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Completed

NCT Number: NCT06701877

Enhancing Foster Care Relationships Through Attachment-Based Intervention: Protocol of SAFE FAMILY STUDY

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.

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Key information

Conditions

Parenting Sensitivity Foster Care

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DEPARTEMENT de la Haute-Loire

Le Puy-en-Velay, France, 43000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

Circle of security Parenting (COS-P)

Behavioral

The Circle of Security Parenting® (COS-P) program is an attachment-based intervention designed to enhance caregiver sensitivity, parental reflective functioning, and the quality of the child's attachment to their caregiver. This manualized intervention, with both educational and therapeutic components, empowers caregivers to better understand and respond to their child's needs, fostering secure attachment (22).

Traitement as usual (TAU)

Behavioral

TAU 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.

Primary outcomes

  1. Caregiving composite questionnaire (CCQ)

    Time frame: 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.

  2. Parent Development Interview-Revised

    Time frame: 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.

Secondary outcomes

  1. Parenting Stress Index - IV - Short Form (PSI)

    Time frame: At baseline and 3-month f/u

    This 36-item questionnaire includes three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC). The 12 items of the P-CDI subscale will be used to assess foster carers' perceptions of their relationship with the child in their care, using a 5-point Likert scale.

  2. Marschak Interaction Method (MIM)

    Time frame: At baseline and 3-month f/u

    This structured assessment tool is based on attachment and mentalization theories and involves a series of age-appropriate tasks completed by the foster carer and child together. The MIM assesses four dimensions of interaction: Structure, Engagement, Nurture, and Challenge. Interaction recordings will be coded using the Dyadic Emotional Interaction Style (D-EIS), developed in Finland and used internationally.

Sponsors and collaborators

Lead sponsor

Shankland Rebecca

Other

Collaborators

  • Centre Hospitalier Emile Roux
  • Observatoire National de la Protection de l'Enfance (ONPE)

Registry information

Official study title

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

Acronym: SAFE FAMILIES

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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