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| Name | Class |
|---|---|
| University of Oulu | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECoFam intervention | Experimental | personalized coaching sessions |
|
| treatment-as-usual (TAU) | No Intervention | control group, no intervention administered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Universal Welch Emotional Connection Screen (uWECS) | Emotional connection evaluated with the uWECS | From enrollment to the end of intervention and follow-up at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mothers' mental health problems | Mothers' mental health problems are assessed with a range of standardized questionnaires using RedCap; higher scores mean worse outcomes. | From enrollment to end of intervention and follow-up 4 months |
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Inclusion Criteria:
Exclusion Criteria:
- Infant death
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia Jaekel, PhD | Contact | 358458043150 | apfelliebhaber@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Julia Jäkel, Dr. phil. habil. | University of Oulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Recruiting | Oulu | Finland |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |