Clinical trial NCT04248036: Circle of Security - Parenting, COS-P
Official title: Trygghetscirkelns föräldraskap (Circle of Security - Parenting) - Gruppintervention för föräldrar Med Barn förskoleåldern - En Pilotstudie.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parenting
Psychological Phenomena and Processes
Primary Health Care
Keywords: Parenting
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2020-01-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* Serious mental illness
* Lack of language skills in Swedish.

Primary outcomes:
measure: Short term effect of COS-P on parental reflective functioning.
timeFrame: Change from baseline to completion of intervention, an average of 8-12 weeks.
measure: Short term effect of parent´s participation in COS-P on the child´s behavioral problems/mental health.
timeFrame: Change from baseline to completion of intervention, an average of 8-12 weeks.
measure: Long term effect of COS-P on parental reflective functioning.
timeFrame: Change from baseline to 6-month follow-up.
measure: Long term effect of parent´s participation in COS-P on the child´s behavioral problems/mental health.
timeFrame: Change from baseline to 6-month follow-up.
Secondary outcomes:
measure: Short term effect of COS-P on parental stress level.
timeFrame: Change from baseline to completion of intervention, an average of 8-12 weeks.
measure: Short term effect of COS-P on depressive mood in parent.
timeFrame: Change from baseline to completion of intervention, an average of 8-12 weeks.
measure: Short term effect of COS-P on anxiety in parent.
timeFrame: Change from baseline to completion of intervention, an average of 8-12 weeks.
measure: Long term effect of COS-P on parental stress level.
timeFrame: Change from baseline to 6-month follow-up.
measure: Long term effect of COS-P on depressive mood in parent.
timeFrame: Change from baseline to 6-month follow-up.
measure: Long term effect of COS-P on anxiety in parent.
timeFrame: Change from baseline to 6-month follow-up.
Other outcomes:
measure: A questionnaire designed for the psychologists in the study containing 4 specific questions.
timeFrame: Through study completion, an average of 1 year.
Locations:
city: Göteborg
country: Sweden
facility: Psykologenheten för mödra- och barnhälsovården
state: Västra Götaland
Study officials:
affiliation: Regionhälsan, Region Västra Götaland
name: Zekiye Sag, BSc
role: PRINCIPAL_INVESTIGATOR
References: