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NCT Number: NCT06476626

Maternal Reflective Functioning During the Transition to Motherhood

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.

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Key information

Conditions

Pregnancy Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Primiparous Women

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maternal Reflective Function Workshop

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.

Primary outcomes

  1. Maternal Reflective Functioning questionnaires

    Time frame: 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).

  2. Maternal Reflective Functioning interviews

    Time frame: 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 outcomes

  1. Depression.

    Time frame: 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).

  2. Anxiety

    Time frame: 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.

  3. Exposure to traumatic life events

    Time frame: 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.

  4. Social Support

    Time frame: 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.

  5. Relationship satisfaction

    Time frame: 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.

  6. High risk pregnancy

    Time frame: At enrollment.

    Medical high risk during pregnancy using a single question in initial demographic and personal details questionnaire.

  7. Cognitive bias

    Time frame: 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.

  8. Mother-infant bonding

    Time frame: 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.

  9. Mother Emotional Regulation

    Time frame: 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

  10. Infant weight

    Time frame: 1 and 3 months after birth.

    Gain of weight using a single question regarding infant's weight.

  11. Maternal self-efficacy

    Time frame: 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.

  12. Quality of sleep

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lee Barel Refaeli, PhD student

CONTACT

[email protected]

972-504084447

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 26, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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