RECRUITING

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

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

Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.

Official Title

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

Quick Facts

Study Start:2023-08-16
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04092010

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:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Mother of a 0 to 5-year-old Head Start child
  2. * Mother speaks English or Spanish
  1. * Mother with suicidal ideation
  2. * Mother with cognitive limitation

Contacts and Locations

Study Contact

Amy Yule, MD
CONTACT
(617) 414-1936
amy.yule@bmc.org
Jocelyn Antonio, MPH
CONTACT
401-863-2259
Jocelyn_antonio@brown.edu

Principal Investigator

Emily Feinberg, ScD CPNP
PRINCIPAL_INVESTIGATOR
Brown University
Michael Silverstein, MD
PRINCIPAL_INVESTIGATOR
Brown University
Amy Yule, MD
PRINCIPAL_INVESTIGATOR
Boston Medical Center

Study Locations (Sites)

Boston Medical Center
Boston, Massachusetts, 02119
United States

Collaborators and Investigators

Sponsor: Brown University

  • Emily Feinberg, ScD CPNP, PRINCIPAL_INVESTIGATOR, Brown University
  • Michael Silverstein, MD, PRINCIPAL_INVESTIGATOR, Brown University
  • Amy Yule, MD, PRINCIPAL_INVESTIGATOR, Boston Medical Center

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 Date2023-08-16
Study Completion Date2028-04

Study Record Updates

Study Start Date2023-08-16
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

  • Stepped care intervention
  • Problem solving education
  • Engagement session
  • Head Start
  • Preschool children

Additional Relevant MeSH Terms

  • Maternal Depression