NCT07614789

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

May 22, 2026

Last Update Submit

May 29, 2026

Conditions

Post PartumMaternal Depression and Parent Practices, PostpartumMaternal Depression

Keywords

Post Partummaternal depression

Outcome Measures

Primary Outcomes (1)

  • You Matter Intervention Fidelity

    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.

    8 weeks

Secondary Outcomes (2)

  • Change in PTSD Checklist for DSM-5 (PCL-5)

    8 weeks

  • Change in Edinburgh Postnatal Depression Scale (EPDS)

    8 weeks

Study Arms (1)

You Matter Intervention

EXPERIMENTAL

Receive the YouMatter intervention.

Behavioral: YouMatter

Interventions

YouMatterBEHAVIORAL

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

You Matter Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Central Study Contacts

Liz Conradt, Ph.D.

CONTACT

9196812521liz.conradt@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)