Perinatal DepressionNCT03420755
Integrating Text Messages Into the Mothers and Babies Course
A study testing Mothers and Babies 1-on-1 and Mothers and Babies Plus Text in people with Perinatal Depression and Postpartum Depression, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, Postpartum Depression
- What is being tested?
- Mothers and Babies 1-on-1 and Mothers and Babies Plus Text
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Perinatal Depression, Postpartum Depression
- Being tested
- Mothers and Babies 1-on-1, Mothers and Babies Plus Text
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothers and Babies 1-on-1Behavioural
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.
Mothers and Babies Plus TextBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Mothers and Babies Plus Text |
What is being measured
The primary outcome is the main question the study is designed to answer.
Text messages read by HV clients
Measured by calculating the percentage of text messages responded to by clients.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Post Intervention at 6 months
Secondary outcomes (6)
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.
Measured: Baseline and Post Intervention at 6 and 9 months
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.
Measured: Baseline and Post Intervention at 6 and 9 months
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.
Measured: Baseline and Post Intervention at 6 and 9 months
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.
Measured: Baseline and Post Intervention at 6 and 9 months
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.
Measured: Baseline and Post Intervention at 6 and 9 months
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.
Measured: Baseline and Post Intervention at 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start7 Jun 2017
- Primary completion28 Feb 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (100)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Darius Tandon, Northwestern University
- Investigators
- Darius Tandon, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420755
- Sponsor's protocol ID
- STU00203918-A
- Other IDs
- 1R21MD011320-01
- Status last verified
- Nov 2019
- First submitted
- 29 Jan 2018
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evans J, Heron J, Francomb H, Oke S, Golding J. Cohort study of depressed mood during pregnancy and after childbirth. BMJ. 2001 Aug 4;323(7307):257-60. doi: 10.1136/bmj.323.7307.257.
PubMed 11485953Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available.
PubMed 15760246Moses-Kolko EL, Roth EK. Antepartum and postpartum depression: healthy mom, healthy baby. J Am Med Womens Assoc (1972). 2004 Summer;59(3):181-91.
PubMed 15354371Segre LS, O'Hara MW, Arndt S, Stuart S. The prevalence of postpartum depression: the relative significance of three social status indices. Soc Psychiatry Psychiatr Epidemiol. 2007 Apr;42(4):316-21. doi: 10.1007/s00127-007-0168-1. Epub 2007 Feb 13.
PubMed 17370048Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006.
PubMed 15234824Beebe B, Jaffe J, Buck K, Chen H, Cohen P, Blatt S, Kaminer T, Feldstein S, Andrews H. Six-week postpartum maternal self-criticism and dependency and 4-month mother-infant self- and interactive contingencies. Dev Psychol. 2007 Nov;43(6):1360-76. doi: 10.1037/0012-1649.43.6.1360.
PubMed 18020817Murray L, Cooper PJ, Wilson A, Romaniuk H. Controlled trial of the short- and long-term effect of psychological treatment of post-partum depression: 2. Impact on the mother-child relationship and child outcome. Br J Psychiatry. 2003 May;182:420-7.
PubMed 12724245National Research Council (US) and Institute of Medicine (US) Committee on the Prevention of Mental Disorders and Substance Abuse Among Children, Youth, and Young Adults: Research Advances and Promising Interventions; O'Connell ME, Boat T, Warner KE, editors. Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32775/
PubMed 20662125Dave S, Sherr L, Senior R, Nazareth I. Associations between paternal depression and behaviour problems in children of 4-6 years. Eur Child Adolesc Psychiatry. 2008 Aug;17(5):306-15. doi: 10.1007/s00787-007-0672-6. Epub 2008 Mar 25.
PubMed 18365134Ramchandani PG, Stein A, O'Connor TG, Heron J, Murray L, Evans J. Depression in men in the postnatal period and later child psychopathology: a population cohort study. J Am Acad Child Adolesc Psychiatry. 2008 Apr;47(4):390-398. doi: 10.1097/CHI.0b013e31816429c2.
PubMed 18388761Fletcher RJ, Feeman E, Garfield C, Vimpani G. The effects of early paternal depression on children's development. Med J Aust. 2011 Dec 19;195(11-12):685-9. doi: 10.5694/mja11.10192.
PubMed 22171866Davis RN, Davis MM, Freed GL, Clark SJ. Fathers' depression related to positive and negative parenting behaviors with 1-year-old children. Pediatrics. 2011 Apr;127(4):612-8. doi: 10.1542/peds.2010-1779. Epub 2011 Mar 14.
PubMed 21402627Tandon SD, Perry DF, Mendelson T, Kemp K, Leis JA. Preventing perinatal depression in low-income home visiting clients: a randomized controlled trial. J Consult Clin Psychol. 2011 Oct;79(5):707-12. doi: 10.1037/a0024895.
PubMed 21806298Tandon SD, Leis JA, Mendelson T, Perry DF, Kemp K. Six-month outcomes from a randomized controlled trial to prevent perinatal depression in low-income home visiting clients. Matern Child Health J. 2014 May;18(4):873-81. doi: 10.1007/s10995-013-1313-y.
PubMed 23793487Mendelson T, Leis JA, Perry DF, Stuart EA, Tandon SD. Impact of a preventive intervention for perinatal depression on mood regulation, social support, and coping. Arch Womens Ment Health. 2013 Jun;16(3):211-8. doi: 10.1007/s00737-013-0332-4. Epub 2013 Mar 2.
PubMed 23456540
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Text Messages Into the Mothers and Babies Course to Address Depression in Low-Income Women and Their Partners
- ClinicalTrials.gov ID
- NCT03420755
- Acronym / sponsor ID
- STU00203918-A
- Conditions
- Perinatal Depression, Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MB 1-on-1 Only | Experimental | Behavioral: Mothers and Babies 1-on-1Mothers 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). |
| MB 1-on-1 Plus TEXT | Experimental | Behavioral: Mothers and Babies Plus TextMothers and Babies Plus Text. MB 1-on-1 along with text enhancements both in English and Spanish. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mothers and Babies 1-on-1MB 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. | Behavioural | MB 1-on-1 Only |
| Mothers and Babies Plus TextMB 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. | Behavioural | MB 1-on-1 Plus TEXT |
Primary outcome
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.
6 secondary outcomes
Depressive Symptoms
Time frame: Baseline and Post Intervention at 6 and 9 months
Cognitive Structuring
Time frame: Baseline and Post Intervention at 6 and 9 months
Behavioral Activation
Time frame: Baseline and Post Intervention at 6 and 9 months
Social Support
Time frame: Baseline and Post Intervention at 6 and 9 months
Mood regulation
Time frame: Baseline and Post Intervention at 6 and 9 months
Mothers and Babies Skill Utilization
Time frame: Baseline and Post Intervention at 6 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Background: PubMed 11485953Evans J, Heron J, Francomb H, Oke S, Golding J. Cohort study of depressed mood during pregnancy and after childbirth. BMJ. 2001 Aug 4;323(7307):257-60. doi: 10.1136/bmj.323.7307.257.
- Background: PubMed 15760246Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available.
- Background: PubMed 15354371Moses-Kolko EL, Roth EK. Antepartum and postpartum depression: healthy mom, healthy baby. J Am Med Womens Assoc (1972). 2004 Summer;59(3):181-91.
- Background: PubMed 17370048Segre LS, O'Hara MW, Arndt S, Stuart S. The prevalence of postpartum depression: the relative significance of three social status indices. Soc Psychiatry Psychiatr Epidemiol. 2007 Apr;42(4):316-21. doi: 10.1007/s00127-007-0168-1. Epub 2007 Feb 13.
- Background: PubMed 15234824Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006.
- Background: PubMed 18020817Beebe B, Jaffe J, Buck K, Chen H, Cohen P, Blatt S, Kaminer T, Feldstein S, Andrews H. Six-week postpartum maternal self-criticism and dependency and 4-month mother-infant self- and interactive contingencies. Dev Psychol. 2007 Nov;43(6):1360-76. doi: 10.1037/0012-1649.43.6.1360.
- Background: PubMed 12724245Murray L, Cooper PJ, Wilson A, Romaniuk H. Controlled trial of the short- and long-term effect of psychological treatment of post-partum depression: 2. Impact on the mother-child relationship and child outcome. Br J Psychiatry. 2003 May;182:420-7.
- Background: PubMed 20662125National Research Council (US) and Institute of Medicine (US) Committee on the Prevention of Mental Disorders and Substance Abuse Among Children, Youth, and Young Adults: Research Advances and Promising Interventions; O'Connell ME, Boat T, Warner KE, editors. Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32775/
- Background: PubMed 18365134Dave S, Sherr L, Senior R, Nazareth I. Associations between paternal depression and behaviour problems in children of 4-6 years. Eur Child Adolesc Psychiatry. 2008 Aug;17(5):306-15. doi: 10.1007/s00787-007-0672-6. Epub 2008 Mar 25.
- Background: PubMed 18388761Ramchandani PG, Stein A, O'Connor TG, Heron J, Murray L, Evans J. Depression in men in the postnatal period and later child psychopathology: a population cohort study. J Am Acad Child Adolesc Psychiatry. 2008 Apr;47(4):390-398. doi: 10.1097/CHI.0b013e31816429c2.
- Background: PubMed 22171866Fletcher RJ, Feeman E, Garfield C, Vimpani G. The effects of early paternal depression on children's development. Med J Aust. 2011 Dec 19;195(11-12):685-9. doi: 10.5694/mja11.10192.
- Background: PubMed 21402627Davis RN, Davis MM, Freed GL, Clark SJ. Fathers' depression related to positive and negative parenting behaviors with 1-year-old children. Pediatrics. 2011 Apr;127(4):612-8. doi: 10.1542/peds.2010-1779. Epub 2011 Mar 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darius Tandon, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mothers and Babies 1-on-1 and Mothers and Babies Plus Text in people with Perinatal Depression and Postpartum Depression, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Text messages read by HV clients (time frame: Post Intervention at 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420755, which also lists 100 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.