Health TrialsbyHealthPanel

Pilot Feasibility Study With Doulas

ConditionsPost PartumMaternal DepressionMaternal Depression and Parent Practices, Postpartum
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Edinburgh Postpartum Depression score of 10 or greater;

currently pregnant or within the first 3 years postpartum.

Disqualifiers

high risk of an imminent suicide attempt;

actively psychotic or manic;

current drug or alcohol use disorder;

significant health complications (e.g., cancer).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: You Matter InterventionExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

1

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

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

Time frame
8 weeks
2

Change in Edinburgh Postnatal Depression Scale (EPDS)

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

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: