Family Foundations for Individuals Pregnant Via ART

This study is testing a program called Family Foundations (FF) for pregnant individuals who conceived using Assisted Reproductive Technology (ART). The FF program involves 9 virtual sessions, some before and some after birth, to help expectant mothers and a support person (like a partner or friend) build a strong co-parenting bond and improve communication. Researchers want to see if this program can reduce symptoms of depression and anxiety, and improve social support, over a 6-month period after enrollment. You can join if you are at least 18 years old, pregnant via ART, have a caregiving partner who will attend sessions, and speak English. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 40 participants. It is not specified if the study is randomized or blinded.
What's involved
You would complete two online surveys, provide two at-home bloodspot collections, and attend 9 virtual Family Foundations sessions. The total time commitment is up to 18 hours over a 6-month period.
Compensation
The Family Foundations intervention sessions are at no cost to participants. Not stated in the trial record if participants are otherwise compensated.
Follow-up
Participants will be followed from enrollment until the end of the intervention at 6 months postpartum.

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NCT06770972

Family Foundations for Individuals Pregnant Via ART

Recruiting
NAAges 18+Interventional
Cedars-Sinai Medical Center
~40 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:Family Foundations

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Depressive Symptoms
Measured over From enrollment to the end of intervention at 6 months postpartum
+5 more outcomes measured
Assisted Reproductive Technology
1 sites across 1 states
California1

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  • Change in Depressive SymptomsFrom 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 supportFrom 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 SymptomsFrom 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 stressFrom 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 communicationFrom 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 stressFrom 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.