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Perinatal DepressioneMBNCT05714956

Pilot Study of Mothers and Babies Online in Home Visiting

A study testing Mothers and Babies Online (eMB) in people with Perinatal Depression, run by Northwestern University at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators propose a pilot randomized controlled trial (RCT) that examines how the redesigned version of Mothers and Babies Online (eMB) can be delivered in the context of home visiting (HV) programs that serve pregnant individuals and new mothers across the United States. The PI, Dr. Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Perinatal Depression
What is being tested?
Mothers and Babies Online (eMB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
6 sitesUnited States
Study dates
1 Mar 2023to 1 Oct 2024
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
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Are enrolled in home visiting services
  • Are 16 years or older
  • Are English Proficient (reading, speaking, and writing)
  • Are currently pregnant or have a young child up to 6 months
  • Have internet access
  • Have access to an electronic device (cell phone, laptop, tablet, etc.)
  • Are at risk for developing perinatal depression as defined by one or more of the following: a score of 5-14 on the Edinburgh Postnatal Depression Scale (EPDS), a score of >3.5 on the Postpartum Depression Predictors Inventory (PDPI), personal history of depression, and/or familial history of depression.

Who cannot join

None listed.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • South Central Iowa Community Action Program

    Chariton, Iowa, 50049

  • Metropolitan Family Services

    Chicago, Illinois, 60606

  • Carolina Health Centers

    Greenwood, South Carolina, 29646

  • Children & Family Resource Center

    Hendersonville, North Carolina, 28792

  • Easter Seals

    Joliet, Illinois, 60435

  • Newport News

    Newport News, Virginia, 23607

Other trials in United States

About this study

Official title: Understanding the Needs of Parents and Providers With Mothers and Babies Online (eMB): A User Centered Approach

The investigators propose a pilot randomized controlled trial (RCT) that examines how the redesigned version of Mothers and Babies Online (eMB) can be delivered in the context of home visiting (HV) programs that serve pregnant individuals and new mothers across the United States. The PI, Dr. Darius Tandon (Northwestern University), has conducted extensive research on the in-person Mothers and Babies (MB) intervention with HV programs and has received interest from one of the largest HV models-Parents as Teachers (PAT)-to explore the use of eMB with pregnant individuals that they serve.

Read the detailed description

This pilot study examining how to incorporate Mothers and Babies Online or "eMB" into home visiting program workflows will have three Specific Aims:

  1. Employ a user-centered design (UCD) approach in which investigators will conduct semi-structured qualitative interviews with key home visiting stakeholders (n = 10 parent clients, n = 5 home visitors) to generate recommendations on a) how to integrate eMB into home visiting program workflows, b) appropriate strategies for home visitors providing human support to support eMB engagement, c) reactions to the messaging and tone of eMB; and c) potential barriers and facilitators to eMB engagement.
  2. Conduct a small randomized trial that examines the feasibility, acceptability, and effectiveness of eMB when implemented in home visiting programs. Investigators will recruit 50 pregnant individuals and new mothers from 5-8 Parents as Teachers programs that serve rural communities. Investigators have chosen to focus on rural communities given the challenges associated with in-person intervention delivery in those settings. These individuals will be randomized where 40 individuals will complete the eMB intervention and 10 will serve as controls receiving usual HV services. Participants who are at-risk for developing postpartum depression will be eligible for the study. Investigators will assess risk for postpartum depression using two screening tools-the Edinburgh Postnatal Depression Scale (EPDS) and the Postpartum Depression Predictors Inventory (PDPI). Women scoring in the mild/moderate range (5-14) on the EPDS or scoring >3.5 on the PDPI are considered at elevated risk for postpartum depression. Data from the UCD phase will be used to develop study protocols for implementing eMB, including how home visitors providing human support/coaching while clients are engaged with eMB. Investigators will collect maternal self-report data on depressive symptoms, perceived stress, and other mental health outcomes at baseline (pre-intervention), 1-week post-intervention, and 3-months post-intervention.
  3. Conduct brief semi-structured interviews with n = 15 parent clients who received eMB during the pilot RCT and n = 5 home visitors who provided eMB coaching during the pilot RCT to understand user experience with eMB (with particular emphasis on understanding any human support/coaching component), which will guide any necessary modifications to the intervention protocol. Investigators will also conduct brief semi-structured interviews with program managers from participating Parents as Teachers (PAT) programs and PAT leadership to assess organizational-level barriers and facilitators to eMB uptake, which will inform future research directions related to the implementation of eMB.
Being tested
Mothers and Babies Online (eMB)
Keywords
eHealth, Home Visiting, perinatal, depression, perinatal depression, user centered design, digital mental health
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mothers and Babies Online (eMB)Behavioural

    This study's intervention is called Mothers and Babies Online or "eMB", which consists of 8 sessions that correspond with key cognitive-behavioral therapy (CBT) elements: pleasant activities, thoughts, and social support/contact with others. Integrated throughout eMB are activities and skills based on attachment theory that emphasize how each CBT module relates to promoting a strong, nurturing connection between parent and child. eMB includes informational pages, short audio/video clips, images of infants and pregnant women, and worksheets for participants to enter personalized information in response to the lesson content. eMB is individually guided without facilitation, b) clients control the pace by which they review online content, c) and clients can review online content as many times as they like. Participants who receive eMB will also complete assessments at baseline, 1 week post-intervention, and 3 months post-intervention.

Study groups in NCT05714956
Study groupRoleWhat they receive
InterventionExperimentaleMB consists of 8 sessions that correspond with key cognitive-behavioral therapy (CBT) elements: pleasant activities, thoughts, and social support/contact with others. Integrated throughout eMB are activities and skills based on attachment theory that emphasize how each CBT module relates to promoting a strong, nurturing connection between parent and child. eMB includes informational pages, short audio/video clips, images of infants and pregnant women, and worksheets for participants to enter personalized information in response to the lesson content. eMB is individually guided without facilitation, b) clients control the pace by which they review online content, c) and clients can review online content as many times as they like. Participants who receive eMB will also complete assessments at baseline, 1 week post-intervention, and 3 months post-intervention.
Receives: Behavioral: Mothers and Babies Online (eMB)
Home Visiting Usual CareNo interventionCore content of home visiting program services typically address: (a) preparation for childbirth and having a young child in the home, (b) provision of emotional and tangible [e.g., diapers, formula] support, (c) discussion of infant and young child development, (d) linkages to prenatal and pediatric care, and (e) referrals to community resources for social and health services. Those receiving usual care home visiting will not receive any eMB or MB course content. Once study participation is completed, the home visitor may introduce eMB to the participant if they are interested. Participants in the control group will also complete assessments at baseline, 1 week post-intervention (i.e., following 8 weeks of usual home visiting services), and 3 months post-intervention (i.e.g, following 8 weeks of usual home visiting services).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in depressive symptoms

    Depression will be assessed using the Center for Epidemiological Studies-Depression Scale, which is a 20-item measure that asks participants to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Scores range from 0-60 with higher scores indicating greater depressive symptomatology

    Measured: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)

Secondary outcomes (4)

  1. Change in perceived stress

    Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), which asks respondents to indicate their levels of perceived stress in the last month, with a response of "0" indicating "Never" and a response of "4" indicating "very often."

    Measured: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)

  2. Change in anxiety symptoms

    Symptoms of anxiety will be measured using the Generalized Anxiety Disorder-7, which is a 7-item measure that aligns with the Diagnostic and Statistical manual of Mental Disorders (DSM-5) criteria for GAD and assesses anxiety symptom frequency and severity. This instrument has scores ranging from 0-21 with higher scores indicating greater anxiety symptoms.

    Measured: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)

  3. Change in parenting sense of competence

    Parenting sense of competence (PSOC) is a 17-item scale developed to assess parenting self-esteem. The scale includes two rationally derived scales, Skill-Knowledge and Value-Comforting, referred to as Efficacy and Satisfaction. Each item is answered on a 6-point scale ranging from strongly disagree (6) to strongly agree (1).

    Measured: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)

  4. Chang in dimensions of couple relationships

    Dimensions of couple relationships will be measured using the Revised Dyadic Adjustment Scale , a report questionnaire that assesses seven dimensions of couple relationships within three overarching categories including consensus in decision making, values and affection, satisfaction in the relationship with respect to stability and conflict regulation, and cohesion. Scores range from 0-69 with higher scores indicating stronger relationships.

    Measured: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2023
  2. Study start1 Mar 2023
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05714956
Sponsor's protocol ID
STU00216763
Other IDs
5P50MH119029-03
Acronym
eMB
Status last verified
Dec 2024
First submitted
25 Jan 2023
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
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 11485953

  • Gaynes 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 15760246

  • Moses-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 15354371

  • Segre 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 17370048

  • Robertson 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 15234824

  • Beebe 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 18020817

  • Murray 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 12724245

  • National 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 20662125

  • American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders: DSM-5. ManMag; 2003.

  • Howell EA, Mora PA, Horowitz CR, Leventhal H. Racial and ethnic differences in factors associated with early postpartum depressive symptoms. Obstet Gynecol. 2005 Jun;105(6):1442-50. doi: 10.1097/01.AOG.0000164050.34126.37.

    PubMed 15932842

  • Mora PA, Bennett IM, Elo IT, Mathew L, Coyne JC, Culhane JF. Distinct trajectories of perinatal depressive symptomatology: evidence from growth mixture modeling. Am J Epidemiol. 2009 Jan 1;169(1):24-32. doi: 10.1093/aje/kwn283. Epub 2008 Nov 10.

    PubMed 19001135

  • Bennett HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004 Apr;103(4):698-709. doi: 10.1097/01.AOG.0000116689.75396.5f.

    PubMed 15051562

  • Dolbier CL, Rush TE, Sahadeo LS, Shaffer ML, Thorp J; Community Child Health Network Investigators. Relationships of race and socioeconomic status to postpartum depressive symptoms in rural African American and non-Hispanic white women. Matern Child Health J. 2013 Sep;17(7):1277-87. doi: 10.1007/s10995-012-1123-7.

    PubMed 22961387

  • Holzman C, Eyster J, Tiedje LB, Roman LA, Seagull E, Rahbar MH. A life course perspective on depressive symptoms in mid-pregnancy. Matern Child Health J. 2006 Mar;10(2):127-38. doi: 10.1007/s10995-005-0044-0. Epub 2006 Jan 7.

    PubMed 16400535

  • Schmit S, Schott L, Pavetti L, Matthews H. Effective, Evidence-Based Home Visiting Programs in Every State at Risk if Congress Does Not Extend Funding. 2015;http://www.cbpp.org/research/effective-evidence-based-home-visiting-programs-in-every-state-at-risk-if-congress-does-not. Accessed February 10, 2016.

Questions about this trial

What is this clinical trial studying?

A study testing Mothers and Babies Online (eMB) in people with Perinatal Depression, run by Northwestern University at 6 sites 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 7 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

Change in depressive symptoms (time frame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)). 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 NCT05714956, which also lists 38 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 13 Dec 2024.

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eMB Clinical Trial NCT05714956 | AzTrials