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Pilot Feasibility Study With Doulas

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07614789
Enrollment
40
Registered
2026-05-29
Start date
2026-10-01
Completion date
2027-12-01
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Depression, Maternal Depression and Parent Practices, Postpartum, Post Partum

Keywords

Post Partum, maternal depression

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALYouMatter

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

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

are: 1. Edinburgh Postpartum Depression score of 10 or greater; 2. currently pregnant or within the first 3 years postpartum.

Exclusion criteria

includes: 1. high risk of an imminent suicide attempt; 2. actively psychotic or manic; 3. current drug or alcohol use disorder; 4. significant health complications (e.g., cancer).

Design outcomes

Primary

MeasureTime frameDescription
You Matter Intervention Fidelity8 weeksThe 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

MeasureTime frameDescription
Change in PTSD Checklist for DSM-5 (PCL-5)8 weeksA 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
Change in Edinburgh Postnatal Depression Scale (EPDS)8 weeksA 10-item questionnaire on a 4-point Likert scale. Lower score indicates better outcome; Min score: 0; Max score: 30

Countries

United States

Contacts

CONTACTLiz Conradt, Ph.D.
liz.conradt@duke.edu9196812521

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026