Family Foundations for Individuals Pregnant Via ART

NCT06770972 | Recruiting

• 1 other identifier: STUDY00003470
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Assisted Reproductive Technology; mental health outcomes; pregnancy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

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

  From enrollment to the end of treatment at 6 months postpartum

Study Arms (2)

Family Foundations immediate enrollment

EXPERIMENTAL

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

Behavioral: Family Foundations

Family Foundations delayed enrollment

NO INTERVENTION

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 BEHAVIORAL

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

Family Foundations immediate enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Central Study Contacts

Pearl Heumann, BS

CONTACT

323-866-8107; familyfoundations@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 13, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)