ParentingNCT04248036
Circle of Security - Parenting, COS-P
A study testing Circle of Security - Parenting, COS-P in people with Parenting and Psychological Phenomena and Processes, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Background: Circle of Security-Parenting is a parental support program that provides basic knowledge about the emotional needs of children up to 6 years old and is illustrated graphically based on a circle model. It is designed to be given in group and includes 8 sessions of 90 minutes each. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parenting, Psychological Phenomena and Processes, Primary Health Care
- What is being tested?
- Circle of Security - Parenting, COS-P
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 30 Jun 2020to 31 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The parent has difficulties in understanding and/or reflecting upon the childs signals/emotional needs.
- The parent has diffuculties in bonding to the child.
- The parent has difficulties in helping the child with emotional regulation.
Who cannot join
- Serious mental illness
- Lack of language skills in Swedish.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Psykologenheten för mödra- och barnhälsovården
Gothenburg, Västra Götaland County
Zekiye Sag, BSc, 0733106567, zekiye.sag@vgregion.se
Zekiye Sag, BSc, 0317479671
About this study
Official title: Trygghetscirkelns föräldraskap (Circle of Security - Parenting) - Gruppintervention för föräldrar Med Barn förskoleåldern - En Pilotstudie.
Background: Circle of Security-Parenting is a parental support program that provides basic knowledge about the emotional needs of children up to 6 years old and is illustrated graphically based on a circle model. It is designed to be given in group and includes 8 sessions of 90 minutes each.
COS-P is regularly offered as a parent support intervention within the Psychology units for Maternal and Child health care in Södra Älvsborg and Fyrbodal with the aim of increasing the quality of the parent-child relationship.
Read more
Objective: Prior to a planned RCT study, clarify which inclusion criterias are used for the COS-P intervention within the two psychology units, which parents accept and complete the study and investigate change in self-assessed depression, anxiety and stress level in the parent, the parent's reflective ability and symptoms in the child estimated by the parent.
Method: The parents who participate in the planned COS-P groups within the two units in spring/autumn of 2020 will fill in surveys before group start, at the end of intervention and 6-months follow up. Change between baseline and posttest as well as between baseline and 6-month follow-up will be analyzed.
The psychologists will fill in specially formulated questionnaires regarding their inclusion criterias.
Expected result: This pilot study is expected to describe the group of parents receiving COS-P and the inclusion criterias for the intervention used by the psychologists in the Psychology units for Maternal and Child health care in Södra Älvsborg and Fyrbodal.
Read the detailed description
Background: Circle of Security-Parenting (COS-P) is a manual-based, psychoeducational parental support program that includes 8 group sessions of 90 minutes each. It provides basic knowledge about the emotional needs of children up to 6 years old and how parents can meet those needs to promote secure attachment in their child.
COS-P is a parental support groupintervention that is regularly given in the Psychology units for Maternal and Child health care in Södra Älvsborg and Fyrbodal and has become an appreciated intervention by both the participants and the psychologists who lead the groups. The method is also increasingly used both in Sweden and internationally but the systematic evaluation of COS-P is at the same time very limited. It is also unclear what the inclusion criterias and outcome measures are for COS-P in the Psychology unit for Maternal and Child health care.
Objective: The purpose of this pilot study is to provide knowledge of the inclusion criterias and outcome measures for COS-P within the Psychological units for Maternal and Child health care in Södra Älvsborg and Fyrbodal before more research subjects and activities are included in a randomized controlled study. The study also aims to examine change in the participating parents between baseline and posttest as well as the 6-month follow-up regarding self-assessed depression, anxiety and stress level, the parent's reflective ability and symptoms in the child estimated by the parent.
Additionally, the study will describe whether there is a relationship between demographic data and self-assessed depression, anxiety, stress level, the parent's reflective ability and symptoms of the child estimated by the parent at baseline and posttest and at baseline and 6-month follow-up.
Method: The parents who are assessed suitable for COS-P and accept to participate in the pilot study during spring/autumn 2020 will fill in surveys before group start, after completion and at the 6-month follow-up. In total, 50 parents will be included in the study.
Psychologists will fill in specially formulated questionnaires regarding their inclusion criterias.
Expected result: This pilot study is expected to describe the group of parents receiving COS-P and the inclusion criterias for the intervention used by the psychologists in the Psychology units for Maternal and Child health care in Södra Älvsborg and Fyrbodal.
- Being tested
- Circle of Security - Parenting, COS-P
- Keywords
- Parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circle of Security - Parenting, COS-PBehavioural
Circle of Security - Parenting is a manual-based, psychoeducational intervention program in group that includes 8 group sessions of 90 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Circle Of Security Parenting, COS-P | Other | Pilot study, assessing eligibility, outcome measures and compliance to Group intervention Receives: Behavioral: Circle of Security - Parenting, COS-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term effect of COS-P on parental reflective functioning.
What is the effect of COS-P on the parent´s capacity to reflect upon both his/her own internal mental experiences and those of the child measured by change in scores in "The Parental Reflective Functioning Questionnaire", the 18 items version, from baseline to posttest?
Measured: Change from baseline to completion of intervention, an average of 8-12 weeks.
Short term effect of parent´s participation in COS-P on the child´s behavioral problems/mental health.
What is the effect of the parent´s participation in COS-P on the child´s behavioral problems/mental health measured by change in scores in "The Strengths and Difficulties Questionnaire (SDQ) for preschool Children" from baseline to posttest..
Measured: Change from baseline to completion of intervention, an average of 8-12 weeks.
Long term effect of COS-P on parental reflective functioning.
What is the effect of COS-P on the parent´s capacity to reflect upon both his/her own internal mental experiences and those of the child measured by change in scores in "The Parental Reflective Functioning Questionnaire", the 18 items version, from baseline to 6-month follow-up?
Measured: Change from baseline to 6-month follow-up.
Long term effect of parent´s participation in COS-P on the child´s behavioral problems/mental health.
What is the effect of the parent´s participation in COS-P on the child´s behavioral problems/mental health measured by change in scores in "The Strengths and Difficulties Questionnaire (SDQ) for preschool Children" from baseline to 6-month follow-up?
Measured: Change from baseline to 6-month follow-up.
Secondary outcomes (6)
Short term effect of COS-P on parental stress level.
What is the effect of COS-P on parental stress level measured by change in scores in "Swedish Parenthood Stress Questionnaire" from baseline to posttest?
Measured: Change from baseline to completion of intervention, an average of 8-12 weeks.
Short term effect of COS-P on depressive mood in parent.
What is the effect of COS-P on depressive mood in parent measured by change in scores in "Beck Depressive Inventory - 2" from baseline to posttest?
Measured: Change from baseline to completion of intervention, an average of 8-12 weeks.
Short term effect of COS-P on anxiety in parent.
What is the effect of COS-P on anxiety in parent measured by change in scores in "Beck Anxiety Inventory" from baseline to posttest?
Measured: Change from baseline to completion of intervention, an average of 8-12 weeks.
Long term effect of COS-P on parental stress level.
What is the effect of COS-P on parental stress level measured by change in scores in "Swedish Parenthood Stress Questionnaire"?
Measured: Change from baseline to 6-month follow-up.
Long term effect of COS-P on depressive mood in parent.
What is the effect of COS-P on depressive mood in parent measured by change in scores in "Beck Depressive Inventory - 2" from baseline to 6-month follow-up?
Measured: Change from baseline to 6-month follow-up.
Long term effect of COS-P on anxiety in parent.
What is the effect of COS-P on anxiety in parent measured by change in scores in "Beck Anxiety Inventory" from baseline to 6-month follow-up?
Measured: Change from baseline to 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start30 Jun 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zekiye Sag, BSc, Principal investigator, Regionhälsan, Region Västra Götaland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248036
- Sponsor's protocol ID
- VGFOUSA-903421
- Status last verified
- Sep 2021
- First submitted
- 19 Jan 2020
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trygghetscirkelns föräldraskap (Circle of Security - Parenting) - Gruppintervention för föräldrar Med Barn förskoleåldern - En Pilotstudie.
- ClinicalTrials.gov ID
- NCT04248036
- Acronym / sponsor ID
- VGFOUSA-903421
- Keywords
- Parenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Jan 2020 (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: Circle of Security-Parenting is a parental support program that provides basic knowledge about the emotional needs of children up to 6 years old and is illustrated graphically based on a circle model. It is designed to be given in group and includes 8 sessions of 90 minutes each.
COS-P is regularly offered as a parent support intervention within the Psychology units for Maternal and Child health care in Södra Älvsborg and Fyrbodal with the aim of increasing the quality of the parent-child relationship.
Objective: Prior to a planned RCT study, clarify which inclusion criterias are used for the COS-P intervention within the two psychology units, which parents accept and complete the study and investigate change in self-assessed depression, anxiety and stress level in the parent, the parent's reflective ability and symptoms in the child estimated by the parent.
Method: The parents who participate in the planned COS-P groups within the two units in spring/autumn of 2020 will fill in surveys before group start, at the end of intervention and 6-months follow up. Change between baseline and posttest as well as between baseline and 6-month follow-up will be analyzed.
The psychologists will fill in specially formulated questionnaires regarding their inclusion criterias.
Expected result: This pilot study is expected to describe the group of parents receiving COS-P and the inclusion criterias for the intervention used by the psychologists in the Psychology units for Maternal and Child health care in Södra Älvsborg and Fyrbodal.
Detailed description
Background: Circle of Security-Parenting (COS-P) is a manual-based, psychoeducational parental support program that includes 8 group sessions of 90 minutes each. It provides basic knowledge about the emotional needs of children up to 6 years old and how parents can meet those needs to promote secure attachment in their child.
COS-P is a parental support groupintervention that is regularly given in the Psychology units for Maternal and Child health care in Södra Älvsborg and Fyrbodal and has become an appreciated intervention by both the participants and the psychologists who lead the groups. The method is also increasingly used both in Sweden and internationally but the systematic evaluation of COS-P is at the same time very limited. It is also unclear what the inclusion criterias and outcome measures are for COS-P in the Psychology unit for Maternal and Child health care.
Objective: The purpose of this pilot study is to provide knowledge of the inclusion criterias and outcome measures for COS-P within the Psychological units for Maternal and Child health care in Södra Älvsborg and Fyrbodal before more research subjects and activities are included in a randomized controlled study. The study also aims to examine change in the participating parents between baseline and posttest as well as the 6-month follow-up regarding self-assessed depression, anxiety and stress level, the parent's reflective ability and symptoms in the child estimated by the parent.
Additionally, the study will describe whether there is a relationship between demographic data and self-assessed depression, anxiety, stress level, the parent's reflective ability and symptoms of the child estimated by the parent at baseline and posttest and at baseline and 6-month follow-up.
Method: The parents who are assessed suitable for COS-P and accept to participate in the pilot study during spring/autumn 2020 will fill in surveys before group start, after completion and at the 6-month follow-up. In total, 50 parents will be included in the study.
Psychologists will fill in specially formulated questionnaires regarding their inclusion criterias.
Expected result: This pilot study is expected to describe the group of parents receiving COS-P and the inclusion criterias for the intervention used by the psychologists in the Psychology units for Maternal and Child health care in Södra Älvsborg and Fyrbodal.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Circle Of Security Parenting, COS-P | Other | Behavioral: Circle of Security - Parenting, COS-PPilot study, assessing eligibility, outcome measures and compliance to Group intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The parent has difficulties in understanding and/or reflecting upon the childs signals/emotional needs.
- The parent has diffuculties in bonding to the child.
- The parent has difficulties in helping the child with emotional regulation.
Key exclusion criteria (2 listed)
- Serious mental illness
- Lack of language skills in Swedish.
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-PCircle of Security - Parenting is a manual-based, psychoeducational intervention program in group that includes 8 group sessions of 90 minutes each. | Behavioural | Circle Of Security Parenting, COS-P |
Primary outcome
Short term effect of COS-P on parental reflective functioning.
Time frame: Change from baseline to completion of intervention, an average of 8-12 weeks.
What is the effect of COS-P on the parent´s capacity to reflect upon both his/her own internal mental experiences and those of the child measured by change in scores in "The Parental Reflective Functioning Questionnaire", the 18 items version, from baseline to posttest?
Short term effect of parent´s participation in COS-P on the child´s behavioral problems/mental health.
Time frame: Change from baseline to completion of intervention, an average of 8-12 weeks.
What is the effect of the parent´s participation in COS-P on the child´s behavioral problems/mental health measured by change in scores in "The Strengths and Difficulties Questionnaire (SDQ) for preschool Children" from baseline to posttest..
Long term effect of COS-P on parental reflective functioning.
Time frame: Change from baseline to 6-month follow-up.
What is the effect of COS-P on the parent´s capacity to reflect upon both his/her own internal mental experiences and those of the child measured by change in scores in "The Parental Reflective Functioning Questionnaire", the 18 items version, from baseline to 6-month follow-up?
Long term effect of parent´s participation in COS-P on the child´s behavioral problems/mental health.
Time frame: Change from baseline to 6-month follow-up.
What is the effect of the parent´s participation in COS-P on the child´s behavioral problems/mental health measured by change in scores in "The Strengths and Difficulties Questionnaire (SDQ) for preschool Children" from baseline to 6-month follow-up?
6 secondary outcomes
Short term effect of COS-P on parental stress level.
Time frame: Change from baseline to completion of intervention, an average of 8-12 weeks.
Short term effect of COS-P on depressive mood in parent.
Time frame: Change from baseline to completion of intervention, an average of 8-12 weeks.
Short term effect of COS-P on anxiety in parent.
Time frame: Change from baseline to completion of intervention, an average of 8-12 weeks.
Long term effect of COS-P on parental stress level.
Time frame: Change from baseline to 6-month follow-up.
Long term effect of COS-P on depressive mood in parent.
Time frame: Change from baseline to 6-month follow-up.
Long term effect of COS-P on anxiety in parent.
Time frame: Change from baseline to 6-month follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
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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.
Zekiye Sag, BSc principal investigator
Regionhälsan, Region Västra Götaland
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 in people with Parenting and Psychological Phenomena and Processes, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Nov 2021. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zekiye Sag, BSc (+46(0)317479671, zekiye.sag@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term effect of COS-P on parental reflective functioning. (time frame: Change from baseline to completion of intervention, an average of 8-12 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2021.