Postpartum PeriodNCT07318168
Brief Psycho-educational Intervention to Enhance Maternal Reflective Functioning in the Early Postpartum Among Primiparous: Pilot Study
A study testing Thinking Emotions - Postpartum RF Group in people with Postpartum Period and Maternal Mental Health, run by University of Haifa at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Period, Maternal Mental Health, Parenting / Maternal Behavior
- What is being tested?
- Thinking Emotions - Postpartum RF Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2021to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Pilot Trial of a Brief Psycho-educational Intervention to Enhance Maternal Reflective Functioning in the Early Postpartum Among First-Time Mothers
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.
Read the 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
- Being tested
- Thinking Emotions - Postpartum RF Group
- 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
- Medical subject headings
- Depression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinking Emotions - Postpartum RF GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Secondary outcomes (5)
Change in self-reported parental mentalization (PRFQ-Certainty About Mental States)
PRFQ-CMS subscale (Likert 1-7; higher = greater certainty about mental states). Pre-specified exploratory outcome; analyzed as change from baseline and Group×Time.
Measured: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Change in postpartum depressive symptoms (EPDS)
Edinburgh Postnatal Depression Scale (0-30; higher = more symptoms). Exploratory; analyzed as change/Group×Time.
Measured: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Change in emotion-regulation - Expressive Suppression (ERQ-S)
ERQ Suppression subscale (Likert 1-7; higher = greater suppression). Exploratory; analyzed as change/Group×Time.
Measured: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Recruitment and retention
Recruitment rate = enrolled / eligible approached (%); Retention = % completing T2;
Measured: post-intervention at ~4-5 weeks (T2)
Attendance
Attendance = number of sessions attended (0-4)
Measured: Baseline+ one week post baseline, two weeks post baseline, three weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Dec 2021
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Barel Refaeli, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318168
- Sponsor's protocol ID
- UHaifa-pilot-womenpostnatal-LB
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the original consent did not include public data sharing and the dataset involves a sensitive postpartum population. Aggregate results and analysis code will be shared.
Publications
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.
PubMed 28472162Cox 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.
PubMed 3651732
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Trial of a Brief Psycho-educational Intervention to Enhance Maternal Reflective Functioning in the Early Postpartum Among First-Time Mothers
- ClinicalTrials.gov ID
- NCT07318168
- Acronym / sponsor ID
- UHaifa-pilot-womenpostnatal-LB
- Conditions
- Postpartum Period, Maternal Mental Health, Parenting / Maternal Behavior, Primiparity (First-Time Mothers), 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Thinking Emotions - Postpartum RF GroupFour weekly 90-minute online psycho-educational group sessions targeting maternal reflective functioning (RF), with brief home practice; make-up allowed for one missed session. |
| Wait-List Control | No intervention | –Participants received usual care and were offered the same group program after completion of the post-intervention assessment (T2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thinking Emotions - Postpartum RF GroupBrief 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. | Behavioural | Intervention |
Primary outcome
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.
5 secondary outcomes
Change in self-reported parental mentalization (PRFQ-Certainty About Mental States)
Time frame: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Change in postpartum depressive symptoms (EPDS)
Time frame: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Change in emotion-regulation - Expressive Suppression (ERQ-S)
Time frame: Baseline (T1) and post-intervention at ~4-5 weeks (T2)
Recruitment and retention
Time frame: post-intervention at ~4-5 weeks (T2)
Attendance
Time frame: Baseline+ one week post baseline, two weeks post baseline, three weeks post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 28472162Luyten 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.
- Background: PubMed 3651732Cox 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the original consent did not include public data sharing and the dataset involves a sensitive postpartum population. Aggregate results and analysis code will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thinking Emotions - Postpartum RF Group in people with Postpartum Period and Maternal Mental Health, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07318168, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.