Education
Haifa, 5259227, Israel
NCT Number: NCT07318168
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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Notify Me18 year and older
Female
Interventional
Not applicable
Haifa, 5259227, Israel
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: post-intervention at ~4-5 weeks (T2)
Recruitment rate = enrolled / eligible approached (%); Retention = % completing T2;
Time frame: Baseline+ one week post baseline, two weeks post baseline, three weeks post baseline
Attendance = number of sessions attended (0-4)
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.
University of Haifa
Other
Randomized Controlled Pilot Trial of a Brief Psycho-educational Intervention to Enhance Maternal Reflective Functioning in the Early Postpartum Among First-Time Mothers
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