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Not yet recruiting NCT06476626

Maternal Reflective Functioning During the Transition to Motherhood

No phase Interventional Pregnancy Primiparous Women

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Maternal Reflective Function Workshop.
Who it may be relevant to
Registry conditions: Pregnancy, Primiparous Women. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

  • 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.

Primary outcome measures

  • Maternal Reflective Functioning questionnaires [Time frame: Twice in third trimester of pregnancy (Before and after intervention), 1 and 3 months after birth.]
  • Maternal Reflective Functioning interviews [Time frame: Once in third trimester of pregnancy ,1 months after birth.]
Secondary outcome measures (12)
  • Depression. [Time frame: Third trimester of pregnancy, 1 and 3 months after birth.]
  • Anxiety [Time frame: Third trimester of pregnancy, 1 and 3 months after birth.]
  • Exposure to traumatic life events [Time frame: At enrollment.]
  • Social Support [Time frame: Third trimester of pregnancy, 1 and 3 months after birth.]
  • Relationship satisfaction [Time frame: Third trimester of pregnancy, 1 and 3 months after birth.]
  • High risk pregnancy [Time frame: At enrollment.]
  • Cognitive bias [Time frame: Third trimester of pregnancy, 3 months after birth.]
  • Mother-infant bonding [Time frame: Third trimester of pregnancy, 1 and 3 months after birth.]
  • Mother Emotional Regulation [Time frame: Third trimester of pregnancy, 1 and 3 months after birth.]
  • Infant weight [Time frame: 1 and 3 months after birth.]
  • Maternal self-efficacy [Time frame: 1 and 3 months after birth.]
  • Quality of sleep [Time frame: 1 and 3 months after birth.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Israel · 1 center
  • University of Haifa — Haifa

Identifiers

NCT: NCT06476626 · 086/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗