The postnatal period involves significant emotional and relational shifts that can challenge early mother–infant interactions, particularly under conditions of psychosocial vulnerability (e.g., maternal anxiety/depression) or infant-related risk (e.g., preterm birth). Maternal mentalization, operationalized as Parental Reflective Functioning (PRF), is a key protective factor for sensitive caregiving and dyadic regulation. Objectives: This protocol describes a multicenter, open-label, single-arm feasibility study evaluating a brief, fully online, mentalization-based video-feedback intervention (VFI-RF). The study is designed to assess the feasibility and acceptability of the intervention, rather than its efficacy. We aim to recruit 48 mothers, 24 in each of two risk groups, through socio-health services and neonatal intensive care units. Risk Group 1 will include mothers with clinically significant depressive and/or anxiety symptoms, defined as EPDS > 9 and/or GAD-7 ≥ 10, whereas Risk Group 2 will include mothers of preterm infants, defined as infants born before 37 weeks of gestation. Methods: The intervention consists of 8 + 2 synchronous online sessions over approximately 5 months. Mothers record brief everyday caregiving interactions (~5 min) to review with a trained clinician, focusing on the infant’s internal states and reflective meaning-making. Assessments occur at baseline (T0, infant age ~3 months), post-intervention (T1, ~8 months), and follow-up (T2, ~12 months). Primary feasibility outcomes include recruitment/referral metrics, uptake, retention, assessment completion, missing data, and participant-reported acceptability. Secondary exploratory clinical outcomes include maternal PRF, symptoms, parenting stress, social support, and mother–infant attachment, evaluated via validated self-report questionnaires. Results: The study is designed to evaluate referral and recruitment patterns, intervention uptake, and participant retention, as well as the acceptability and suitability of study procedures and outcome measures for a future controlled trial. Preliminary trajectories of change in maternal reflective functioning and early relational indicators will be examined descriptively and exploratorily. Conclusions: Findings will inform the feasibility and refinement of a brief online mentalization-based video-feedback intervention to support at-risk mother–infant dyads during the first postnatal year. Trial registration: Registered on Open Science Framework, osf.io/6g9ja, date of registration 4th March 2026.
A Brief Online Mentalization-Based Video-Feedback Intervention (VFI-RF) for Mother–Infant Interaction in Postnatal Risk Conditions: Protocol for a Multicenter Single-Arm Feasibility Study / Mazza, C., Favieri, F., Lombardi, L., Trumello, C., Fiorenza, E., La Stella, M., Della Vedova, A.M., Babore, A., Tambelli, R.. - In: JOURNAL OF CLINICAL MEDICINE. - ISSN 2077-0383. - 15:13(2026). [10.3390/jcm15135271]
A Brief Online Mentalization-Based Video-Feedback Intervention (VFI-RF) for Mother–Infant Interaction in Postnatal Risk Conditions: Protocol for a Multicenter Single-Arm Feasibility Study
Mazza, Cristina;Fiorenza, Eleonora;La Stella, Michela;Tambelli, Renata
2026
Abstract
The postnatal period involves significant emotional and relational shifts that can challenge early mother–infant interactions, particularly under conditions of psychosocial vulnerability (e.g., maternal anxiety/depression) or infant-related risk (e.g., preterm birth). Maternal mentalization, operationalized as Parental Reflective Functioning (PRF), is a key protective factor for sensitive caregiving and dyadic regulation. Objectives: This protocol describes a multicenter, open-label, single-arm feasibility study evaluating a brief, fully online, mentalization-based video-feedback intervention (VFI-RF). The study is designed to assess the feasibility and acceptability of the intervention, rather than its efficacy. We aim to recruit 48 mothers, 24 in each of two risk groups, through socio-health services and neonatal intensive care units. Risk Group 1 will include mothers with clinically significant depressive and/or anxiety symptoms, defined as EPDS > 9 and/or GAD-7 ≥ 10, whereas Risk Group 2 will include mothers of preterm infants, defined as infants born before 37 weeks of gestation. Methods: The intervention consists of 8 + 2 synchronous online sessions over approximately 5 months. Mothers record brief everyday caregiving interactions (~5 min) to review with a trained clinician, focusing on the infant’s internal states and reflective meaning-making. Assessments occur at baseline (T0, infant age ~3 months), post-intervention (T1, ~8 months), and follow-up (T2, ~12 months). Primary feasibility outcomes include recruitment/referral metrics, uptake, retention, assessment completion, missing data, and participant-reported acceptability. Secondary exploratory clinical outcomes include maternal PRF, symptoms, parenting stress, social support, and mother–infant attachment, evaluated via validated self-report questionnaires. Results: The study is designed to evaluate referral and recruitment patterns, intervention uptake, and participant retention, as well as the acceptability and suitability of study procedures and outcome measures for a future controlled trial. Preliminary trajectories of change in maternal reflective functioning and early relational indicators will be examined descriptively and exploratorily. Conclusions: Findings will inform the feasibility and refinement of a brief online mentalization-based video-feedback intervention to support at-risk mother–infant dyads during the first postnatal year. Trial registration: Registered on Open Science Framework, osf.io/6g9ja, date of registration 4th March 2026.| File | Dimensione | Formato | |
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