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

March 16, 2026 updated by: Shankland Rebecca

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • France
      • Le Puy-en-Velay, France, France, 43000
        • DEPARTEMENT de la Haute-Loire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Foster carers:

  1. Signed informed consent form.
  2. Commitment to attend all eight sessions of the COS-P program.
  3. Employed by CPS Haute-Loire or by one of the two participating private agencies.

Foster children:

  1. Placed with a foster carer participating in the study.
  2. Aged from 1 to 6 years.
  3. In permanent placement (5 or more days per week with the foster carer).
  4. Consent obtained from all individuals holding parental responsibility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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).
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline and at 3 month f/u
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.
At baseline and at 3-month f/u

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and 3-month f/u
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.
At baseline and 3-month f/u

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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