Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Universal Welch Emotional Connection Screen (uWECS)
研究概览
简要总结
It is both timely and important to invest in interventions that can improve healthy emotional co-regulation. It is proposed to evaluate the feasibility and limited efficacy of an adapted, brief, multimodal intervention: ECoFam (Emotional connection and Co-regulation for Families). Evidence from the US suggests intervention effects on maternal and infant outcomes that are large in effect size (i.e., Cohen's d >0.6 for increasing emotional connection and decreasing maternal depressive symptoms) (21-23). The study results will directly translate evidence into practice and, if found feasible, allow rapid scaling-up.
Objectives:
- Build capacity for implementation of a novel diagnostic screening tool for emotional co-regulation, the uWECS, as part of clinical follow-up for mother-infant dyads with high fibrobesity risk in Finland.
- Test the feasibility and limited efficacy of the brief, multimodal ECoFam intervention to foster healthy emotional co-regulation between mothers with PCOS and obesity and their infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PCOS
- •Obesity according to BMI
- •Gave birth at Oulu University Hospital in 2024-25
- •PEPPI cohort study participation
- •uWECS emotional connection score <9.0 at pre-test
排除标准
- •Infant death
结局指标
主要结局
Universal Welch Emotional Connection Screen (uWECS)
时间窗: From enrollment to the end of intervention and follow-up at 4 months
Emotional connection evaluated with the uWECS
次要结局
- Mothers' mental health problems(From enrollment to end of intervention and follow-up 4 months)
研究者
Julia Jaekel
Prof. Dr.
Oulu University Hospital