Trial Outcomes & Findings for Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression (NCT NCT02979444)

Last Updated: 2020-10-05

Results Overview

Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16). The QIDS-SR16 was used to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual symptom criteria. Total scores range from 0-27; higher scores indicate greater symptomatology. The investigators anticipate a clinically meaningfully difference to be on the order of five points (as this is the difference in score on each severity level of depression) (Trivedi et al., 2004). For our non-inferiority analyses comparing MB led by home visitors vs. MB led by mental health clinicians, we will have \>85% power to detect a difference difference in mean QIDS-16 scores of two points between the two active intervention arms.

Recruitment status

COMPLETED

Study phase

Target enrollment

874 participants

Primary outcome timeframe

Baseline and 12 and 24-week postpartum follow-up

Results posted on

2020-10-05

Participant Flow

All enrolled participants were randomized to one of the three study arms

Participant milestones

Participant milestones
Measure	Mothers and Babies Groups Home-Visitor Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Mothers and Babies Groups Clinician Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Control Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum. These women will receive usual home visiting services.
Overall Study STARTED	405	310	159
Overall Study COMPLETED	382	293	149
Overall Study NOT COMPLETED	23	17	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mothers and Babies Groups Home-Visitor n=405 Participants Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Mothers and Babies Groups Clinician n=310 Participants Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Control n=159 Participants Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.	Total n=874 Participants Total of all reporting groups
Age, Continuous	26.42 Years STANDARD_DEVIATION 5.82 • n=5 Participants	25.80 Years STANDARD_DEVIATION 6.01 • n=7 Participants	25.81 Years STANDARD_DEVIATION 5.39 • n=5 Participants	26.09 Years STANDARD_DEVIATION 5.81 • n=4 Participants
Sex: Female, Male Female	405 Participants n=5 Participants	310 Participants n=7 Participants	159 Participants n=5 Participants	874 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African American	229 Participants n=5 Participants	129 Participants n=7 Participants	24 Participants n=5 Participants	382 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	76 Participants n=5 Participants	82 Participants n=7 Participants	99 Participants n=5 Participants	257 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Latina	63 Participants n=5 Participants	79 Participants n=7 Participants	24 Participants n=5 Participants	166 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian American	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native American	5 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Biracial	19 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	33 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Unknown	11 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	21 Participants n=4 Participants
Region of Enrollment United States	405 participants n=5 Participants	310 participants n=7 Participants	159 participants n=5 Participants	874 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 12 and 24-week postpartum follow-up

Population: These numbers reflect the number of study participants with complete data at our 24-week postpartum assessment.

Outcome measures

Outcome measures
Measure	Mothers and Babies Groups Home-Visitor n=365 Participants Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Mothers and Babies Groups Clinician n=272 Participants Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Control n=146 Participants Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.
The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum 24-Week Postpartum Time Point	5.9 score on a scale Standard Deviation 4.5	5.3 score on a scale Standard Deviation 4.5	5.8 score on a scale Standard Deviation 4.6
The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum 12- Week Postpartum Time Point	6.4 score on a scale Standard Deviation 4.5	5.5 score on a scale Standard Deviation 4.5	5.9 score on a scale Standard Deviation 4.1
The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum Baseline	8.6 score on a scale Standard Deviation 4.3	7.8 score on a scale Standard Deviation 4.3	6.7 score on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: Baseline and 12 and 24-week postpartum follow-ups

Population: Overall number of participants analyzed at 24-weeks postpartum

Behavioral Activation will be measured using the Behavioral Activation Depression Scale (BADS). The BADS assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategies. It examines changes in the following areas: activation, avoidance/ rumination, work/school impairment, and social impairment. The BADS consists of 25 items, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). The range of the scale is 0-64. For the total scale, higher scores represent increased activation. The BADS has demonstrated strong internal consistency, construct validity, and predictive validity (Kanter et al, 2007; Kanter et al., 2009).

Outcome measures

Outcome measures
Measure	Mothers and Babies Groups Home-Visitor n=365 Participants Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Mothers and Babies Groups Clinician n=272 Participants Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Control n=146 Participants Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.
The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum 24-Week Postpartum Time Point	3.6 score on a scale Standard Deviation 1.1	3.8 score on a scale Standard Deviation 1.1	4.0 score on a scale Standard Deviation 1.1
The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum 12- Week Postpartum Time Point	3.6 score on a scale Standard Deviation 1.1	3.8 score on a scale Standard Deviation 1.1	4.1 score on a scale Standard Deviation 1.1
The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum Baseline	3.6 score on a scale Standard Deviation 1.1	3.8 score on a scale Standard Deviation 1.1	4.1 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline and 12 and 24-week postpartum follow-ups

Population: Participants analyzed at 24-weeks postpartum

Mood regulation will be measured using the 30-item Negative Mood Regulation Scale (NMRS) (Catanzaro \& Means, 1990). For each question, respondents use a 5-point scale to indicate what they believe they can do when they are disappointed or experiencing a negative mood. For our analyses, these items were averaged to create a mean NMRS score (range 1-5). Higher scores indicate a greater ability to regulate one's mood.

Outcome measures

Outcome measures
Measure	Mothers and Babies Groups Home-Visitor n=365 Participants Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Mothers and Babies Groups Clinician n=272 Participants Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Control n=146 Participants Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.
The Change in the Negative Mood Regulation Scale 24-Week Postpartum Time Point	3.7 score on a scale Standard Deviation 0.6	3.8 score on a scale Standard Deviation 0.6	3.8 score on a scale Standard Deviation 0.7
The Change in the Negative Mood Regulation Scale 12- Week Postpartum Time Point	3.7 score on a scale Standard Deviation 0.6	3.8 score on a scale Standard Deviation 0.6	3.9 score on a scale Standard Deviation 0.6
The Change in the Negative Mood Regulation Scale Baseline	3.6 score on a scale Standard Deviation 0.6	3.7 score on a scale Standard Deviation 0.6	3.9 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline and 12 and 24-week follow-ups

Population: Participants analyzed at the 24-week postpartum time point

Social support will be measured using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne \& Stewart, 1991). This brief self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction. The range is 1-5 with greater scores indicating more perceived social support.

Outcome measures

Outcome measures
Measure	Mothers and Babies Groups Home-Visitor n=365 Participants Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Mothers and Babies Groups Clinician n=272 Participants Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Control n=146 Participants Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.
The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum 24-Week Postpartum Time Point	3.8 score on a scale Standard Deviation 1.2	3.8 score on a scale Standard Deviation 1.1	4.1 score on a scale Standard Deviation 1.0
The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum 12- Week Postpartum Time Point	3.8 score on a scale Standard Deviation 1.1	3.9 score on a scale Standard Deviation 1.2	4.2 score on a scale Standard Deviation 1.0
The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum Baseline	3.6 score on a scale Standard Deviation 1.2	3.7 score on a scale Standard Deviation 1.2	4.2 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline and 12 and 24-week follow-ups

Population: Participants analyzed at 24-weeks postpartum

Decentering will be measured using the Experiences Questionnaire (EQ) (Fresco et al., 2007). The EQ is a 20 item self-report scale designed to measure decentering and rumination, which has demonstrated strong internal consistency in a number of studies examining effects of interventions that incorporate cognitive restructuring techniques. Response choices are on a 1-5 scale. For the purposes of our analyses, we created a mean EQ score (range 1-5), with higher scores indicating more decentering/rumination.

Outcome measures

Outcome measures
Measure	Mothers and Babies Groups Home-Visitor n=365 Participants Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Mothers and Babies Groups Clinician n=272 Participants Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Mothers and Babies Groups: 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.	Control n=146 Participants Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.
The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum 24-Week Postpartum Time Point	3.4 score on a scale Standard Deviation 0.8	3.5 score on a scale Standard Deviation 0.7	3.5 score on a scale Standard Deviation 0.7
The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum 12- Week Postpartum Time Point	3.4 score on a scale Standard Deviation 0.7	3.4 score on a scale Standard Deviation 0.8	3.5 score on a scale Standard Deviation 0.6
The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum Baseline	3.4 score on a scale Standard Deviation 0.7	3.4 score on a scale Standard Deviation 0.7	3.5 score on a scale Standard Deviation 0.6

Adverse Events

Mothers and Babies Groups Home-Visitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mothers and Babies Groups Clinician

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Darius Tandon, PhD

Northwestern University Feinberg School of Medicine

Phone: 410-852-0399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place