Family Foundations for Individuals Pregnant Via ART

NCT ID: NCT06770972

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-11

Study Completion Date

2028-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Assisted Reproductive Technology

Keywords

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Assisted Reproductive Technology mental health outcomes pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Family Foundations immediate enrollment

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

Group Type EXPERIMENTAL

Family Foundations

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Family Foundations

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eynav Accortt

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pearl Heumann, BS

Role: CONTACT

Phone: 323-866-8107

Email: [email protected]

Facility Contacts

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Pearl Heumann, BS

Role: primary

Other Identifiers

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STUDY00003470

Identifier Type: -

Identifier Source: org_study_id