Family Foundations for Individuals Pregnant Via ART
ConditionAssisted Reproductive Technology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCedars-Sinai Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Family Foundations
BehavioralThe FF intervention is 9 sessions, 5 in the prenatal period and 4 in the postpartum period.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Family Foundations immediate enrollmentExperimental treatment 1 intervention
Group B: Family Foundations delayed enrollmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
From enrollment to the end of intervention at 6 months postpartum2
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.
Time frame
From enrollment to the end of intervention at 6 months postpartum3
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.
Time frame
From enrollment to the end of intervention at 6 months postpartum4
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.
Time frame
From enrollment to the end of intervention at 6 months postpartumSecondary 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
Time frame
From enrollment to the end of treatment at 6 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov