Helping mothers with depression to improve preschool outcomes
Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
NA · Brown University · NCT04092010
This study is testing a new program to help mothers with depression improve their own mental health and their preschool children's development while they are in Head Start programs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 388 (estimated) |
| Sex | Female |
| Sponsor | Brown University (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04092010 on ClinicalTrials.gov |
What this trial studies
This study evaluates a stepped-care intervention aimed at addressing maternal depression among mothers of preschool children enrolled in Head Start programs in Massachusetts. The intervention includes problem-solving education for mothers with mild symptoms and engagement sessions for those with more severe symptoms, linking them to formal mental health care. Over a 12-month period, the study will assess the impact of this intervention on both maternal mental health and child developmental outcomes. The approach is based on existing evidence supporting the efficacy and safety of the individual components of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are mothers of children aged 0 to 5 years enrolled in Head Start who are experiencing symptoms of depression.
Not a fit: Patients who may not benefit from this study include mothers with suicidal ideation or cognitive limitations.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health of mothers and enhance developmental outcomes for their preschool-aged children.
How similar studies have performed: Other studies have shown success with similar stepped-care approaches in addressing maternal mental health, indicating a promising avenue for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mother of a 0 to 5-year-old Head Start child * Mother speaks English or Spanish Exclusion Criteria: * Mother with suicidal ideation * Mother with cognitive limitation
Where this trial is running
Boston, Massachusetts
- Boston Medical Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Emily Feinberg, ScD CPNP — Brown University
- Study coordinator: Amy Yule, MD
- Email: amy.yule@bmc.org
- Phone: (617) 414-1936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Maternal Depression, Stepped care intervention, Problem solving education, Engagement session, Head Start, Preschool children