Center for Clinical Research and Prevention, Frederiksberg Hospital, Nordre Fasanvej 57, Vej 8, Indgang 1, 1.sal, 2000, Frederiksberg, Denmark.
Centre for Early Intervention and Family Studies, Department of Psychology, University of Copenhagen, Copenhagen, Denmark.
BMC Psychol. 2020 Apr 28;8(1):41. doi: 10.1186/s40359-020-00407-3.
Maternal mental well-being and social circumstances during pregnancy and early childhood impact the child's well-being and development. Supportive and sensitive parenting is one of the strongest predictors of positive emotional, social and behavioral outcomes for the child. Knowledge is needed about how to detect and support vulnerable families already during pregnancy and in the postnatal period. The aim of this study is to assemble and evaluate an interdisciplinary cross-sectoral intervention to promote maternal sensitivity among women with psychological or social vulnerabilities.
METHODS/DESIGN: This randomized controlled trial tests the efficacy of an intervention program in the perinatal period compared to care as usual in enhancing maternal sensitivity in a group of psychologically or socially vulnerable women in the Capital Region of Denmark. The intervention consists of four components: 1) detecting symptoms of mental illness in vulnerable pregnant women and initiating treatment if indicated, 2) strengthening parenting skills using the Circle of Security Parenting program, 3) supporting breastfeeding, and 4) sharing knowledge and organizing treatment pathways for families across sectors. Seventy-six families will be randomly assigned to the intervention or care-as-usual. Data will be obtained at study inclusion at 3-5 months of pregnancy, eight weeks after childbirth, and nine months after childbirth. The primary outcome is maternal sensitivity. Secondary outcomes include infant's socio-emotional development, parents' mentalization, parental stress, depressive symptoms, and parental wellbeing. Qualitative data will provide insight into the implementation process.
This paper presents the rational and background for developing the intervention. Furthermore, the design and protocol of the randomized controlled trial. It is hypothesized that the intervention will be associated with positive changes in primary and secondary outcomes. If effective, the intervention will provide insights into prenatal risk profiles among an identified group of psychosocial vulnerable women important for early screening and point to effective preventive interventions that can support women in the perinatal period, increase maternal sensitivity and promote positive child development -starting before the child is born.
ClinicalTrials.gov: ID: NCT03190707. Registered June 16, 2017.
孕妇和幼儿期的产妇心理健康和社会环境会影响孩子的健康和发育。支持和敏感的育儿方式是孩子获得积极的情感、社交和行为结果的最强预测因素之一。我们需要了解如何在怀孕期间和产后阶段发现和支持脆弱家庭。本研究的目的是收集和评估跨学科跨部门干预措施，以提高有心理或社会脆弱性的女性的母性敏感性。
方法/设计：本随机对照试验测试了在丹麦首都地区，与常规护理相比，在围产期实施干预方案对一组心理或社会脆弱孕妇提高母性敏感性的效果。该干预措施包括四个部分：1）检测脆弱孕妇的精神疾病症状并在需要时开始治疗，2）使用安全圈育儿计划增强育儿技能，3）支持母乳喂养，4）跨部门分享知识并组织家庭治疗途径。76 个家庭将被随机分配到干预组或常规护理组。数据将在妊娠 3-5 个月、产后 8 周和产后 9 个月时进行收集。主要结局是母性敏感性。次要结局包括婴儿的社会情感发展、父母的心理化、父母的压力、抑郁症状和父母的幸福感。定性数据将提供对实施过程的深入了解。
本文介绍了干预措施的制定的理由和背景。此外，还介绍了随机对照试验的设计和方案。研究假设干预将与主要和次要结局的积极变化相关。如果有效，该干预措施将为特定的心理社会脆弱女性群体的产前风险概况提供见解，这对早期筛查很重要，并指出有效的预防干预措施，这些措施可以在围产期为女性提供支持，提高母性敏感性，促进儿童积极发展-甚至在孩子出生前就开始。
ClinicalTrials.gov：ID：NCT03190707。注册于 2017 年 6 月 16 日。
