Family Foundations for Individuals Pregnant Via ART
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Family Foundations.
- Who it may be relevant to
- Registry conditions: Assisted Reproductive Technology. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Family Foundations for Individuals Pregnant Via Assisted Reproductive Technology
Overview
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.
Interventions
- Behavioral Family Foundations
The FF intervention is 9 sessions, 5 in the prenatal period and 4 in the postpartum period.
Primary outcome measures
- Change in Depressive Symptoms [Time frame: From enrollment to the end of intervention at 6 months postpartum]
- Change in social support [Time frame: From enrollment to the end of intervention at 6 months postpartum]
- Change in Anxiety Symptoms [Time frame: From enrollment to the end of intervention at 6 months postpartum]
- Change in symptoms of perceived stress [Time frame: From enrollment to the end of intervention at 6 months postpartum]
- Change in communication [Time frame: From enrollment to the end of intervention at 6 months postpartum]
- Change in symptoms of post-traumatic stress [Time frame: From enrollment to the end of intervention at 6 months postpartum]
Secondary outcome measures (1)
- Change in levels of high sensitivity C-reactive protein (mg/dL) [Time frame: From enrollment to the end of treatment at 6 months postpartum]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Cedars Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT06770972 · STUDY00003470