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NCT Number: NCT07614789

Pilot Feasibility Study With Doulas

The purpose of this study is to determine whether an existing evidence-based intervention, You Matter, can be delivered with fidelity by doulas at their community clinic, MAAME, Inc.

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Key information

Conditions

Post Partum Maternal Depression Maternal Depression and Parent Practices, Postpartum

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The purpose of this study is to determine whether an existing evidence-based intervention, You Matter, can be delivered with fidelity by doulas at their community clinic, MAAME, Inc. The researchers will: (1) train doulas to implement You Matter; (2) recruit 40 pregnant and postpartum women to participate in You Matter; (3) evaluate whether You Matter reduced postpartum depression and trauma symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

are:

  • Edinburgh Postpartum Depression score of 10 or greater;
  • currently pregnant or within the first 3 years postpartum.

Exclusion criteria

includes:

  • high risk of an imminent suicide attempt;
  • actively psychotic or manic;
  • current drug or alcohol use disorder;
  • significant health complications (e.g., cancer).

Treatment and study plan

YouMatter

Behavioral

You Matter is an 8-week, 8-session (8 group sessions) intervention that integrates mental health and parenting psychoeducation, supports parent-child interactions, enhances social connections, provides access to culturally-relevant resources, and emphasizes emotional and physical self-care

Primary outcomes

  1. You Matter Intervention Fidelity

    Time frame: 8 weeks

    The percentage of content of the You Matter Intervention that were accurately delivered (yes/no) across providers as determined by rater's assessment of recorded sessions.

Secondary outcomes

  1. Change in PTSD Checklist for DSM-5 (PCL-5)

    Time frame: 8 weeks

    A 20 item questionnaire with a 5 point Likert -scale ranging from not at all to extremely. Lower scores indicate better outcomes; Min score: 0; Max score: 80

  2. Change in Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: 8 weeks

    A 10-item questionnaire on a 4-point Likert scale. Lower score indicates better outcome; Min score: 0; Max score: 30

Study contacts

Contact information is provided by the study sponsor or research team.

Liz Conradt, Ph.D.

CONTACT

[email protected]

9196812521

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

A Pilot Feasibility Study to Evaluate a Doula-led Postpartum Prevention Intervention

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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