time (e.g at a scheduled Contact, a CP conference, appointment with their keyworker). The letter will say that the researcher will be making contact to discuss details of the research at an agreed and convenient date for the parents. It will make clear that participation is voluntary. We have made the letter as brief and clear as possible because parents may have difficulty processing information like this at a stressful time.

If the birth parents agree to meet with a CAMHS research practitioner, it will give them an opportunity to ask any questions and to discuss the study in detail to facilitate informed consent. Also at the meeting we will set up a time for the first screening visit to take place once parent have confirmed their participation.

We will inform all keyworkers when a family gives informed consent to participate in the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Months 至 4 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children who have newly come into care (CiC) where their parents have given informed consent and foster carers have given informed consent
  • •Children whose parents have been referred to the Parental Mental Health team (PMH) where parents have been assessed by the PMH team and are engaged with an identified parental mental health worker.
  • •Children who are new to a Child Protection Plan where their parents have given informed consent

排除标准

  • •Children who have newly come into care (CiC) whose foster carers live so far away geographically as to make it impractical to deliver the intervention.
  • •children whose families have been offered a place in the Family Drug and Alcohol Service.
  • •when English language is not sufficient to engage in intervention.

研究组 & 干预措施

Individual parent infant intervention

Experimental

Children and parents will be offered an assessment and then a tailored individual 10 to 15 week based attachment and parent intervention to promote parent child relationship.

干预措施: Individual (Behavioral)

结局指标

主要结局

Keys to Interactive Parenting Scale (KIPS)

时间窗: Participants will be assessed at baseline and at 26 weeks

The main outcome measure that will be used to determine the acceptability and feasibility of the screening and intervention across all three of our high risk groups is the Keys to Interactive Parenting Scale (KIPS, 2011). KIPS is a reliable, evidence based tool to effectively measure parenting behaviours. Twelve aspects of parenting (e.g. sensitivity of responses, physical interaction, involvement in child's activities, adapts strategies to child) are rated on a 5 point scale, following a 20 minute observation of the parent or carer interacting with the child.

次要结局

  • Child and Adolescent Service use Schedule (CASUS)(Participants will be assessed at baseline and at 26 weeks)
  • The Ages and stages Questionnaire Social Emotional (ASQ:SE 2003)(Participants will be assessed at baseline and at 26 weeks)
  • Representational measures of Mindmindedness in preschoolers (Meins, 1998)(Participants will be assessed at baseline and at 26 weeks)

研究者

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

Elizabeth Murphy

Consultant Child & Adolescent Psychotherapist

South London and Maudsley NHS Foundation Trust

研究点 (1)

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