Maternal Reflective Functioning During the Transition to Motherhood

NCT ID: NCT06476626

Last Updated: 2024-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2027-08-30

Brief Summary

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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

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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.

Conditions

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Pregnancy Primiparous Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Maternal Reflective Functioning intervention group

Will participate in a 4 session online psycho-educational workshop during pregnancy and after birth, focused on MRF.

Group Type EXPERIMENTAL

Maternal Reflective Function Workshop

Intervention Type OTHER

4 session group online intervention focused on psycho-educational knowledge regarding emotional regulation and specifically MRF. group size- up to 15 participants. 2 sessions will be during pregnancy and 2 sessions will taken place 1 and 3 months after birth.

Wiat-list control group

group will undergo same measurements points with no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Maternal Reflective Function Workshop

4 session group online intervention focused on psycho-educational knowledge regarding emotional regulation and specifically MRF. group size- up to 15 participants. 2 sessions will be during pregnancy and 2 sessions will taken place 1 and 3 months after birth.

Intervention Type OTHER

Eligibility Criteria

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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\'t participate in a online workshop due to physical or mental health difficulties.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Haifa

OTHER

Sponsor Role lead

Responsible Party

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Yael Enav

Head of Emotional Regulation and Mentalization Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yael Enav, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Haifa

Locations

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University of Haifa

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Lee Barel Refaeli, PhD student

Role: CONTACT

972-504084447

Facility Contacts

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Lee Barel Refaeli, PhD student

Role: primary

972-504084447

Barel Refaeli

Role: backup

0504084447

Other Identifiers

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086/24

Identifier Type: -

Identifier Source: org_study_id

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