Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorOulu University Hospital

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 volunteers

Qualifiers

Diagnosis of PCOS

Obesity according to BMI

Gave birth at Oulu University Hospital in 2024-25

PEPPI cohort study participation

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • ECoFam

    Behavioral

    Mother-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

40 Participants
are divided into 2 treatment groups
Group A: ECoFam interventionExperimental treatment 1 intervention
Group B: treatment-as-usual (TAU)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Universal Welch Emotional Connection Screen (uWECS)

Emotional connection evaluated with the uWECS

Time frame
From enrollment to the end of intervention and follow-up at 4 months

Secondary outcomes

1

Mothers' mental health problems

Mothers' mental health problems are assessed with a range of standardized questionnaires using RedCap; higher scores mean worse outcomes.

Time frame
From enrollment to end of intervention and follow-up 4 months

Other outcomes

Sponsors and contacts

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Oulu University Hospital

Lead sponsor

University of Oulu

Collaborator