跳至主要内容
临床试验/NCT04519229
NCT04519229Enrolling By Invitation不适用

Child-Parent Psychotherapy for Children 0-6 Years Old With Experiences of Adverse Life Events - a Feasibility Study for Children in Foster Care

Kronoberg County Council1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
20
试验地点
1
主要终点
Change from baseline score on the Strengths and Difficulties Questionnaire - Parent version at 20 completed sessions or at termination of intervention if terminated earlier.

研究概览

简要总结

Children in foster care have an increased risk of exposure to adverse experiences during childhood and across the lifespan. In current studies of interventions children in foster care are often excluded, or they are too few to be included in statistical analyses of outcomes. As a consequence, knowledge on feasibility of treatment methods for some of the most exposed and maltreated children in society is sparse.

Child-Parent Psychotherapy (CPP) is an intervention for children 0-6 years who have been exposed to adverse and traumatic events. CPP is currently being implemented in Sweden. The aim of this study is to investigate the feasibility of CPP for children in foster care.

详细描述

Aim. The aim of the current study is to investigate the feasibility of CPP for young children who have an increased risk of exposure to adverse and traumatic experiences with negative effects on their health and development. Feasibility will be conceptualized as acceptance of the method by therapists, caregivers, and children; practical applications of the method; any need for modifications; and observed outcomes.

Research questions The main research question is: Is CPP feasible for children in foster care? Additional research questions are: 1) How do children in foster care experience participating in CPP? 2) How do foster parents experience participating in CPP? 3) How do clinicians experience using CPP with children in foster care and their caregivers? 4) What outcomes can be observed in treatment with children in foster care in terms of increased psychological health in children and foster parents; decrease in symptoms of post-traumatic stress in children and foster parents; and foster parents' experiences of their caregiving capacity and relationship with the child.

Method Design. The project has a naturalistic mixed-methods study design. Qualitative and quantitative research methods will be used to collect and analyze data. Qualitative data concerning childrens', caregivers', and clinicians' experiences of the treatment method as well as quantitative data concerning practical applications of the method, any modifications made, and reported levels of symptoms will be studied.

Participants. Nine agencies in different regions of Sweden offering CPP as part of their regular services have accepted to participate in the study. Participants are consecutively recruited at the participating agencies. Inclusion will be terminated when 20 children have been included (whereof at least 12 children aged 3-6 years).

Procedure. At treatment start caregivers and custodians (this can include foster parents, social services, and biological parents) will be informed about the study and asked for consent to participate. Because of their low age children aged 3-6 will be informed and asked for consent to participate in connection to the interviews. Quantitative data will be collected by self-report instruments completed by the foster parents before treatment and after 20 sessions or at termination, if treatment if terminated earlier. Participation, fidelity, and modifications are registered by clinicians continuously. Foster parents and clinicians will be asked to schedule interviews by one of the researchers in the project after 20 sessions or at termination, if treatment if terminated earlier.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
0 Years 至 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age 0-6 years
  • •being offered Child-Parent Psychotherapy as part of their regular treatment

排除标准

  • •Families in need of translator for interviews.

研究组 & 干预措施

Children in fostercare in CPP-treatment

Children in foster care taking part in Child-Parent Psychotherapy

干预措施: Child-Parent Psychotherapy (Behavioral)

结局指标

主要结局

Change from baseline score on the Strengths and Difficulties Questionnaire - Parent version at 20 completed sessions or at termination of intervention if terminated earlier.

时间窗: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

Caregiver report of child psychopathology. Minimum score 0, maximum score 40, higher score indicating worse outcome.

Change from baseline score on the Trauma Symptom Checklist for Young Children at 20 completed sessions or at termination of intervention if terminated earlier.

时间窗: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

Caregiver report of child symptoms of post-traumatic stress. Minimum score 90, maximum score 360, higher score indicating worse outcome.

Change from baseline score on the Linköping Youth Life Experiences Scale at 20 completed sessions or at termination of intervention if terminated earlier.

时间窗: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

Caregiver report of child exposure to traumatic and adverse life events. Minimum score 0, maximum score 41, higher score indicating worse outcome.

Change from baseline score on the Child-Parent Psychotherapy Symptom Screener at 20 completed sessions or at termination of intervention if terminated earlier.

时间窗: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

Caregiver report of child symptoms of post-traumatic reactions. Minimum score 0, maximum score 93, higher score indicating worse outcome.

次要结局

  • Change from baseline score on the Hopkins Symptom Check List-25 at 20 completed sessions or at termination of intervention if terminated earlier.(After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions)
  • Change from baseline score on the Impact of Event Scale-Revised at 20 completed sessions or at termination of intervention if terminated earlier.(After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions)
  • Change from baseline score on the Life Incidence of Traumatic Events Questionnaire at 20 completed sessions or at termination of intervention if terminated earlier.(After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions)
  • Change from baseline score on the Caregiving Helplessness Questionnaire at 20 completed sessions or at termination of intervention if terminated earlier.(After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions)

研究者

发起方
Kronoberg County Council
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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