Parenting SensitivitySAFE FAMILIESNCT06701877
Enhancing Foster Care Relationships Through Attachment-Based Intervention: Protocol of SAFE FAMILY STUDY
A study testing Circle of security Parenting (COS-P) and Traitement as usual (TAU) in people with Parenting Sensitivity and Foster Care, run by Shankland Rebecca at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parenting Sensitivity, Foster Care
- What is being tested?
- Circle of security Parenting (COS-P) and Traitement as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Parenting Sensitivity, Foster Care
- Being tested
- Circle of security Parenting (COS-P), Traitement as usual (TAU)
- Keywords
- foster care, Attachment, Circle of Security Parenting intervention, resilience, intervention evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circle of security Parenting (COS-P)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Traitement as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline and at 3-month f/u
Secondary outcomes (2)
Parenting Stress Index - IV - Short Form (PSI)
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.
Measured: At baseline and 3-month f/u
Marschak Interaction Method (MIM)
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.
Measured: At baseline and 3-month f/u
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start10 Oct 2024
- Primary completion1 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parenting SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shankland Rebecca
- Sponsor type
- University, hospital or other
- Collaborators
- Observatoire National de la Protection de l'Enfance (ONPE), Centre Hospitalier Emile Roux
- Responsible party
- Sponsor-investigator, Shankland Rebecca, Université Lumière Lyon 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701877
- Sponsor's protocol ID
- SAFE FAMILIES (ULL2/ONPE)
- Acronym
- SAFE FAMILIES
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34816157Helle 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.
PubMed 36314235Engler 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.
PubMed 32686611Pereira 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.
PubMed 39923102
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06701877
- Acronym / sponsor ID
- SAFE FAMILIES / SAFE FAMILIES (ULL2/ONPE)
- Conditions
- Parenting Sensitivity, Foster Care
- Keywords
- foster care, Attachment, Circle of Security Parenting intervention, resilience, intervention evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shankland RebeccaUniversity, hospital or other
- Collaborators
- Observatoire National de la Protection de l'Enfance (ONPE), Centre Hospitalier Emile Roux
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Traitement as usual (TAU)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Placed with a foster carer participating in the study.
- Aged from 1 to 6 years.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circle of security Parenting (COS-P)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). | Behavioural | – |
| Traitement as usual (TAU)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. | Behavioural | Waitlist control group |
Primary outcome
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.
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.
2 secondary outcomes
Parenting Stress Index - IV - Short Form (PSI)
Time frame: At baseline and 3-month f/u
Marschak Interaction Method (MIM)
Time frame: At baseline and 3-month f/u
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 34816157Maxwell 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.
- Background: PubMed 36314235Helle 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.
- Background: PubMed 32686611Engler 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.
- Derived from this study: PubMed 39923102Pereira 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circle of security Parenting (COS-P) and Traitement as usual (TAU) in people with Parenting Sensitivity and Foster Care, run by Shankland Rebecca at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiving composite questionnaire (CCQ) (time frame: at baseline and at 3 month f/u). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06701877, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.