Clinical trial NCT06701877: Enhancing Foster Care Relationships Through Attachment-Based Intervention: Protocol of SAFE FAMILY STUDY
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parenting Sensitivity
Foster Care
Keywords: foster care, Attachment, Circle of Security Parenting intervention, resilience, intervention evaluation
Lead sponsor: Université Lumière Lyon 2
Sponsor class: OTHER
Collaborators: name: Observatoire National de la Protection de l'Enfance (ONPE)
name: Centre Hospitalier Emile Roux
First posted: 2024-11-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Caregiving composite questionnaire (CCQ)
timeFrame: at baseline and at 3 month f/u
measure: Parent Development Interview-Revised
timeFrame: At baseline and at 3-month f/u
Secondary outcomes:
measure: Parenting Stress Index - IV - Short Form (PSI)
timeFrame: At baseline and 3-month f/u
measure: Marschak Interaction Method (MIM)
timeFrame: At baseline and 3-month f/u
Other outcomes:
Locations:
city: Le Puy-en-Velay
country: France
facility: DEPARTEMENT de la Haute-Loire
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.