Pilot Feasibility Study With Doulas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: YouMatter.
- Who it may be relevant to
- Registry conditions: Post Partum, Maternal Depression, Maternal Depression and Parent Practices, Postpartum. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Feasibility Study to Evaluate a Doula-led Postpartum Prevention Intervention
Overview
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
- Behavioral YouMatter
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 outcome measures
- You Matter Intervention Fidelity [Time frame: 8 weeks]
Secondary outcome measures (2)
- Change in PTSD Checklist for DSM-5 (PCL-5) [Time frame: 8 weeks]
- Change in Edinburgh Postnatal Depression Scale (EPDS) [Time frame: 8 weeks]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT07614789 · Pro00119143