Circle of Security - Parenting, COS-P

NCT04248036 | Unknown

• 1 other identifier: VGFOUSA-903421
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting; Psychological Phenomena and Processes; Primary Health Care

Keywords

Parenting

Outcome Measures

Primary Outcomes (4)

• 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?

  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..

  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?

  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?

  Change from baseline to 6-month follow-up.

Secondary Outcomes (6)

• Short term effect of COS-P on parental stress level.

  Change from baseline to completion of intervention, an average of 8-12 weeks.

• Short term effect of COS-P on depressive mood in parent.

  Change from baseline to completion of intervention, an average of 8-12 weeks.

• Short term effect of COS-P on anxiety in parent.

  Change from baseline to completion of intervention, an average of 8-12 weeks.

• Long term effect of COS-P on parental stress level.

  Change from baseline to 6-month follow-up.

• Long term effect of COS-P on depressive mood in parent.

  Change from baseline to 6-month follow-up.

Other Outcomes (1)

• A questionnaire designed for the psychologists in the study containing 4 specific questions.

  Through study completion, an average of 1 year.

Study Arms (1)

Circle Of Security Parenting, COS-P

OTHER

Pilot study, assessing eligibility, outcome measures and compliance to Group intervention

Behavioral: Circle of Security - Parenting, COS-P

Interventions

Circle of Security - Parenting, COS-P BEHAVIORAL

Circle of Security - Parenting is a manual-based, psychoeducational intervention program in group that includes 8 group sessions of 90 minutes each.

Circle Of Security Parenting, COS-P

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Psykologenheten för mödra- och barnhälsovården

Gothenburg, Västra Götaland County, Sweden

RECRUITING

Study Officials

• Zekiye Sag, BSc

  Regionhälsan, Region Västra Götaland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zekiye Sag, BSc

CONTACT

+46(0)317479671; zekiye.sag@vgregion.se

Lena Nordeman, PhD

CONTACT

+46(0)701714463; lena.nordeman@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Group Care providers are masked for outcome assesment
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 30, 2020
• Study Start: June 30, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 15, 2021

Record last verified: 2021-09

Locations

SE (1)