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

NCT ID: NCT07318168

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-10-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Thinking Emotions - Postpartum RF Group

Intervention Type: 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.

Wait-List Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Lee Barel Refaeli

Lecturer and PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Education

Haifa, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 28472162 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3651732 (View on PubMed)

Other Identifiers

UHaifa-pilot-womenpostnatal-LB

Identifier Type: -

Identifier Source: org_study_id