Family Foundations for Individuals Pregnant Via ART

Not Applicable

Recruiting

• Conditions: Assisted Reproductive Technology

• Registration Number: NCT06770972
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

The purpose of this study is to help expectant single 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 return 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; attending 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

Not available

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Study Start: 2025-05
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-01-30
• Study Completion: 2028-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Pregnant individuals via ART, at least 18 years of age
2. Self-identify as a single parent
3. Have a caregiving partner (e.g. grandparent; nanny; friend) who will attend sessions
4. Provision of signed and dated informed consent form
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Depressive Symptoms	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).
Change in social support	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.
Change in Anxiety Symptoms	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.
Change in symptoms of perceived stress	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.
Change in communication	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).
Change in symptoms of post-traumatic stress	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 Outcome Measures

Name	Time	Method
Change in levels of high sensitivity C-reactive protein (mg/dL)	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

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States