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临床试验/NCT06701877
NCT06701877
已完成
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Enhancing Foster Care Relationships Through Attachment-Based Intervention: Protocol of SAFE FAMILY STUDY, a Randomized Controlled Trial of the Circle of Security Parenting® Program in France

Shankland Rebecca1 个研究点 分布在 1 个国家目标入组 70 人2024年10月10日

概览

阶段
不适用
干预措施
COSP Intervention Group
疾病 / 适应症
Parenting Sensitivity
发起方
Shankland Rebecca
入组人数
70
试验地点
1
主要终点
Caregiving composite questionnaire (CCQ)
状态
已完成
最后更新
上个月

概览

简要总结

Background: Children in out-of-home care constitute a vulnerable population often experiencing mental health challenges related to early adversity and placement disruptions. The Circle of Security Parenting® (COS-P) program is an attachment-based intervention designed to enhance carer sensitivity and reflective functioning, ultimately improving the quality of carer-child relationships.

Methods This study protocol follows a mixed-methods randomized controlled trial evaluating the effectiveness of the COS-P program for foster carers in France. A total of 70 foster carers will be randomly assigned to either the intervention group (receiving COS-P in addition to Treatment as Usual) or the waitlist control group (receiving Treatment as Usual only). Quantitative measures, including the Caregiving Composite Questionnaire, Parenting Stress Index, and the Marschak Interaction Method, will be administered at baseline and at follow-up). Qualitative data will be collected through focus groups with foster carers and COS-P facilitators, and through self-confrontation interviews with a subset of foster carers.

Discussion: This study is the first to evaluate COS-P for foster carers in France. Findings will provide valuable insights into the program's effectiveness in improving carer-child relationships and foster carer well-being, ultimately contributing to better outcomes for children in out-of-home care. The study will also explore potential moderators of treatment outcome and shed light on the subjective experiences of participants.

注册库
clinicaltrials.gov
开始日期
2024年10月10日
结束日期
2025年12月1日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Shankland Rebecca
责任方
Sponsor Investigator
主要研究者

Shankland Rebecca

Full Professor of health and developmental psychology

Université Lumière Lyon 2

入排标准

入选标准

  • Foster carers:
  • Signed informed consent form.
  • Commitment to attend all eight sessions of the COS-P program.
  • Employed by CPS Haute-Loire or by one of the two participating private agencies.
  • Foster children:
  • Placed with a foster carer participating in the study.
  • Aged from 1 to 6 years.
  • In permanent placement (5 or more days per week with the foster carer).
  • Consent obtained from all individuals holding parental responsibility.

排除标准

  • 未提供

研究组 & 干预措施

COSP Intervention Group

The intervention group will participate in the COS-P program in addition to TAU. Foster carers will be assigned to groups of 8 to 10 participants and will attend sessions in dedicated training facilities.

Waitlist control group

Waitlist control groupe will continue to receive Treatment as Usual (TAU), which consists of Psycho-Educational Support (PSE) provided by Child Protection Services. PSE typically involves home visits, educational and psychological support for foster carers and/or children in placement, and efforts to support and monitor contact between children and their birth families. The control group will be placed on a waiting list to receive the COS-P program as part of continuing education at a later date.

干预措施: Traitement as usual (TAU)

结局指标

主要结局

Caregiving composite questionnaire (CCQ)

时间窗: at baseline and at 3 month f/u

The CCQ is a 43-item self-report measure specifically designed to assess parent capacities targeted by the COS-P program, namely: parental mentalizing, parenting self-efficacy, and parent perceptions of the child. It combines six subscales and one single item drawn from previously validated measures, retaining the original response formats and scoring procedures for each subscale. The CCQ has demonstrated good reliability and validity in a pilot sample of parents and is being used in the current study to assess the impact of COS-P on these key parenting capacities.

Parent Development Interview-Revised

时间窗: At baseline and at 3-month f/u

This semi-structured interview consists of 31 questions, administered in approximately one hour, covering four domains: (a) perception of the child, (b) perception of the relationship, (c) parental affective experience, and (d) separation experiences.

次要结局

  • Parenting Stress Index - IV - Short Form (PSI)(At baseline and 3-month f/u)
  • Marschak Interaction Method (MIM)(At baseline and 3-month f/u)

研究点 (1)

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