Assisted Reproductive Technology
Conditions
Keywords
Assisted Reproductive Technology, mental health outcomes, pregnancy
Brief 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 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
BEHAVIORALFamily Foundations
The FF intervention is 9 sessions, 5 in the prenatal period and 4 in the postpartum period.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant individuals via ART, at least 18 years of age 2. Have a caregiving partner (e.g. spouse, grandparent; nanny; friend) who will attend sessions 3. Provision of signed and dated informed consent form 4. Stated willingness to comply with all study procedures and availability for the duration of the study 5. English speaking 7\. Access to and familiarity with a tablet, smartphone, or computer
Exclusion criteria
1. Psychosis 2. Perinatal loss (current) - history of loss is OK 3. Individuals outside of the US 4. Do not have smartphones, tablets, computers (the FF class is virtual)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Symptoms | 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 Depressive Symptoms | 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 | 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 symptoms of post-traumatic stress | 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. |
| Change in symptoms of perceived stress | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in levels of high sensitivity C-reactive protein (mg/dL) | From enrollment to the end of treatment at 6 months postpartum | 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 |
Countries
United States
Contacts
Primary ContactPearl Heumann, BS
Outcome results
None listed