Pregnancy, Primiparous Women
Conditions
Keywords
pregnancy, primiparous women, anxiety, depression, stress, mentalization, reflective function
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.
Interventions
OTHERMaternal 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.
Sponsors
University of Haifa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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 |
| Infant weight | 1 and 3 months after birth. | Gain of weight using a single question regarding infant's weight. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Israel
Contacts
Primary ContactLee Barel Refaeli, PhD student
Outcome results
None listed