Assisted Reproductive TechnologyNCT06770972
Family Foundations for Individuals Pregnant Via ART
A study testing Family Foundations in people with Assisted Reproductive Technology, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Assisted Reproductive Technology
- What is being tested?
- Family Foundations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 7. Access to and familiarity with a tablet, smartphone, or computer
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Pearl Heumann, BS, 323-866-8107, familyfoundations@cshs.org
About this study
Official title: Family Foundations for Individuals Pregnant Via Assisted Reproductive Technology
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
- Being tested
- Family Foundations
- Keywords
- Assisted Reproductive Technology, mental health outcomes, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family FoundationsBehavioural
The FF intervention is 9 sessions, 5 in the prenatal period and 4 in the postpartum period.
| Study group | Role | What they receive |
|---|---|---|
| Family Foundations immediate enrollment | Experimental | Administer 9 sessions of FF intervention (5 prenatal and 4 postpartum). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
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
Measured: From enrollment to the end of treatment at 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start11 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eynav Accortt, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770972
- Sponsor's protocol ID
- STUDY00003470
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Foundations for Individuals Pregnant Via Assisted Reproductive Technology
- ClinicalTrials.gov ID
- NCT06770972
- Acronym / sponsor ID
- STUDY00003470
- Conditions
- Assisted Reproductive Technology
- Keywords
- Assisted Reproductive Technology, mental health outcomes, pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Foundations immediate enrollment | Experimental | Behavioral: Family FoundationsAdminister 9 sessions of FF intervention (5 prenatal and 4 postpartum). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family FoundationsThe FF intervention is 9 sessions, 5 in the prenatal period and 4 in the postpartum period. | Behavioural | Family Foundations immediate enrollment |
Primary outcome
Change in Depressive Symptoms
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Change in levels of high sensitivity C-reactive protein (mg/dL)
Time frame: From enrollment to the end of treatment at 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Foundations in people with Assisted Reproductive Technology, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pearl Heumann, BS (323-866-8107, familyfoundations@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms (time frame: From enrollment to the end of intervention at 6 months postpartum). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.