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Not recruiting

Parenting Program

Sponsor:

Montefiore Medical Center

Code:

NCT06042166

Conditions

Postpartum Depression

Postpartum Anxiety

Parenting Stress

Parent Child Relationships

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Connecting and Reflecting Experience (CARE) Program

Study Details

Brief 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. 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.

Conditions

Postpartum Depression

Postpartum Anxiety

Parenting Stress

Parent Child Relationships

Study ID

NCT06042166

Start date

Aug 16, 2024

Status verified date

Jul, 2025

Completion date

Oct 15, 2025

Anticipated

Primary completion date

Oct 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Birthing parent (of any gender) of an infant age 3-12 months old at baseline
  • 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

Exclusion Criteria:

  • 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
  • Psychiatric, neurocognitive, or substance use related difficulties necessitating a higher level of care than outpatient support (e.g., current inpatient treatment) or that would impede group participation (e.g., severe cognitive impairment)

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Connecting and Reflecting Experience (CARE) Program

Participants will enroll in a 12-session CARE parenting group therapy.

Interventions

Connecting and Reflecting Experience (CARE) Program

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.

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). ]
  • Change from Baseline to Post-Treatment in Postpartum Depression Score [ Time Frame: 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). ]
  • Change from Baseline to Post-Treatment in Parenting Stress Score [ Time Frame: 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). ]
  • Change from Baseline to Post-Treatment in Parental Reflective Functioning [ Time Frame: 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). ]
  • Change from Baseline to Post-Treatment in Parent-Infant Bonding [ Time Frame: 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). ]
  • Post-treatment rating of treatment acceptability and feasibility [ Time Frame: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement). ]
  • Change from Session 1 to Session 12 in Therapeutic Group Processes [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Olivia J Derella, Ph.D.

718-304-7022olivia.derella@einsteinmed.edu

Amanda Zayde, Psy.D.

718-304-7128azayde@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10470

Contacts

Olivia J. Derella, Ph.D.

718-304-7022CAREprogram@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jul 11, 2025

Last verified

Jul, 2025

Keywords

  • postpartum depression
  • group therapy
  • parenting stress
  • short-term therapy
  • parenting support
  • postpartum anxiety
  • perinatal mood and anxiety disorders
  • mentalizing
  • parental reflective functioning
  • attachment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2025-07-11.