Family Foundations for Individuals Pregnant Via ART

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Assisted Reproductive Technology

Treatments: Behavioral: Family Foundations

Study type: Interventional

Funder types: Other

Identifiers

NCT06770972

STUDY00003470

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Family Foundations immediate enrollment

Experimental group

Description:

Administer 9 sessions of FF intervention (5 prenatal and 4 postpartum).

Treatment:

Behavioral: Family Foundations

Family Foundations delayed enrollment

No Intervention group

Description:

Administer 9 sessions of FF intervention after 3-6 month postpartum. Women will be randomized to either the delayed intervention control or FF.