Recruiting

Observational Study

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT06770972

Conditions

Assisted Reproductive Technology

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Family Foundations

Study Details

Brief summary:

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.

Conditions

Assisted Reproductive Technology

Study ID

NCT06770972

Start date

Jun 11, 2025

Status verified date

Dec, 2025

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Pregnant individuals via ART, at least 18 years of age
2. Have a caregiving partner (e.g. spouse, grandparent; nanny; friend) who will attend sessions
3. Provision of signed and dated informed consent form
4. Stated willingness to comply with all study procedures and availability for the duration of the study
5. English speaking

7\. Access to and familiarity with a tablet, smartphone, or computer

Exclusion Criteria:

1. Psychosis
2. Perinatal loss (current) - history of loss is OK
3. Individuals outside of the US
4. Do not have smartphones, tablets, computers (the FF class is virtual)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Family Foundations

The FF intervention is 9 sessions, 5 in the prenatal period and 4 in the postpartum period.

Primary outcome measure

  • Change in Depressive Symptoms [ Time Frame: From enrollment to the end of intervention at 6 months postpartum ]
  • Change in social support [ Time Frame: From enrollment to the end of intervention at 6 months postpartum ]
  • Change in Anxiety Symptoms [ Time Frame: From enrollment to the end of intervention at 6 months postpartum ]
  • Change in symptoms of perceived stress [ Time Frame: From enrollment to the end of intervention at 6 months postpartum ]
  • Change in communication [ Time Frame: From enrollment to the end of intervention at 6 months postpartum ]
  • Change in symptoms of post-traumatic stress [ Time Frame: From enrollment to the end of intervention at 6 months postpartum ]

Central Contacts and Locations

Central contacts

Pearl Heumann, BS

323-866-8107familyfoundations@cshs.org

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Pearl Heumann, BS

323-866-8107familyfoundations@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Assisted Reproductive Technology
  • mental health outcomes
  • pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2025-12-24.