Family Foundations for Individuals Pregnant Via ART

Family Foundations for Individuals Pregnant Via Assisted Reproductive Technology

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.

Study Overview

• Status: Recruiting
• Conditions: Assisted Reproductive Technology
• Intervention / Treatment: Behavioral: Family Foundations

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pearl Heumann, BS; Phone Number: 323-866-8107; Email: familyfoundations@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai Medical Center
      • Contact: Pearl Heumann, BS; Phone Number: 323-866-8107; Email: familyfoundations@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Foundations immediate enrollment; Administer 9 sessions of FF intervention (5 prenatal and 4 postpartum).	Behavioral: Family Foundations; The FF intervention is 9 sessions, 5 in the prenatal period and 4 in the postpartum period.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depressive Symptoms	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).	From enrollment to the end of intervention at 6 months postpartum
Change in social support	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.	From enrollment to the end of intervention at 6 months postpartum
Change in Anxiety Symptoms	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.	From enrollment to the end of intervention at 6 months postpartum
Change in symptoms of perceived stress	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.	From enrollment to the end of intervention at 6 months postpartum
Change in communication	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).	From enrollment to the end of intervention at 6 months postpartum
Change in symptoms of post-traumatic stress	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.	From enrollment to the end of intervention at 6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in levels of high sensitivity C-reactive protein (mg/dL)	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	From enrollment to the end of treatment at 6 months postpartum

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Assisted Reproductive Technology; pregnancy; mental health outcomes
• Other Study ID Numbers: STUDY00003470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No