Integrating Text Messages Into the Mothers and Babies Course



Status:Recruiting
Conditions:Depression, Depression, Women's Studies
Therapuetic Areas:Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:16 - Any
Updated:2/10/2018
Start Date:June 7, 2017
End Date:December 2018
Contact:Jaime Hamil, MPH
Email:jaime.hamil@northwestern.edu
Phone:312-503-2645

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Integrating Text Messages Into the Mothers and Babies Course to Address Depression in Low-Income Women and Their Partners

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.

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.

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
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Darius Tandon, PhD
Phone: 312-503-2645
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from
Chicago, IL
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