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Behavioral Intervention

CARE Program for Postpartum Mental Health (PMAD-CARE Trial)

N/A
Recruiting
Led By Amanda Zayde, Psy.D.
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a group therapy program called CARE for parents with postpartum depression or anxiety. The program helps parents understand their own and their baby's thoughts and feelings to improve mental health and reduce stress. The study targets parents with infants aged 3 to 12 months who are receiving care at Montefiore Medical Center.

Who is the study for?
This trial is for postpartum parents who have given birth within the last 3-12 months, are English-speaking, and are currently receiving care at Montefiore Medical Center. It's aimed at those experiencing moderate to high levels of depression or anxiety after childbirth. Parents already in a CARE group or another parenting program, with severe mental health issues needing intense treatment, or current psychosis/mania can't participate.
What is being tested?
The study tests the Connecting and Reflecting Experience (CARE) Program—a group therapy designed to improve mental health, reduce parenting stress, and strengthen parent-infant relationships among postpartum parents with mood/anxiety disorders. Participants will attend 12 sessions and complete surveys to assess the program's impact on their well-being.
What are the potential side effects?
As this is a psychological intervention rather than a medical one, traditional side effects like those seen with medications aren't expected. However, discussing sensitive topics during therapy could potentially cause emotional discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline to Post-Treatment in Parent-Infant Bonding
Change from Baseline to Post-Treatment in Parental Reflective Functioning
Change from Baseline to Post-Treatment in Parenting Stress Score
+4 more
Secondary study objectives
Change from Baseline to Post-Treatment in Infant Temperament

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Connecting and Reflecting Experience (CARE) ProgramExperimental Treatment1 Intervention
Participants will enroll in a 12-session CARE parenting group therapy.

Find a Location

Who is running the clinical trial?

American Psychological FoundationOTHER
18 Previous Clinical Trials
1,896 Total Patients Enrolled
Montefiore Medical CenterLead Sponsor
456 Previous Clinical Trials
588,449 Total Patients Enrolled
Amanda Zayde, Psy.D.Principal InvestigatorMontefiore Medical Center/Albert Einstein College of Medicine
~14 spots leftby Jun 2025