Integrating Text Messages Into the Mothers and Babies Course

NCT03420755 | Completed

• 2 other identifiers: STU00203918-A1R21MD011320-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression; Postpartum Depression

Outcome Measures

Primary Outcomes (4)

• Text messages read by HV clients

  Measured by calculating the percentage of text messages responded to by clients.

  Post Intervention at 6 months

• 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

  Post Intervention at 6 months

• 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.

  Post Intervention at 6 months

• 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.

  Post Intervention at 6 months

Secondary Outcomes (6)

• Depressive Symptoms

  Baseline and Post Intervention at 6 and 9 months

• Cognitive Structuring

  Baseline and Post Intervention at 6 and 9 months

• Behavioral Activation

  Baseline and Post Intervention at 6 and 9 months

• Social Support

  Baseline and Post Intervention at 6 and 9 months

• Mood regulation

  Baseline and Post Intervention at 6 and 9 months

Study Arms (2)

MB 1-on-1 Only

EXPERIMENTAL

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 Plus TEXT

EXPERIMENTAL

Mothers and Babies Plus Text. MB 1-on-1 along with text enhancements both in English and Spanish.

Behavioral: Mothers and Babies Plus Text

Interventions

Mothers and Babies 1-on-1 BEHAVIORAL

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.

MB 1-on-1 Only

Mothers and Babies Plus Text BEHAVIORAL

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.

MB 1-on-1 Plus TEXT

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

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  PMID: 34792478 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Darius Tandon, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: June 7, 2017
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)