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Postpartum DepressionPMAD-CARENCT06042166

A Postpartum Adaptation Study of the Connecting and Reflecting Experience Parenting Program

A study testing Connecting and Reflecting Experience (CARE) Program in people with Postpartum Depression and Postpartum Anxiety, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Experiencing postpartum mood and/or anxiety disorders (like postpartum depression; PMADs) can make parenting challenging, but group therapy may help both these parents and their babies. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Connecting and Reflecting Experience (CARE) Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
16 Aug 2024to 11 Nov 2025
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Birthing parent (of any gender) of an infant age 3-12 months old at time of enrollment
  • Receiving postpartum OB/GYN or mental health services at Montefiore Medical Center
  • Experienced or currently experiencing moderate to high levels of depression and/or anxiety symptoms in the postpartum period
  • English-speaking

Who cannot join

  • Prior participation in a Connecting and Reflecting Experience (CARE) group at any time
  • Participation in another parenting-focused group during the current postpartum period
  • Current episode of psychosis or mania or active suicidal ideation
  • Serious psychiatric, neurocognitive, or substance use related difficulties necessitating a higher level of care than outpatient support (e.g., current inpatient treatment) or that, in the judgment of the PI, would impede group participation (e.g., severe cognitive impairment)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Montefiore Medical Center

    The Bronx, New York, 10470

Other trials in United States

About this study

Experiencing postpartum mood and/or anxiety disorders (like postpartum depression; PMADs) can make parenting challenging, but group therapy may help both these parents and their babies. This study will test whether postpartum parents with PMADs find a 12-session parenting group therapy to be likable, doable, and helpful for mental health, parenting stress, and relationship with their infant. The therapy that is being tested is called the Connecting and Reflecting Experience (CARE) parenting program, which has not yet been used specifically with postpartum parents with PMADs, but has been found to be appealing and helpful among parents/caregivers of older children with mental health conditions. CARE focuses on parents' ability to consider how their own and their children's thoughts, feelings, intentions, and other mental states shape behavior and parent-child relationships. Participants in the study will be asked to fill out surveys before, during, and after participating in the group therapy. Adults may be eligible to participate in the study if they gave birth to an infant who is now 3 to 12 months old, are receiving postpartum medical and/or mental health care at Montefiore Medical Center, and have experienced postpartum depression and/or anxiety.

Being tested
Connecting and Reflecting Experience (CARE) Program
Keywords
postpartum depression, group therapy, parenting stress, short-term therapy, parenting support, postpartum anxiety, perinatal mood and anxiety disorders, mentalizing, parental reflective functioning, attachment
Medical subject headings
Depression, Postpartum, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Connecting and Reflecting Experience (CARE) ProgramBehavioural

    The intervention consists of a 12-session mentalizing-focused parenting group, which will involve weekly one-hour telehealth therapy sessions with up to 7 postpartum parents per group and 1 to 2 facilitators. CARE is a therapy focused on parents' reflective capacity, or the ability to consider how our own and our children's thoughts, feelings, intentions, and other mental states shape behavior and parent-child relationships.

Study groups in NCT06042166
Study groupRoleWhat they receive
Connecting and Reflecting Experience (CARE) ProgramExperimentalParticipants will enroll in a 12-session CARE parenting group therapy.
Receives: Behavioral: Connecting and Reflecting Experience (CARE) Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline to Post-Treatment in Postpartum Anxiety Score

    Change in postpartum anxiety will be measured using the total score on a self-reported questionnaire: the 21-item Beck Anxiety Inventory (BAI; Beck et al, 1988). Total scores range from 0 to 63, with higher scores indicating higher anxiety symptoms.

    Measured: The BAI will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).

  2. Change from Baseline to Post-Treatment in Postpartum Depression Score

    Change in postpartum depression will be measured using the total score on a self-reported questionnaire: the Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden, \& Sagovsky, 1987). Total scores range from 0 to 30, with higher scores indicating higher depression symptoms.

    Measured: The EPDS will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).

  3. Change from Baseline to Post-Treatment in Parenting Stress Score

    Change in parenting stress will be measured using the total score on a self-reported questionnaire: the 36-item Parenting Stress Index, Short-Form (PSI-SF; Abidin, 2012). Total scores range from 36 to 180. Raw scores can be converted to percentile based on a normed sample. Higher raw and percentile scores indicate higher levels of parenting stress. Scores falling between the 16th and 84th percentiles are considered within the normal range of parenting stress, scores between the 85th and 89th percentiles are considered high, and scores at the 90th percentile and above are considered in the clinically significant range.

    Measured: The PSI-SF will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).

  4. Change from Baseline to Post-Treatment in Parental Reflective Functioning

    Change in parental reflective functioning will be measured using subscale scores on a self-reported questionnaire: the 18-item Parental Reflective Functioning Questionnaire (PRFQ; Luyten et al., 2017). The PRFQ has three subscales, each of which has a score range from 6 to 42. Though threshold scores have not been established for the PRFQ, "adaptive" subscale scores would be in the mid-range for Certainty about Mental States, low range for Prementalizing Modes, and high range for Interest and Curiosity about Mental States.

    Measured: The PRFQ will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).

  5. Change from Baseline to Post-Treatment in Parent-Infant Bonding

    Change in parent-infant bonding will be measured using subscale scores on a self-reported questionnaire: the 25-item Postpartum Bonding Questionnaire (PBQ; Brockington et al., 2001). The PBQ has 4 subscales. Scale 1 (12 items) has a score range from 0 to 60; scores above 12 are considered "high" in impaired bonding. Scale 2 (7 items) has a score range from 0 to 35; scores above 17 are considered "high" in relational rejection/anger. Scale 3 (4 items) has a score range from 0 to 20; scores above 10 are considered "high" in anxiety about infant care. Scale 4 (2 items) has a range from 0 to 10; scores above 3 are considered "high" in aggression risk.

    Measured: The PBQ will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).

  6. Post-treatment rating of treatment acceptability and feasibility

    Participants will complete a brief self-reported survey developed for this study to assess their perceptions of treatment acceptability and feasibility. Participants will rate their sense of satisfaction, enjoyment, helpfulness, and comfort with the CARE group program on a scale from 0 to 10, where higher scores indicate greater treatment acceptability. Participants will also rate how challenging aspects of group were (i.e., attendance and emotional content) from 0 to 10, where higher scores indicate lower program feasibility/greater challenge. Participants will also be asked to provide qualitative feedback regarding their impressions of the program.

    Measured: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).

  7. Change from Session 1 to Session 12 in Therapeutic Group Processes

    Change in therapeutic group processes will be measured using subscales on a self-reported questionnaire: the revised Therapeutic Factors Inventory-19 item version (TFI-19; Joyce et al., 2011). Each item is scored from 1 to 7. Subscale scores are generated as an average/mean of item ratings. Higher subscale scores indicate greater perceptions of indicated therapeutic factors within their CARE group: Instillation of Hope (4 items), Secure Emotional Expression (7 items), Awareness of Relational Impact (5 items), and Social Learning (3 items).

    Measured: The TFI-19 will be administered after participants complete Session 1 of group (approximately 0-2 weeks after baseline measurement) and again at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).

Secondary outcomes (1)

  1. Change from Baseline to Post-Treatment in Infant Temperament

    Change in infant temperament will be measured using a parent-reported questionnaire: the 37-item Infant Behavior Questionnaire, Revised, Very Short Form (IBQ-VSF; Putnam et al., 2014). The IBQ-VSF has 3 subscales for which mean scores ranging from 1 to 7 are generated. The Surgency subscale has 13 items; higher scores indicate greater infant emotional surgency. The Negative Affect subscale has 12 items; higher scores indicate greater infant negative affect. The Effortful Control subscale has 12 items; higher scores indicate greater infant effortful control.

    Measured: The IBQ-VSF will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2023
  2. Study start16 Aug 2024
  3. Primary completion11 Nov 2025
  4. Study completion11 Nov 2025

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06042166
Sponsor's protocol ID
2023-15124
Other IDs
2023
Acronym
PMAD-CARE
Status last verified
Jul 2026
First submitted
6 Sep 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study is a small pilot and thus data sharing is not appropriate at this stage.

Publications

  • Zayde A, Kilbride A, Kucer A, Willis HA, Nikitiades A, Alpert J, Gabbay V. Connection During COVID-19: Pilot Study of a Telehealth Group Parenting Intervention. Am J Psychother. 2022 Jun 15;75(2):67-74. doi: 10.1176/appi.psychotherapy.20210005. Epub 2021 Sep 16.

    PubMed 34525847

  • Zayde A, Derella OJ, Kilbride A. Safe haven in adolescence: Improving parental reflective functioning and youth attachment and mental health with the Connecting and Reflecting Experience. Infant Ment Health J. 2023 Mar;44(2):268-283. doi: 10.1002/imhj.22042. Epub 2023 Mar 2.

    PubMed 36862314

  • Zayde A, Prout TA, Kilbride A, Kufferath-Lin T. The Connecting and Reflecting Experience (CARE): theoretical foundation and development of mentalizing-focused parenting groups. Attach Hum Dev. 2021 Jun;23(3):293-309. doi: 10.1080/14616734.2020.1729213. Epub 2020 Feb 19.

    PubMed 32072881

  • Putnam SP, Helbig AL, Gartstein MA, Rothbart MK, Leerkes E. Development and assessment of short and very short forms of the infant behavior questionnaire-revised. J Pers Assess. 2014;96(4):445-58. doi: 10.1080/00223891.2013.841171. Epub 2013 Nov 9.

    PubMed 24206185

  • 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 28472162

  • Goodman JH, Santangelo G. Group treatment for postpartum depression: a systematic review. Arch Womens Ment Health. 2011 Aug;14(4):277-93. doi: 10.1007/s00737-011-0225-3. Epub 2011 Jul 1.

    PubMed 21720793

  • Brockington IF, Oates J, George S, Turner D, Vostanis P, Sullivan M, Loh C, Murdoch C. A screening questionnaire for mother-infant bonding disorders. Archives of Women's Mental Health. 2001; 3: 133-140.

  • Beck, AT, Steer, RA. Beck Anxiety Inventory Manual. San Antonio, TX: Psychological Corporation. 1993.

  • Abidin, R. R. (2012). Parenting Stress Index (4th ed.). Lutz, FL: PAR.

  • 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.

    PubMed 3651732

  • Joyce AS, MacNair-Semands R, Tasca GA, Ogrodniczuk JS. Factor structure and validity of the Therapeutic Factors Inventory-Short Form. Group Dynamics. 2011; 15(3): 201-219.

Questions about this trial

What is this clinical trial studying?

A study testing Connecting and Reflecting Experience (CARE) Program in people with Postpartum Depression and Postpartum Anxiety, run by Montefiore Medical Center at 1 site in United States.

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 4 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 22 Jul 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 United States. 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 from Baseline to Post-Treatment in Postpartum Anxiety Score (time frame: The BAI will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).). The study lists 7 primary outcomes in all. 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 NCT06042166, which also lists 11 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 22 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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