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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help expectant single mothers improve communication and build a co-parenting bond with a support person through the Family Foundations program. Participants will join virtual sessions to learn ways to reduce stress and enhance family dynamics. The trial also examines how stress might increase inflammation by collecting small blood samples at different times. Single parents expecting through assisted reproductive technology (ART) and who have a caregiving partner, such as a grandparent or friend, are well-suited for this study. Participants will need access to a computer, tablet, or smartphone to join the online sessions. As an unphased trial, this study offers a unique opportunity to enhance family relationships and manage stress effectively.

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 prior data suggests that the Family Foundations intervention is safe for expectant single mothers?

Research has shown that the Family Foundations program is safe and well-received. Studies have found that participants often experience better support from their partners and reduced depression and anxiety in mothers. This indicates that the program aids emotional well-being and is generally safe for participants.

The program includes nine classes for expectant mothers and their support person, focusing on building healthier family relationships. Participants have reported positive experiences, such as better birth outcomes and less stress. This suggests the program is beneficial without major safety concerns.

Overall, evidence indicates that Family Foundations is a safe option for expectant mothers seeking to improve family dynamics. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Foundations program because it offers a unique approach to supporting pregnant families through structured educational sessions. Unlike traditional prenatal care, which often focuses mainly on physical health, Family Foundations emphasizes the emotional and relational aspects of pregnancy and early parenthood. This program provides nine sessions, split between prenatal and postpartum periods, to help families build strong foundations for parenting. By focusing on both the prenatal and postpartum phases, Family Foundations aims to enhance family dynamics and improve outcomes for both parents and children, offering a holistic approach that is not typically addressed in standard prenatal care.

What evidence suggests that the Family Foundations intervention is effective for improving coparenting and communication?

Research shows that the Family Foundations program offers numerous benefits. Studies have found it enhances parental cooperation and strengthens parent-child relationships. Participants reported reduced depression and anxiety, common stress-related issues during and after pregnancy. In this trial, participants will join one of two groups: immediate enrollment in the Family Foundations program or delayed enrollment. The program is associated with healthier births and reduced stress for both mothers and fathers. Overall, Family Foundations fosters a supportive environment, leading to healthier family interactions and improved mental health for parents. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3683104/

The Effects of the Family Foundations Prevention Program on ... These findings demonstrate FF's efficacy for improving both coparenting and child outcomes, but do not explain the mechanisms underlying the program's effects.

2. cebc4cw.org cebc4cw.org/program/family-foundations/detailed

CEBC » Family Foundations › Program › Detailed Results indicate that FF participants displayed significant improvement on coparental support, maternal depression and anxiety, distress in the parent-child ...

3. blueprintsprograms.org blueprintsprograms.org/programs/441999999/family-foundations/

Family Foundations Indeed, program evaluation data suggests that families enrolled in the program have demonstrated better birth outcomes (for mothers at risk due ...

4. prevention.psu.edu prevention.psu.edu/flagship_intitiative/family-foundations/

Family Foundations Overview · better birth outcomes · reduced postpartum depression · reduced postpartum weight retention · lower mother and father stress · reduced family violence, ...

5. amchp.org amchp.org/wp-content/uploads/2021/05/Family-Foundations-Practice-Handout-Best-PRACTICE-3-17-22-002.pdf

Family Foundations - MCH Innovations Database Results in the first trial indicated that Family Foundations families showed better co-parenting, lower parental stress, depression, anxiety; better birth ...

6. crimesolutions.ojp.gov crimesolutions.ojp.gov/ratedprograms/family-foundations

Program Profile: Family Foundations - CrimeSolutions.gov This is a psychoeducational, skills-based program designed for first-time expectant parents. The program is rated Promising.