Maternal Reflective Functioning During the Transition to Motherhood

Not Applicable

Not yet recruiting

• Conditions: Pregnancy; Primiparous Women

• Registration Number: NCT06476626
• Lead Sponsor: University of Haifa

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.

Study Timeline

• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-23
• Study First Posted: 2024-06-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Study Start: 2024-07-15
• Primary Completion: 2026-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal Reflective Functioning questionnaires	Twice in third trimester of pregnancy (Before and after intervention), 1 and 3 months after birth.	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).
Maternal Reflective Functioning interviews	Once in third trimester of pregnancy ,1 months after birth.	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)

Secondary Outcome Measures

Name	Time	Method
Anxiety	Third trimester of pregnancy, 1 and 3 months after birth.	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.
Social Support	Third trimester of pregnancy, 1 and 3 months after birth.	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.
Infant weight	1 and 3 months after birth.	Gain of weight using a single question regarding infant's weight.
Depression.	Third trimester of pregnancy, 1 and 3 months after birth.	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).
High risk pregnancy	At enrollment.	Medical high risk during pregnancy using a single question in initial demographic and personal details questionnaire.
Cognitive bias	Third trimester of pregnancy, 3 months after birth.	Cognitive bias before, during and after pregnancy and birth using an go-no-go, infants expression interpretation, and focus of attention assignments.
Mother Emotional Regulation	Third trimester of pregnancy, 1 and 3 months after birth.	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
Exposure to traumatic life events	At enrollment.	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.
Relationship satisfaction	Third trimester of pregnancy, 1 and 3 months after birth.	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.
Mother-infant bonding	Third trimester of pregnancy, 1 and 3 months after birth.	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.
Quality of sleep	1 and 3 months after birth.	Quality of sleep using Brief Infant Sleep Questionnaire (BISQ; Sade, 2004). Likert Scale from 1- Not at all to 4- Usually.
Maternal self-efficacy	1 and 3 months after birth.	Measured using Maternal self-efficacy Scale (Kestler-Peleg et al., 2015). Likert Scale from 1- Not at all, to 4- Very much.

Trial Locations

Locations (1)

University of Haifa; 🇮🇱 Haifa, Israel