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Completed

NCT Number: NCT07318168

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Education

Haifa, 5259227, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Thinking Emotions - Postpartum RF Group

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Recruitment and retention

    Time frame: post-intervention at ~4-5 weeks (T2)

    Recruitment rate = enrolled / eligible approached (%); Retention = % completing T2;

  5. Attendance

    Time frame: Baseline+ one week post baseline, two weeks post baseline, three weeks post baseline

    Attendance = number of sessions attended (0-4)

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

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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