Brief Psycho-educational Intervention to Enhance Maternal Reflective Functioning in the Early Postpartum Among Primiparous: Pilot Study

December 24, 2025 updated by: Lee Barel Refaeli, University of Haifa

Randomized Controlled Pilot Trial of a Brief Psycho-educational Intervention to Enhance Maternal Reflective Functioning in the Early Postpartum Among First-Time Mothers

This randomized pilot trial tests a brief psycho-educational group program designed to enhance maternal reflective functioning (RF)-the capacity to understand one's own and the baby's behavior in terms of thoughts and feelings-among first-time mothers in the early postpartum. Primiparous women aged ≥18 years, 1-5 months postpartum, were randomized 1:1 to the intervention or a wait-list control. The intervention consists of four weekly 90-minute Zoom sessions with short home practices.

The primary outcome is interview-based RF assessed with the FMSS-RF (blind-coded) at post-intervention. Exploratory outcomes include self-reported RF (PRFQ-CMS), depressive symptoms (EPDS), emotion-regulation (ERQ-Suppression), and feasibility/acceptability indices (recruitment, retention, attendance, satisfaction).

This single-site study is conducted at the University of Haifa (Faculty of Education). If effective, the low-intensity, telehealth format may offer a scalable postpartum support option for first-time mothers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale. The transition to first-time motherhood is a sensitive period for women's mental health and for establishing early caregiving. Maternal reflective functioning (RF) supports sensitive caregiving and mother-infant adaptation, yet brief and scalable RF-focused postpartum supports are scarce. We developed a short psycho-educational program targeting core RF skills (identifying mental states, pausing and reflecting under stress, reading infant cues, perspective-taking, and repairing mismatches).

Objectives. (1) Evaluate feasibility and acceptability (recruitment, attendance, retention, satisfaction). (2) Estimate preliminary efficacy on maternal RF (primary) and explore effects on maternal symptoms and emotion regulation.

Design and Procedures. Community-recruited primiparous mothers (≥18 years; 1-5 months postpartum; fluent in Hebrew; internet access) completed baseline (T1) and were randomized 1:1 to Intervention versus Wait-List using a computer-generated schedule with concealed allocation. The intervention includes four weekly 90-minute Zoom sessions delivered by a trained clinician and brief home practices; make-up was offered for one missed session. Wait-list participants were offered the program after the post-intervention assessment. Masking of participants was not feasible; FMSS-RF transcripts were coded blind to group and time by trained raters (excellent inter-rater reliability). Outcomes are assessed at T1 (baseline) and post-intervention (T2; ~4-5 weeks after T1).

Measures.

Primary: Interview-based maternal RF (FMSS-RF global score) at T2.

Exploratory: PRFQ-CMS (self-report RF), EPDS (depressive symptoms), ERQ-Suppression, plus feasibility/acceptability indices.

Analysis. Pilot-level estimation emphasizes effect sizes and 95% confidence intervals. Primary analyses test the Group×Time effect on FMSS-RF (with mixed-models/ANCOVA adjusting for baseline); intention-to-treat analyses are planned alongside per-protocol sensitivity analyses.

Oversight and Transparency. Approved by the University of Haifa Ethics Committee (Faculty of Education; approval 350/21). Minimal risk; no data monitoring committee. The trial is retrospectively registered; the FMSS-RF at post-intervention is the pre-specified primary outcome, and other outcomes are labeled exploratory. De-identified materials and analysis code will be shared on OSF consistent with institutional policy.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 5259227
        • Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primiparous women (first-time mothers).
  • Age ≥18 years.
  • 1-5 months postpartum at enrollment.
  • Fluent in Hebrew and able to provide informed consent.
  • Internet access and a device enabling Zoom sessions.
  • Availability to attend four weekly 90-minute group sessions.

Exclusion Criteria:

  • Current psychosis, bipolar manic episode, or active suicidality requiring urgent care.
  • Substance dependence in the past 6 months.
  • Severe cognitive/neurological condition that would preclude participation.
  • Concurrent enrollment in another structured parenting/RF intervention during the trial period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Four weekly 90-minute online psycho-educational group sessions targeting maternal reflective functioning (RF), with brief home practice; make-up allowed for one missed session.
Behavioral: Thinking Emotions - Postpartum RF Group
Brief psycho-educational program to enhance maternal reflective functioning (RF): four weekly 90-minute Zoom group sessions led by a trained clinician; components include recognizing mental states, perspective-taking, reading infant cues, emotion-regulation strategies, and repair of mismatches; brief home practices between sessions.
No Intervention: Wait-List Control
Participants received usual care and were offered the same group program after completion of the post-intervention assessment (T2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in interview-based maternal reflective functioning (FMSS-RF) from baseline to post-intervention
Time Frame: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
FMSS transcripts are coded blind to group and time using the Reflective Functioning Scale (global RF score, 1-9, higher = better RF). Primary analysis tests the Group×Time effect (mixed models/ANCOVA adjusting for baseline); intention-to-treat alongside per-protocol.
Baseline (T1) and post-intervention at ~4-5 weeks (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported parental mentalization (PRFQ-Certainty About Mental States)
Time Frame: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
PRFQ-CMS subscale (Likert 1-7; higher = greater certainty about mental states). Pre-specified exploratory outcome; analyzed as change from baseline and Group×Time.
Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Change in postpartum depressive symptoms (EPDS)
Time Frame: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Edinburgh Postnatal Depression Scale (0-30; higher = more symptoms). Exploratory; analyzed as change/Group×Time.
Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Change in emotion-regulation - Expressive Suppression (ERQ-S)
Time Frame: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
ERQ Suppression subscale (Likert 1-7; higher = greater suppression). Exploratory; analyzed as change/Group×Time.
Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Recruitment and retention
Time Frame: post-intervention at ~4-5 weeks (T2)
Recruitment rate = enrolled / eligible approached (%); Retention = % completing T2;
post-intervention at ~4-5 weeks (T2)
Attendance
Time Frame: Baseline+ one week post baseline, two weeks post baseline, three weeks post baseline
Attendance = number of sessions attended (0-4)
Baseline+ one week post baseline, two weeks post baseline, three weeks post baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with adverse events related to participation
Time Frame: Baseline and 6 weeks post baseline
Self-reported adverse events collected each session and at T2; behavioral, minimal-risk program. Count and proportion of participants reporting any AE related to participation.
Baseline and 6 weeks post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Haifa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHaifa-pilot-womenpostnatal-LB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the original consent did not include public data sharing and the dataset involves a sensitive postpartum population. Aggregate results and analysis code will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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