Integrating Text Messages Into the Mothers and Babies Course
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|ClinicalTrials.gov Identifier: NCT03420755|
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Depression Postpartum Depression||Behavioral: Mothers and Babies 1-on-1 Behavioral: Mothers and Babies Plus Text||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Factorial Assignment|
|Intervention 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)|
|Official Title:||Integrating Text Messages Into the Mothers and Babies Course to Address Depression in Low-Income Women and Their Partners|
|Actual Study Start Date :||June 7, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: MB 1-on-1 Only
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).
Behavioral: Mothers and Babies 1-on-1
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.
Experimental: MB 1-on-1 Plus TEXT
Mothers and Babies Plus Text. MB 1-on-1 along with text enhancements both in English and Spanish.
Behavioral: Mothers and Babies Plus Text
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.
- Text messages read by HV clients [ Time Frame: Post Intervention at 6 months ]Measured by calculating the percentage of text messages responded to by clients.
- Home Visitor Adherence to MB-TXT protocol [ Time Frame: Post Intervention at 6 months ]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 [ Time Frame: Post Intervention at 6 months ]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 [ Time Frame: Post Intervention at 6 months ]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.
- Depressive Symptoms [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]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 [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]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 [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]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 [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]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 [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]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 [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]will be assessed using items developed the study investigators to assess participants utilization of the skills learned in the 12 MB sessions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420755
|Contact: Jaime Hamil, MPHemail@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Jaime Hamil, MPH 312-503-2645 firstname.lastname@example.org|
|Principal Investigator: Darius Tandon, PhD|
|Principal Investigator:||Darius Tandon, PhD||Northwestern University|