Family Foundations for Pregnancy

Overseen By Pearl Heumann, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Psychosis, Perinatal loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

40 Participants Needed

Trial Summary

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Family Foundations?

The Nurse-Family Partnership (NFP) model, a similar evidence-based home visiting program, has been shown to improve pregnancy outcomes, child development, and economic self-sufficiency for first-time mothers and their families. This suggests that programs like Family Foundations, which may share similar components, could also be effective in supporting families during pregnancy. ^{1 2 3 4 5}

How does the Family Foundations treatment differ from other treatments for transitioning to parenthood?

Family Foundations is unique because it focuses on helping couples navigate the transition to parenthood through a series of pre- and post-natal classes, addressing both parenting and coparenting strategies. Unlike other treatments, it emphasizes the couple's relationship and the developmental environment of the child, providing a comprehensive approach to managing the stressors of becoming new parents. ^{5 6 7 8 9}

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for single expectant mothers who used Assisted Reproductive Technology (ART), are at least 18, and speak English. They must have a caregiving partner to attend sessions with them, agree to study procedures, and be available for the duration of the study. Participants need access to technology like a tablet or computer.

Inclusion Criteria

I have signed and agreed to the informed consent form.

I am a single parent.

I am willing and able to follow all study rules and attend all appointments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend 9 virtual Family Foundations intervention sessions with a supportive co-caregiver over a 6 month period

6 months

9 virtual sessions

Follow-up

Participants are monitored for changes in depressive symptoms, anxiety, social support, perceived stress, communication, and post-traumatic stress

6 months postpartum

Treatment Details

Interventions

• Family Foundations

Trial Overview The Family Foundations program is being tested in this trial. It aims to help single mothers using ART build coparenting relationships and improve communication with their support person through nine virtual sessions over six months, along with two online surveys and bloodspot collections.

Participant Groups

Group I: Family Foundations immediate enrollment Experimental Treatment 1 Intervention

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

Group II: Family Foundations delayed enrollment Active Control 1 Intervention

Administer 9 sessions of FF intervention after 3-6 month postpartum. Women will be randomized to either the delayed intervention control or FF.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

The article introduces a new advanced practice role in outcomes management specifically for the perinatal population, emphasizing the importance of coordinated care among diverse healthcare teams.

Over a 3-year period, the implementation of this outcomes management approach led to significant improvements in clinical, functional, service quality, and financial outcomes, highlighting its effectiveness in enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new advanced practice role focused on outcomes management in women's and children's health. Terhaar, M., O'Keefe, S.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The process and promise of mental health augmentation of nurse home-visiting programs: Data from the Louisiana Nurse-Family Partnership. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A new advanced practice role focused on outcomes management in women's and children's health. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Families in crisis due to multiple trauma. [2004]

4. United States pubmed.ncbi.nlm.nih.gov

Improved perinatal outcomes with perinatal case management. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Engaging Community in Prioritizing Outcomes to Improve Family Health in Evidence-Based Nurse Home Visiting: Using a Modified e-Delphi Method. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Family and Child Outcomes 2 Years After a Transition to Parenthood Intervention. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Preparing expectant couples for new-parent experiences: a comparison of two models of antenatal education. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The polomeno family intervention framework for perinatal education: preparing couples for the transition to parenthood. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Costs to implement an effective transition-to-parenthood program for couples: analysis of the Family Foundations program. [2022]