Health TrialsbyHealthPanel

Preventing Postpartum Depression in Immigrant Latinas

ConditionPostpartum Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16+
SponsorNorthwestern University

About this trial

Postpartum depression (PPD) affects 10-20% of women, with immigrant Latinas disproportionately affected. PPD prevention and treatment is limited among immigrant Latinas due to an array of structural and cultural factors, suggesting the need to deliver interventions outside of traditional healthcare settings. Virtual interventions have the potential to reduce barriers to mental health services for immigrant Latinas, but there is little research on the effectiveness of virtual interventions to reduce PPD symptoms. Mothers and Babies is an evidence-based group intervention based on principles of cognitive-behavioral therapy and attachment theory aimed at PPD prevention. Mothers and Babies was adapted for delivery via a virtual group format (Mothers and Babies Virtual Group; MB-VG), with a pilot study suggesting good feasibility and acceptability as well as improved mental health outcomes for immigrant Latinas. The proposed project is a Type 1 Effectiveness-Implementation randomized controlled trial among pregnant individuals and new mothers at risk for PPD based on elevated depressive symptoms and/or other established risk factors who are enrolled in early childhood programs across Maryland. A total of 300 women will be enrolled; 150 will receive MB-VG while 150 will receive usual family support services. The project aims to evaluate: 1) the effectiveness of MB-VG to reduce depressive symptoms, prevent onset of PPD, and improve parenting self-efficacy and responsiveness; 2) implementation of MB-VG; and 3) contextual factors influencing MB-VG effectiveness and implementation. Trained early childhood center staff will deliver MB-VG sessions, with intervention participants receiving virtual group sessions via Zoom using any electronic device (smartphone, tablet, laptop). Maternal self-report surveys are conducted at baseline, 1 week, 3 months, and 6 months post-intervention, with structured clinical interviews also conducted at 3- and 6-months post-intervention. The study is the first to deliver a virtual PPD preventive intervention to immigrant Latinas and to evaluate its impact. Given its virtual delivery modality, MB-VG can be easily replicated and scaled to other family support programs and settings serving immigrant Latinas. If effective and implemented broadly, more immigrant Latinas will receive mental health services and fewer will suffer the negative consequences associated with PPD.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Self-identify as Latina

Speak Spanish

Be at least 16 years old

Be pregnant or have a child <9 months

Disqualifiers

Individuals who score >14 on the EPDS are exhibiting moderately severe to severe depressive symptoms and will be excluded given our prevention focus.

Individuals not at risk for PPD-i.e., EPDS scores <5 and under the PDPI-R cutoff-will also be excluded.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mothers and Babies Virtual Group Intervention

    Behavioral

    The Mothers and Babies Virtual Group (MBVG) intervention is a 10-session intervention built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation. Sessions are delivered virtually and are led by a trained MBVG facilitator.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Mothers and Babies Virtual Group InterventionExperimental treatment 1 intervention
Group B: Usual Family Support ServicesNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Depressive symptoms

Depressive symptoms will be measured using the Center for Epidemiologic Studies-Depression (CES-D) scale. The CES-D consists of 20 questions that map onto DSM criteria for depression, with higher scores indicating greater depressive symptoms. The range for the CES-D is 0-60.

Time frame
We are examining change in depressive symptoms from baseline to 6-months post-intervention
2

Depressive episodes

Depressive episodes will be measured using the Mood Disorders module of the Structured Clinical Interview for DSM-V (SCID-5), a semi-structured interview for DSM-V Axis 1 diagnoses. The presence of a depressive episode is ascertained by scoring responses to the SCID questions, with major depression diagnosis ascribed to individuals who endorse: (a) 5 or more depressive symptoms for ≥ 2 weeks, (b) Must have either depressed mood or loss of interest/pleasure, (c) Symptoms must cause significant distress or impairment, and (d) No manic or hypomanic behavior.

Time frame
We are examining new cases of depressive episodes at 3- and 6-months post-intervention
3

Parenting self-efficacy

Parenting self-efficacy will be measured using the self-efficacy subscale of the Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS). The subscale has 7 items, with higher scores indicating greater parental self-efficacy. Calculate the mean score for each subscale. Scores range from 0-10.

Time frame
We will examine parenting self-efficacy at 3- and 6-months post-intervention
4

Parenting responsiveness

Parenting responsiveness will be measured using the parental responsiveness subscale of the Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS). The subscale has 7 items, with higher scores indicating greater parental responsiveness. Calculate the mean score for each subscale. Scores range from 0-10.

Time frame
We will examine parenting responsiveness at 3- and 6-months post-intervention

Secondary outcomes

1

Behavioral activation

Behavioral activation will be measured using the Behavioral Activation Depression Scale (BADS), a 25-item scale that assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategy. The BADS has a range from 0-54, with higher scores on the BADS indicate greater behavioral activation.

Time frame
We will examine change in behavioral activation between baseline and 6-month post-intervention follow-up
2

Decentering

Decentering will be measured using the Experiences Questionnaire (EQ), a 20-item self-report scale designed to measure decentering and rumination. The EQ has a range from 0-11, with higher scores on the EQ indicate greater decentering.

Time frame
We will examine change in decentering between baseline and 6-month post-intervention follow-up
3

Social support

Social support will be measured using the 12-item Multidimensional Scale of Perceived Social Support. This scale has a range from 12-84, with higher scores indicate greater social support.

Time frame
We will examine change in social support between baseline and 6-month post-intervention follow-up
4

Mood management

Mood management will be measured using the 8-item PROMIS Self-Efficacy Managing Emotions Questionnaire. This scale ranges from 8-40, with higher scores indicating greater mood management

Time frame
We will examine change in mood management between baseline and 6-month post-intervention follow-up

Other outcomes

Sponsors and contacts

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Northwestern University

Lead sponsor

Johns Hopkins University

Collaborator

Palo Alto University

Collaborator

Source ClinicalTrials.gov
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