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 — BEHAVIORAL
    The 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 enrollment
    Administer 9 sessions of FF intervention (5 prenatal and 4 postpartum).
  • No Intervention: Family Foundations delayed enrollment
    Administer 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

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Pearl Heumann, BS
323-866-8107

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