Maternal Reflective Functioning During the Transition to Motherhood

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Primiparous Women
• Intervention / Treatment: Other: Maternal Reflective Function Workshop

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lee Barel Refaeli, PhD student; Phone Number: 972-504084447; Email: LEEBAREL@GMAIL.COM

Study Locations

• Israel
  • Haifa, Israel, 3103301
    • University of Haifa
    • Contact: Lee Barel Refaeli, PhD student; Phone Number: 972-504084447; Email: LEEBAREL@GMAIL.COM
    • Contact: Barel Refaeli; Phone Number: 0504084447; Email: LEEBAREL@GMAIL.COM
    • Sub-Investigator: Lee Barel Refaeli, PhD student
    • Principal Investigator: Yael Enav, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maternal Reflective Functioning intervention group; Will participate in a 4 session online psycho-educational workshop during pregnancy and after birth, focused on MRF.	Other: 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.
No Intervention: Wiat-list control group; group will undergo same measurements points with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Reflective Functioning questionnaires	Will be measured using Parental Reflective Function questionnaires for pregnancy P-PRFQ (Pajulo et al., 2015) and after birth (Parental Reflective Functioning Questionnaire PRFQ, Luyten et al., 2017). Likert Scale from 1 (Greatly disagree) to 7 (Greatly agree).	Twice in third trimester of pregnancy (Before and after intervention), 1 and 3 months after birth.
Maternal Reflective Functioning interviews	Will be measured using Pregnancy Interview (PI, Slade et al., 1987; Slade, 2003) before labor, and Parental Developmental Interview (PDI-R2 short form, Slade et al., 2003) after labor. Reflective Function Coding Scale- from -1 (No Reflective Function) to 9 (Very high Reflective Function)	Once in third trimester of pregnancy ,1 months after birth.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression.	depression level before, during and after pregnancy and birth, using Edinburgh Postnatal Depression Scale (EPDS, Cox, Holden, & Sagovsky, 1987). Likert Scale from 1 (Most of the time) to 4 (Almost never).	Third trimester of pregnancy, 1 and 3 months after birth.
Anxiety	Anxiety level before, during and after pregnancy and birth using Depression Anxiety Stress Scale (DASS-21 short form, Lovibond & Lovibond, 1995 ). Likert Scale from 0- Does not describe my situation at all, to 3- Describes my situation very much.	Third trimester of pregnancy, 1 and 3 months after birth.
Exposure to traumatic life events	exposure to ongoing war and political violence in the region using Political Life Events (PLE; Based on Slone et al., 1997, elaborated and adjusted by Yael Meir & Yael Enav, 2024, not published). Yes/No question and if Yes answered- Likert Scale from 1- Not at all to 5- Very much.	At enrollment.
Social Support	Social support before and during pregnancy using Multidimensional Scale of Perceived Social Support (MSPSS, Zimet et al., 1988). Likert Scale from 1- Very agree, to 7- Very disagree.	Third trimester of pregnancy, 1 and 3 months after birth.
Relationship satisfaction	Relationship satisfaction before and during pregnancy using Couple satisfaction index (CSI-16, Funk & Rogge, 2007). Likert Scale from 0- Not true at all, to 5- Very true.	Third trimester of pregnancy, 1 and 3 months after birth.
High risk pregnancy	Medical high risk during pregnancy using a single question in initial demographic and personal details questionnaire.	At enrollment.
Cognitive bias	Cognitive bias before, during and after pregnancy and birth using an go-no-go, infants expression interpretation, and focus of attention assignments.	Third trimester of pregnancy, 3 months after birth.
Mother-infant bonding	Mother-infant bonding before birth using Prenatal Attachment Inventory (PAI: Muller & Mercer, 1993) after birth using Postpartum Bonding Questionnaire (PBQ, Brockington et al, 2006 ). PAI Likert Scale from 1- Almost never, to 4- Almost always.	Third trimester of pregnancy, 1 and 3 months after birth.
Mother Emotional Regulation	Measured using Emotional Regulation Questionnaire (ERQ, Gross & John, 2003). Likert Scale from 1- Strongly disagree to 7- Strongly agree. PBQ Likert Scale from 1- Never to 6- Always	Third trimester of pregnancy, 1 and 3 months after birth.
Infant weight	Gain of weight using a single question regarding infant's weight.	1 and 3 months after birth.
Maternal self-efficacy	Measured using Maternal self-efficacy Scale (Kestler-Peleg et al., 2015). Likert Scale from 1- Not at all, to 4- Very much.	1 and 3 months after birth.
Quality of sleep	Quality of sleep using Brief Infant Sleep Questionnaire (BISQ; Sade, 2004). Likert Scale from 1- Not at all to 4- Usually.	1 and 3 months after birth.

Collaborators and Investigators

• Sponsor: University of Haifa
• Investigators: Principal Investigator: Yael Enav, Phd, University of Haifa

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 23, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: depression; anxiety; pregnancy; stress; reflective function; mentalization; primiparous women
• Other Study ID Numbers: 086/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD excluding personal information given by participants in interview (records and transcripts), however coded information for these interview will be shared.
• IPD Sharing Time Frame: Data will be available starting from 1 year after publishing of the primary results, with no limitation on duration of access.
• IPD Sharing Access Criteria: Eligibility*: Access restricted to researchers affiliated with accredited academic institutions or healthcare organizations with relevant credentials.; *Application*: Submit application form, research proposal, and CV to the principal investigator or designated contact.; *Review and Approval*: Applications reviewed by the data access committee. Decision within 4-6 weeks.; *Conditions of Use*: Data to be used solely for the approved project. Maintain confidentiality and data security. No third-party sharing without approval.; *Publication and Reporting*: Submit summary of findings within 12 months. Acknowledge original study in publications and provide copies to the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No