Maternal Reflective Functioning During the Transition to Motherhood
NCT Number: NCT06476626
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy|Primiparous Women
Interventions: OTHER: Maternal Reflective Function Workshop
Sponsor: University of Haifa
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-15
Completion Date: 2027-08-30
Locations: University of Haifa, Haifa, 3103301, Israel

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.

Primary Outcome Measures: 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: 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.