NCT05772897 Parenting Skills Group for Mothers With Postpartum Depression
| NCT ID | NCT05772897 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Postpartum Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2023-08-03 |
| Primary Completion | 2035-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 750 participants in total. It began in 2023-08-03 with a primary completion date of 2035-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this longitudinal study is to study the effects of a parenting skills group (Circle of Security Parenting, aka COSP) in mothers with postpartum depression. The main questions it aims to answer are: * Will changes in methylation of the OXTR rs53576 be apparent in mother and/or infant after having gone through the 8-week COSP program? * Will COSP participation be associated with improved symptoms of postpartum depression (over and above standard care), attachment style, and relational characteristics of the mother-infant dyad? * Will COSP participation be associated with changes in social behavior in the infant, and if so, do they persist throughout childhood? Participants will * Participate in an 8-week COSP program delivered remotely via Zoom. * Provide buccal swabs (mother and infant) to assess changes in methylation of OXTR rs53576 pre- versus post-intervention. * Complete a series of assessment questionnaires delivered remotely. * Videotape a play-based assessment in their home. * Receive infant developmental testing Researchers will compare characteristics of waitlist controls to those participating in the COSP program at the mid-way point of the program to see if the two groups differ.
Eligibility Criteria
Inclusion Criteria: * Mothers aged 18-50 years old with infants aged 3-14 months old * Mothers who are experiencing symptoms of depression and mothers who are not experiencing symptoms of depression (non-depressed controls) are encouraged to participate. (please note that mothers who are experiencing active depression and who are not already being treated under the care of a qualified healthcare provider (i.e. through therapy or psychopharmacological intervention) will be referred for such treatment prior to being enrolled in the study. This study is not a replacement for professional management of depression or other mental health symptoms. Exclusion Criteria: * Mothers with severe psychopathology (such as bipolar disorder, schizophrenia, personality disorders, among others) * Infants with major medical problems that may interfere with a mother's ability to participate in and benefit from the intervention
Contact & Investigator
Sunny Stophaeros, MS
PRINCIPAL INVESTIGATOR
sunny.stophaeros@ucdenver.edu
Frequently Asked Questions
Who can join the NCT05772897 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Postpartum Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05772897 currently recruiting?
Yes, NCT05772897 is actively recruiting participants. Contact the research team at sunny.stophaeros@ucdenver.edu for enrollment information.
Where is the NCT05772897 trial being conducted?
This trial is being conducted at Denver, United States.
Who is sponsoring the NCT05772897 clinical trial?
NCT05772897 is sponsored by University of Colorado, Denver. The principal investigator is Sunny Stophaeros, MS at sunny.stophaeros@ucdenver.edu. The trial plans to enroll 750 participants.
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