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

NCT07318168 | Completed

• 1 other identifier: UHaifa-pilot-womenpostnatal-LB
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Period; Maternal Mental Health; Primiparity (First-Time Mothers); Parenting / Maternal Behavior; Depressive Symptoms, Postpartum

Keywords

Maternal Reflective Functioning (RF); Mentalization / Parental Mentalization; First-Time Mothers / Primiparous; Early Postpartum; Psychoeducational Group Intervention; Telehealth / Zoom; FMSS-RF; PRFQ; EPDS; Emotion Regulation (ERQ); Feasibility / Acceptability; Israel / University of Haifa

Outcome Measures

Primary Outcomes (1)

• Change in interview-based maternal reflective functioning (FMSS-RF) from baseline to post-intervention

  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 Outcomes (5)

• Change in self-reported parental mentalization (PRFQ-Certainty About Mental States)

  Baseline (T1) and post-intervention at ~4-5 weeks (T2)

• Change in postpartum depressive symptoms (EPDS)

  Baseline (T1) and post-intervention at ~4-5 weeks (T2)

• Change in emotion-regulation - Expressive Suppression (ERQ-S)

  Baseline (T1) and post-intervention at ~4-5 weeks (T2)

• Recruitment and retention

  post-intervention at ~4-5 weeks (T2)

• Attendance

  Baseline+ one week post baseline, two weeks post baseline, three weeks post baseline

Other Outcomes (1)

• Number of Participants with adverse events related to participation

  Baseline and 6 weeks post baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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

Wait-List Control

NO INTERVENTION

Participants received usual care and were offered the same group program after completion of the post-intervention assessment (T2).

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primiparous women (first-time mothers).
• Age ≥18 years.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

Education

Haifa, 5259227, Israel

Location

Related Publications (2)

• Luyten P, Mayes LC, Nijssens L, Fonagy P. The parental reflective functioning questionnaire: Development and preliminary validation. PLoS One. 2017 May 4;12(5):e0176218. doi: 10.1371/journal.pone.0176218. eCollection 2017.

  PMID: 28472162 BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

MeSH Terms

Conditions

Depression; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors (FMSS-RF coders) were blinded to group assignment and time point; participant blinding was not feasible for a behavioral program.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and PhD candidate

Model Details: Randomized 1:1 two-arm parallel trial comparing a brief psycho-educational group intervention versus wait-list control among first-time mothers. Assessments at baseline (T1) and post-intervention (T2 \~4-5 weeks after T1). Outcome assessors (FMSS-RF coders) were blinded to group and time.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 5, 2026
• Study Start: December 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)