CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 874 enrolled
Drug / intervention
Mothers and Babies Groupsbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02979444
NCT02979444N/ACompleted

Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression

Northwestern University·interventional·Posted Dec 1, 2016·Updated Oct 5, 2020

In Brief

A clinical study evaluating Mothers and Babies Groups for Perinatal Depression and PostPartum Depression. Completed, enrolled 874 participants across 1 site.

Detailed Summary

There is considerable evidence that most perinatal women at risk for postpartum depression do not engage in mental health services, even when referred by home visiting (HV) programs, primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be delivered via alternative settings-e.g., HV programs-are essential to prevent the onset of major depression and worsening of depressive symptoms among perinatal women. This Patient Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care (i.e., home visiting without the MB enhancement). It will also examine if MB, when led by paraprofessional home visitors, is not inferior to MB delivered by mental health professionals. The results of this study will inform decision-making by HV programs regarding provision of MB to perinatal women at risk for developing major depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 1, 2016
Enrollment StartAug 1, 2016
Primary CompletionAug 5, 2019
Study CompletionAug 13, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.6 years ago

Interventions

Mothers and Babies Groupsbehavioral

The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a "toolkit" of approaches they can use to improve their mood.