ACTIVE_NOT_RECRUITING

MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this R34 exploratory research proposal is to conduct formative work for a larger randomized controlled trial (RCT) evaluating the effectiveness of the "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms. The proposed study will enroll pregnant women who report experience of IPV in the past 6 months, and who screen positive for elevated depressive and/or PTSD symptoms. The intervention lasts 6 months after enrollment.

Official Title

MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence: Randomized Trial

Quick Facts

Study Start:2024-10-08
Study Completion:2026-01-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05106361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant and/or are mothers of children under 5 and r
  2. * Report IPV experiences in the past 6 months (as assessed by Composite Abuse Scale)
  3. * Aged 18 or above,
  4. * Have elevated depressive and/or PTSD symptoms as assessed by Patient Health Questionnaire (PHQ-9) with a cutoff point of ≥9, and/or the Davidson Trauma Scale (DTS) with a cut-off point of ≥40.
  1. * Cannot provide the name and contact information of at least two locator persons,
  2. * Do not have access to any telephone,
  3. * Cannot understand English well enough to understand the consent form or assessment instruments when they are read aloud

Contacts and Locations

Study Locations (Sites)

YWCA Flint
Flint, Michigan, 48502
United States

Collaborators and Investigators

Sponsor: Michigan State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-08
Study Completion Date2026-01-20

Study Record Updates

Study Start Date2024-10-08
Study Completion Date2026-01-20

Terms related to this study

Keywords Provided by Researchers

  • Intimate partner violence
  • Women
  • Mothers
  • Pregnant

Additional Relevant MeSH Terms

  • Intimate Partner Violence
  • Depression
  • Post Traumatic Stress Disorder