NCT06701877

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

November 19, 2024

Last Update Submit

March 16, 2026

Conditions

Keywords

foster care, Attachment, Circle of Security Parenting intervention, resilience, intervention evaluation

Outcome Measures

Primary Outcomes (2)

  • Caregiving composite questionnaire (CCQ)

    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

    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 Outcomes (2)

  • 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

Study Arms (2)

COSP Intervention Group

EXPERIMENTAL

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

ACTIVE COMPARATOR

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.

Behavioral: Traitement as usual (TAU)

Interventions

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.

Waitlist control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DEPARTEMENT de la Haute-Loire

Le Puy-en-Velay, France, 43000, France

Location

Related Publications (4)

  • Maxwell AM, McMahon C, Huber A, Hawkins E, Reay RE. Addressing the Evidence Gap: Protocol for an Effectiveness Study of Circle of Security Parenting, an Attachment-Based Intervention. Front Glob Womens Health. 2020 Oct 22;1:575752. doi: 10.3389/fgwh.2020.575752. eCollection 2020.

    PMID: 34816157BACKGROUND
  • Helle J, Vollestad J, Schanche E, Hjelen Stige S. From seeing difficult behaviour to recognizing legitimate needs - A qualitative study of mothers' experiences of participating in a Circle of Security Parenting program in a public mental health setting. Psychother Res. 2023 Apr;33(4):482-493. doi: 10.1080/10503307.2022.2132888. Epub 2022 Oct 31.

    PMID: 36314235BACKGROUND
  • Engler AD, Sarpong KO, Van Horne BS, Greeley CS, Keefe RJ. A Systematic Review of Mental Health Disorders of Children in Foster Care. Trauma Violence Abuse. 2022 Jan;23(1):255-264. doi: 10.1177/1524838020941197. Epub 2020 Jul 20.

    PMID: 32686611BACKGROUND
  • Pereira M, Sedes L, Gadea E, Shankland R. Enhancing foster care relationships through attachment-based intervention: the safe families study protocol, a randomized controlled trial of the circle of security parenting program(R). BMC Psychol. 2025 Feb 8;13(1):107. doi: 10.1186/s40359-025-02424-6.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Full Professor of health and developmental psychology

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 22, 2024

Study Start

October 10, 2024

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations