Family Foundations for Individuals Pregnant Via ART
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Cedars-Sinai Medical Center
- Study ID
- NCT06770972
- Status
- Recruiting
Conditions
- Assisted Reproductive Technology
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Family Foundations — BEHAVIORALThe FF intervention is 9 sessions, 5 in the prenatal period and 4 in the postpartum period.
Study Details
The purpose of this study is to help expectant mothers build a coparenting bond and improve communication with a support person (co-caregiver). Participation will include completing two online surveys (one at 12-30 weeks gestation \& one at 3 months postpartum), providing two at-home bloodspot collections and returning the collections via mail. Studies suggest that stress increases inflammation. Investigators aim to explore this by collecting a small amount of blood at the first and last session. Participants will also attend 9 virtual one-two hour Family Foundations (FF) intervention sessions (at no cost to participants) with a supportive co-caregiver. Total time commitment will be 18 hours, max, over a 6 month period.
Key Dates
- Start date
- Jun 11, 2025
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2026
- Completion
- Jan 30, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Family Foundations immediate enrollmentAdminister 9 sessions of FF intervention (5 prenatal and 4 postpartum).
- No Intervention: Family Foundations delayed enrollmentAdminister 9 sessions of FF intervention after 3-6 month postpartum. Women will be randomized to either the delayed intervention control or FF.
Primary Outcome Measure
Change in Depressive Symptoms [ Time Frame: From enrollment to the end of intervention at 6 months postpartum ]
Central Contacts
- Pearl Heumann, BS323-866-8107
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 |