An interventional study of Mothers and Babies Online (eMB) in Perinatal Depression, sponsored by Northwestern University. Completed at 6 sites in United States. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
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.
This pilot study examining how to incorporate Mothers and Babies Online or "eMB" into home visiting program workflows will have three Specific Aims:
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 42 is below the median of 84 across 6,720 interventional studies indexed under Depression.
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Inclusion Criteria:
eMB 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.
Behavioral: Mothers and Babies Online (eMB)
Core 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).
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.
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
Time frame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
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."
Time frame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
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.
Time frame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
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).
Time frame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
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.
Time frame: T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention)
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Northwestern University