Pregnancy Without Psychosocial Stress
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|ClinicalTrials.gov Identifier: NCT04853693|
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
The project is aimed at children who are exposed to the toxic psychosocial stress present in their mothers during pregnancy or after childbirth. Due to psychosocial stress in their mothers, these children are at risk of developing a mental disorder or having impaired psychosocial development.
In Czechia, there is no prevention of psychosocial stress in women, which also plays a preventive role in the development of mental disorders in their children. Mental disorders in parents are stigmatized in Czechia, which prevents parents from seeking care.
The investigators want to change this situation, so they will:
- create and pilot a screening program for psychosocial stress in perinatal women in gynecological clinics
- connect the screening program to the integrated step care system created by the investigators, including peer support, which the investigators will test
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms Anxiety Disorders and Symptoms Depression, Postpartum||Behavioral: Mom´s Supporting Mom Behavioral: Enhanced Treatment As Usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two groups: One receives MSM prevention intervention and the other group receives Enhanced Treatment as Usual (referral and monitoring).|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The investigator and person administering the outcome measures are blind to participant group|
|Official Title:||Pregnancy Without Psychosocial Stress - the Earliest Prevention of Mental Disorders and Toxic Stress in Children|
|Actual Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||March 31, 2023|
Experimental: Mom´s Supporting Mom (MSM)
A preventive intervention that involves psychoeducation and peer techniques described in study detailed description.
Behavioral: Mom´s Supporting Mom
A preventive peer consultation intervention for Postpartum Depression.
Other Name: MSM
Active Comparator: Enhanced Treatment as Usual
Referral to treatment in the community and monitoring
Behavioral: Enhanced Treatment As Usual
Referral to treatment in the community, clinical monitoring
Other Name: ETAU
- Treatment gap for postpartum mental disorders [ Time Frame: 6 weeks postpartum ]prevalence of untreated mental health disorders in postpartum women assessed by The Mini-International Neuropsychiatric Interview
- Pregnancy depressive symptoms [ Time Frame: up to 32 weeks ]self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
- Postpartum depressive symptoms [ Time Frame: 6 weeks postpartum ]self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
- Pregnancy anxiety symptoms [ Time Frame: up to 32 weeks ]self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.
- Postpartum anxiety symptoms [ Time Frame: 6 weeks postpartum ]self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.
- Psychosocial stress factors [ Time Frame: through study completion, an average of 1 year ]self-rated psychosocial stress factors measured by Prenatal psychosocial profile. Score range 11 - 44, higher score represents worse outcome.
- Prenatal mother-baby attachment [ Time Frame: up to 32 weeks ]self-report measure of maternal-fetal attachment measured by Prenatal Attachment Inventory
- Parenting competences [ Time Frame: 6 weeks postpartum ]self-report measure od maternal sense of parenting competence measured by Parenting Sense of Competence Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853693
|Contact: Pavla Spadova, Ph.D.||+420 283 088 111||Pavla.Spadova@nudz.cz|
|National Institute of Mental Health||Recruiting|
|Klecany, Czechia, 25067|
|Contact: Pavla Spadova +420 283 088 436 Pavla.Spadova@nudz.cz|
|Principal Investigator:||Antonin Sebela, Ph.D.||National Institute of Mental Health, Klecany, Czechia|