Integrating Text Messages Into the Mothers and Babies Course
Primary Purpose
Perinatal Depression, Postpartum Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mothers and Babies 1-on-1
Mothers and Babies Plus Text
Sponsored by
About this trial
This is an interventional prevention trial for Perinatal Depression
Eligibility Criteria
Inclusion Criteria:
English or Spanish-speaking women >16 years old enrolled in participating home visiting programs who are in their 1st or 2nd or 3rd Trimester will be eligible for enrollment
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MB 1-on-1 Only
MB 1-on-1 Plus TEXT
Arm Description
Mothers and Babies 1-on-1. MB 1-on-1 -12-session intervention Each MB session lasts 15-20 minutes and is delivered as part of a regularly scheduled home visit (English or Spanish).
Mothers and Babies Plus Text. MB 1-on-1 along with text enhancements both in English and Spanish.
Outcomes
Primary Outcome Measures
Text messages read by HV clients
Measured by calculating the percentage of text messages responded to by clients.
Home Visitor Adherence to MB-TXT protocol
will be measured by using the archived data from HealthySMS to calculate the percentage of texts sent at the appropriate intervals
Client completion of personal projects
will be measured by asking home visitors to respond to a REDCap survey item after completing each MB session to assess if clients came to the session having completed their personal project.
Client perceived utility and comprehension of text messages
will be measured by asking home visitors to rate the extent to which each of the 3 text messages received between sessions was a) useful and b) easy to understand. Questions will be on a 4-point Likert Scale and will be asked of clients at the end of each MB session.
Secondary Outcome Measures
Depressive Symptoms
will be assessed using the Beck Depression Inventory-II (BDI),100 a 21-item self-report measure of depressive symptoms to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual (DSM)-IV symptom criteria. The BDI has excellent internal reliability for outpatient samples and its construct validity has been established.
Cognitive Structuring
will be measures using the Experiences Questionnaire a 20-item self-report scale measuring decentering and rumination, which has demonstrated strong internal consistency in studies examining effects of interventions that incorporate cognitive restructuring.
Behavioral Activation
will be measured using the Behavioral Activation Depression Scale, a 25-item, four subscale self-report with strong psychometric properties. The four subscales assess activation, avoidance/rumination, work/school impairment, and social impairment. We will also use a brief checklist adapted from the Pleasant Events Schedule, a psychometrically strong questionnaire. This 25 item self-report contains a list of pleasant events relevant to low-income pregnant women and assesses the extent to which subject's engaged in, and experienced pleasure from, these activities.
Social Support
19-item Medical Outcomes Study Social Support Survey. This 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.
Mood regulation
will be measured using the Negative Mood Regulation Scale (NMRS).The NMRS assesses an individual's expectancy that some behavior or cognition will alleviate a negative mood state. For each question, respondents use a five-point scale from "very much disagree" to "very much agree" to indicate what they believe they can do when they are disappointed or experiencing a negative mood. The scale has demonstrated excellent internal consistency, good test-retest reliability, and correlational evidence of both convergent and discriminant validity with constructs such as depressive symptoms and locus of control, respectively.
Mothers and Babies Skill Utilization
will be assessed using items developed the study investigators to assess participants utilization of the skills learned in the 12 MB sessions.
Full Information
NCT ID
NCT03420755
First Posted
January 29, 2018
Last Updated
November 13, 2019
Sponsor
Northwestern University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT03420755
Brief Title
Integrating Text Messages Into the Mothers and Babies Course
Official Title
Integrating Text Messages Into the Mothers and Babies Course to Address Depression in Low-Income Women and Their Partners
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project is aimed at enhancing the effectiveness and scalability of the Mothers and Babies 1-on-1 Course (MB) among home visiting programs. MB is a manualized 12-session postpartum depression prevention intervention guided by cognitive-behavioral therapy and attachment theory. Each session lasts 15-20 minutes and is delivered as part of a regularly scheduled home visit. Previous MB trials suggest that the intervention is less successful for women who exhibit smaller changes in hypothesized intervention mechanisms and less fully engaged in completion of personal projects. This study will determine the feasibility and acceptability of conducting MB-TXT, in which home visiting clients receive MB supplemented by a series of weekly text messages focused on skill reinforcement, personal project reminders, and self-monitoring of depressive symptoms. The investigators will also calculate a preliminary effect size that could be used to calculate sample size necessary for a future fully powered randomized controlled trial that examines MB-TXT efficacy. The investigators will use a stepped wedge design-a form of randomized controlled trial that involves sequential, but random, roll-out of the intervention over multiple time periods. The investigators have created two HV program clusters. Both clusters will initially implement MB 1-on-1 and will recruit MB participants for one quarter (i.e., three months) before crossing over to recruit MB-TXT participants for one quarter. MB-TXT's core curriculum is identical to MB 1-on-1 and adds a series of text messages throughout the curriculum. Feasibility and acceptability data will be collected from clients and home visitors to assess percentages of received text messages, home visitor adherence to sending texts at specified intervals, and clients' perceptions of text message utility and clarity. If the investigators are able to integrate MB-TXT and home visiting programs and generate improved mental health outcomes for clients, the investigators will be prepared to replicate this intervention across home visiting programs nationally at a time when home visiting as a service delivery model is rapidly proliferating via federal Maternal Infant and and Early Childhood Home Visiting (MIECHV) program funding.
Detailed Description
Despite the well-established negative effects of postpartum depression on mother and child, most efforts have been directed at treating women already exhibiting depressive episodes rather than prevention. Emphasis on treatment neglects the large number of women with mild to moderate depressive symptoms, in high psychosocial risk contexts, who are at risk for developing postpartum depression. Interventions exist that are efficacious in preventing the onset and worsening of depression among perinatal women. In particular, the PI and colleagues have demonstrated that the Mothers and Babies Course (MB) prevents the worsening of depressive symptoms and onset of new major depressive episodes.
Prior MB trials suggest the intervention is less successful for women who exhibit smaller changes in hypothesized intervention mechanisms and less fully engage in homework completion between sessions-a core component of cognitive-behavioral therapy (CBT) interventions like MB. Previous postpartum depression preventive interventions-including MB-have neglected to intervene with partners of pregnant women, despite the growing recognition that paternal depression also exerts influence on children's social-emotional development and occurs in a similar time-frame. Thus, in an otherwise successful intervention, these limitations-mixed success in improving hypothesized intervention mechanisms and limited engagement of fathers-may mitigate intervention efficacy. The investigators hypothesize that core MB modules will prevent onset of major depressive episodes and worsening of depressive symptoms. The investigators also conceptualize that relationships between MB modules and maternal mental health outcomes will be mediated by mechanisms that are the direct focus of MB content.
This study addresses these limitations. The investigators will collaborate with 10-12 home visiting (HV) programs serving primarily low-income women. HV is an ideal setting for this study given the large numbers of perinatal women they serve and will build on existing relationships with HV programs in Illinois. In Phase 1, the investigators will recruit 108 pregnant women for a randomized controlled trial (RCT) in which half the participants will receive MB and half will receive MB with a text message enhancement (MB-TXT). MB-TXT will provide reinforcement of key MB skills that are linked to hypothesized mechanisms of change, promote completion of MB personal projects (homework), and facilitate self-monitoring of one's mood.
Aim 1. To determine the feasibility and acceptability of conducting the MB-TXT intervention protocol across three HV programs in preparation for a larger fully powered RCT. Using MB text messages already developed by Co-I Barrera, we will collect data on home visitor adherence to delivering text messages at specified intervals, percentage of clients responding to text messages, and client comprehension of text messages as well as perceptions of text messages' utility.
Aim 2. To calculate a preliminary effect size that could be used, along with other relevant data, to calculate sample size for a future fully powered RCT.
H1. Women receiving MB-TXT will exhibit greater reductions in depressive symptoms, compared to women receiving MB.
H2. Women receiving MB-TXT will experience greater changes in hypothesized intervention mechanisms compared to women receiving MB-specifically, fewer negative cognitions and increased behavioral activation, use of social support networks, and mood regulation.
H3. Women who participate in MB-TXT will report greater completion of personal projects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression, Postpartum Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The investigators will use a stepped wedge design-a form of RCT that involves sequential, but random, rollout of the intervention over multiple time periods. The investigaotrs have created two HV program clusters. Both clusters will initially implement MB 1-on-1 and will recruit MB participants for one quarter (i.e., three months) before crossing over to recruit MB-TXT participants for one quarter. MB-TXT's core curriculum is identical to MB 1-on-1 and adds a series of text messages throughout the curriculum.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MB 1-on-1 Only
Arm Type
Experimental
Arm Description
Mothers and Babies 1-on-1. MB 1-on-1 -12-session intervention Each MB session lasts 15-20 minutes and is delivered as part of a regularly scheduled home visit (English or Spanish).
Arm Title
MB 1-on-1 Plus TEXT
Arm Type
Experimental
Arm Description
Mothers and Babies Plus Text. MB 1-on-1 along with text enhancements both in English and Spanish.
Intervention Type
Behavioral
Intervention Name(s)
Mothers and Babies 1-on-1
Intervention Description
MB 1-on-1 is a 12-session intervention divided into five modules. An introductory 2-session module establishes key concepts related to stress, monitoring of one's mood, and ways in which one's mood influences one's internal thoughts and external environment; three 3-session modules correspond with key cognitive-behavioral elements: pleasant activities, thoughts, and social support/contact with others; a 1-session summary reviews content and identifies areas for future use of MB skills. Throughout MB, mood management skills are integrated using psycho-educational activities that encourage participants to understand connections between their mood and their activities, thoughts, and contacts with others.
Intervention Type
Behavioral
Intervention Name(s)
Mothers and Babies Plus Text
Intervention Description
MB 1-on-1 along with text enhancements, both in English and Spanish. These texts focus on: a) skill reinforcement (e.g., Some thoughts just come to us, but we can make a conscious effort to think of positive thoughts.); b) homework reminders (e.g., What pleasant activity will you try today?), and c) self-monitoring (e.g., On a scale of 1-9, how would you rate your mood?). These texts will be linked with the 12 MB sessions. Specifically, after completing each in-person session, 3 texts will be sent by a home visitor to her client; one text will focus on skill reinforcement, one will be a homework reminder, and one will focus on self-monitoring.
Primary Outcome Measure Information:
Title
Text messages read by HV clients
Description
Measured by calculating the percentage of text messages responded to by clients.
Time Frame
Post Intervention at 6 months
Title
Home Visitor Adherence to MB-TXT protocol
Description
will be measured by using the archived data from HealthySMS to calculate the percentage of texts sent at the appropriate intervals
Time Frame
Post Intervention at 6 months
Title
Client completion of personal projects
Description
will be measured by asking home visitors to respond to a REDCap survey item after completing each MB session to assess if clients came to the session having completed their personal project.
Time Frame
Post Intervention at 6 months
Title
Client perceived utility and comprehension of text messages
Description
will be measured by asking home visitors to rate the extent to which each of the 3 text messages received between sessions was a) useful and b) easy to understand. Questions will be on a 4-point Likert Scale and will be asked of clients at the end of each MB session.
Time Frame
Post Intervention at 6 months
Secondary Outcome Measure Information:
Title
Depressive Symptoms
Description
will be assessed using the Beck Depression Inventory-II (BDI),100 a 21-item self-report measure of depressive symptoms to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual (DSM)-IV symptom criteria. The BDI has excellent internal reliability for outpatient samples and its construct validity has been established.
Time Frame
Baseline and Post Intervention at 6 and 9 months
Title
Cognitive Structuring
Description
will be measures using the Experiences Questionnaire a 20-item self-report scale measuring decentering and rumination, which has demonstrated strong internal consistency in studies examining effects of interventions that incorporate cognitive restructuring.
Time Frame
Baseline and Post Intervention at 6 and 9 months
Title
Behavioral Activation
Description
will be measured using the Behavioral Activation Depression Scale, a 25-item, four subscale self-report with strong psychometric properties. The four subscales assess activation, avoidance/rumination, work/school impairment, and social impairment. We will also use a brief checklist adapted from the Pleasant Events Schedule, a psychometrically strong questionnaire. This 25 item self-report contains a list of pleasant events relevant to low-income pregnant women and assesses the extent to which subject's engaged in, and experienced pleasure from, these activities.
Time Frame
Baseline and Post Intervention at 6 and 9 months
Title
Social Support
Description
19-item Medical Outcomes Study Social Support Survey. This 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.
Time Frame
Baseline and Post Intervention at 6 and 9 months
Title
Mood regulation
Description
will be measured using the Negative Mood Regulation Scale (NMRS).The NMRS assesses an individual's expectancy that some behavior or cognition will alleviate a negative mood state. For each question, respondents use a five-point scale from "very much disagree" to "very much agree" to indicate what they believe they can do when they are disappointed or experiencing a negative mood. The scale has demonstrated excellent internal consistency, good test-retest reliability, and correlational evidence of both convergent and discriminant validity with constructs such as depressive symptoms and locus of control, respectively.
Time Frame
Baseline and Post Intervention at 6 and 9 months
Title
Mothers and Babies Skill Utilization
Description
will be assessed using items developed the study investigators to assess participants utilization of the skills learned in the 12 MB sessions.
Time Frame
Baseline and Post Intervention at 6 and 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
English or Spanish-speaking women >16 years old enrolled in participating home visiting programs who are in their 1st or 2nd or 3rd Trimester will be eligible for enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darius Tandon, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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