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Behavioral Intervention

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

N/A
Waitlist Available
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

PMAD-CARE Trial Summary

This trial will test if a 12-session group therapy can help postpartum parents manage their mental health, parenting stress, and connection with their baby. Eligible parents must have a baby 3-12 months old and have experienced postpartum depression/anxiety.

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.Check my eligibility
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.See study design
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.

PMAD-CARE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change from Baseline to Post-Treatment in Infant Temperament

PMAD-CARE 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?

Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,175 Total Patients Enrolled
American Psychological FoundationOTHER
18 Previous Clinical Trials
1,886 Total Patients Enrolled
1 Trials studying Postpartum Depression
50 Patients Enrolled for Postpartum Depression
Amanda Zayde, Psy.D.Principal InvestigatorMontefiore Medical Center/Albert Einstein College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts for this research still ongoing?

"Data accessed from clinicaltrials.gov indicates that this medical research project is not currently recruiting patients, having last been updated on September 14th 2023. However, there are still 1237 other active trials at present seeking volunteers."

Answered by AI

What prerequisites must be met to become eligible for this trial?

"The requirements for this study demand that participants have been diagnosed with postpartum depression and are aged between 18-70. It is currently enlisting a cohort of 21 individuals."

Answered by AI

Does this trial accommodate individuals over the age of 30?

"This medical research initiative is recruiting participants aged between 18 and 70. Those who are under the age of 18 have 200 trials they can join, while those over 65 can choose from 902 clinical studies."

Answered by AI
~14 spots leftby Dec 2025