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NCT Number: NCT06770972

Family Foundations for Individuals Pregnant Via ART

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.

Recruiting

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Key information

Conditions

Assisted Reproductive Technology

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Pearl Heumann, BS

CONTACT

[email protected]

323-866-8107

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Family Foundations

Behavioral

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

Primary outcomes

  1. Change in Depressive Symptoms

    Time frame: From enrollment to the end of intervention at 6 months postpartum

    Change in depression measured by the Edinburgh Postnatal Depression Scale (EPDS). This is a 10-item survey with scores ranging from 0-30 (higher number means more depressive symptoms).

  2. Change in social support

    Time frame: From enrollment to the end of intervention at 6 months postpartum

    Multidimensional Scale of Perceived Social Support (MSPSS): This is a 12-item validated screening tool assessing social support. It has a total score range of 12 to 84, with higher scores indicating higher levels of perceived social support.

  3. Change in Anxiety Symptoms

    Time frame: From enrollment to the end of intervention at 6 months postpartum

    Anxiety symptoms measured by the 5-tiem Overall Anxiety Severity and Impairment Scale (OASIS). The total score on the OASIS ranges from 0 to 20, with higher total indicating more anxiety symptoms.

  4. Change in symptoms of perceived stress

    Time frame: From enrollment to the end of intervention at 6 months postpartum

    Stress measured by the 10-item Perceived Stress Scale (PSS). The PSS score range is 0-40, with higher scores indicating higher levels of perceived stress.

  5. Change in communication

    Time frame: From enrollment to the end of intervention at 6 months postpartum

    Communication Patterns Questionnaire (CPQ): This is a 35 item self-report measure designed to assess the extent to which couples/dyads make use of various interaction strategies during conflict. Each item assesses partners' perception of how likely a certain type of behavior (e.g., both members avoid discussing the problem) occurs when faced with a relationship problem, from 1 (very unlikely) to 9 (very likely). Of the 35 items on the CPQ, 16 are currently used to form four subscales: constructive communication (7 items), self-demand/partner-withdraw (3 items), partner-demand/self-withdraw (3 items), and mutual avoidance (3 items).

  6. Change in symptoms of post-traumatic stress

    Time frame: From enrollment to the end of intervention at 6 months postpartum

    Post-traumatic Stress measured by the 22-item Impact of Event Scale-Revised (IES-R). The IES-R has a score range of 0 to 88, with higher scores indicating more stress.

Secondary outcomes

  1. Change in levels of high sensitivity C-reactive protein (mg/dL)

    Time frame: From enrollment to the end of treatment at 6 months postpartum

    C-reactive protein (CRP) levels are measured with a self-administered blood spot collection kit to indicate inflammation in the body. CRP levels can vary depending on the lab, but here are some general ranges:

    Less than 0.3 mg/dL: Normal for most healthy adults 0.3 to 1.0 mg/dL: Normal or minor elevation 1.0 to 10.0 mg/dL: Moderate elevation More than 10.0 mg/dL: Marked elevation More than 50.0 mg/dL: Severe elevation

Study contacts

Contact information is provided by the study sponsor or research team.

Pearl Heumann, BS

CONTACT

[email protected]

323-866-8107

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Family Foundations for Individuals Pregnant Via Assisted Reproductive Technology

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jan 13, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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