跳至主要内容
临床试验/NCT04248036
NCT04248036Unknown不适用

Trygghetscirkelns föräldraskap (Circle of Security - Parenting) - Gruppintervention för föräldrar Med Barn förskoleåldern - En Pilotstudie.

Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Long term effect of parent´s participation in COS-P on the child´s behavioral problems/mental health.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

Group Care providers are masked for outcome assesment

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Long term effect of parent´s participation in COS-P on the child´s behavioral problems/mental health.

时间窗: 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?

Long term effect of COS-P on parental reflective functioning.

时间窗: 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?

Short term effect of COS-P on parental reflective functioning.

时间窗: 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.

时间窗: 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..

次要结局

  • 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 depressive mood in parent.(Change from baseline to 6-month follow-up.)
  • Long term effect of COS-P on anxiety in parent.(Change from baseline to 6-month follow-up.)
  • Long term effect of COS-P on parental stress level.(Change from baseline to 6-month follow-up.)
  • 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.)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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