Clinical trial NCT06476626: Maternal Reflective Functioning During the Transition to Motherhood
Official title: Maternal Reflective Functioning During the Transition to Motherhood as a Protective Factor in the Relationship Between Personal and Environmental Characteristics and the Mental Health of Both the Mother and the Infant
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Primiparous Women
Keywords: pregnancy
primiparous women
anxiety
depression
stress
mentalization
reflective function
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn about Maternal Reflective Function (MRF) during the transition to motherhood. The main questions it aims to answer are:

Does MRF mediates the connection between risk factors for mental health difficulties during first pregnancy and motherhood (the transition to motherhood) and outcomes related to the mother, the infant, and their relationship.

Participants will:

Answer questionnaires and clinical interviews during pregnancy and after birth of the first child (twice at third trimester, 1 and 3 months after birth).

intervention group will participate in an online short intervention to enhance MRF.

Detailed description: Using this trial, the investigators will be able to better understand rather MRF moderate the connection between risk factors to outcomes after birth related to both the mother and the infant. Using RCT design we will be able to understand mechanism of change.

Eligibility criteria: Inclusion Criteria:

* pregnant women in 27-30 weeks pregnant in enrollment
* speak read and understand Hebrew
* Has a connection to internet and ZOOM platform.
* Ready to participate in a group workshop

Exclusion Criteria:

* Women who can\&#39;t participate in a online workshop due to physical or mental health difficulties.

Primary outcomes:
measure: Maternal Reflective Functioning questionnaires
timeFrame: Twice in third trimester of pregnancy (Before and after intervention), 1 and 3 months after birth.
measure: Maternal Reflective Functioning interviews
timeFrame: Once in third trimester of pregnancy ,1 months after birth.
Secondary outcomes:
measure: Depression.
timeFrame: Third trimester of pregnancy, 1 and 3 months after birth.
measure: Anxiety
timeFrame: Third trimester of pregnancy, 1 and 3 months after birth.
measure: Exposure to traumatic life events
timeFrame: At enrollment.
measure: Social Support
timeFrame: Third trimester of pregnancy, 1 and 3 months after birth.
measure: Relationship satisfaction
timeFrame: Third trimester of pregnancy, 1 and 3 months after birth.
measure: High risk pregnancy
timeFrame: At enrollment.
measure: Cognitive bias
timeFrame: Third trimester of pregnancy, 3 months after birth.
measure: Mother-infant bonding
timeFrame: Third trimester of pregnancy, 1 and 3 months after birth.
measure: Mother Emotional Regulation
timeFrame: Third trimester of pregnancy, 1 and 3 months after birth.
measure: Infant weight
timeFrame: 1 and 3 months after birth.
measure: Maternal self-efficacy
timeFrame: 1 and 3 months after birth.
measure: Quality of sleep
timeFrame: 1 and 3 months after birth.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
affiliation: University of Haifa
name: Yael Enav, Phd
role: PRINCIPAL_INVESTIGATOR
References: