The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings

Table 3 Patient Participant-Level Measures

Outcome/ Endpoint	Measure	Administration	Time Points*
			0–24 wks GA	32–40 wks GA	1–3 mos PP	5–7 mos PP	11–13 mos PP
Demographics	➢ Structured interview	Research Coordinator (RC) administered	√^†	√^†	√^†
Depression Severity	➢ EPDS	RC administered	√	√	√	√	√
Comorbid Anxiety Disorders	➢ GAD-7 ➢ PCL-C	RC administered	√	√	√	√	√
Knowledge, Attitudes, And Treatment Participation	➢ Structured interview assessing mental health treatment initiation and sustainment and barriers and facilitators to treatment participation	Structured interview with RC	√	√	√	√	√
Help-Seeking	➢ BACE ➢ PARC-D	RC administered	√	√	√	√	√
Infant Bonding	➢ S-PBQ	RC administered			√	√	√
Immature Defenses	➢ DSQ-28 (14 Questions)	RC administered			√		√
Obstetric Outcomes	➢ Structured interview assessing obstetric course, birth outcomes (e.g. birth weight, preterm delivery) and infant outcomes	Structured interview with RC			√	√	√

Table 3 represents the time points and frequency at which different patient participant measures are administered according to the PRogram In Support of Moms (PRISM) protocol for the Randomized Controlled Trial (RCT) phase of this study. Measures listed above do not include pre-screen and screening measures done before first time point, including baseline characteristics, MDQ (mood disorder questionnaire), and 4Ps (pregnancy, past, partner, parents) substance abuse screen. Patient participants that are recruited from the holding pool at later gestational ages or postpartum may not complete all measure time points. *Time Points refer to participant’s gestational age (GA) period or postpartum (PP) period in weeks (wks) or months (mos). ^† Demographic questions asked at the time of the initial study phone call with recruitment windows corresponding with the first half of pregnancy, second half of pregnancy, and early postpartum.

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