About this trial
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:
1. 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. 2. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of PCOS
Obesity according to BMI
Gave birth at Oulu University Hospital in 2024-25
PEPPI cohort study participation
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
ECoFam
BehavioralMother-infant dyads randomized into the intervention group receive four personal coaching sessions to facilitate emotional connection via multisensory channels including comfort touch and communication of face-to-face affect during holding time.
Treatment groups
Trial outcomes
Primary outcomes
Universal Welch Emotional Connection Screen (uWECS)
Emotional connection evaluated with the uWECS
Secondary outcomes
Mothers' mental health problems
Mothers' mental health problems are assessed with a range of standardized questionnaires using RedCap; higher scores mean worse outcomes.
Sponsors and contacts
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Oulu University Hospital
Lead sponsor
University of Oulu
Collaborator