Completed

Reducing Depressive Symptoms in Low-Income Mothers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Modified Interpersonal Therapy

+ Attention control/usual care

Behavioral
Who is being recruted

Mental Disorders+2

+ Behavioral Symptoms

+ Depression

Over 15 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2003
See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2003

Actual date on which the first participant was enrolled.

Limited resources, poor social support, and complex life problems contribute to the high prevalence and severity of depressive symptoms in low-income mothers. As depressive symptoms persist, they often rob young mothers of the energy they need for school, job training, and positive interaction with their children, which can negatively affect a child's language acquisition, intellectual development, and social conduct. This study will design and implement a home-based treatment to help young mothers manage their depressive symptoms, increase their social support, manage or resolve life issues, and effectively parent their infant or toddler through the use of EHS resources. Mothers will be randomly assigned to receive either home-based interpersonal depression treatment or an attention control/usual care condition for 26 weeks. Assessments will be made at study start and Weeks 14, 22, and 26. Depression scales, interviews, and analyses of videotaped mother-child interactions will be used to assess participants. Stress, social support, and use of EHS services will be assessed.

Official TitleReducing Depressive Symptoms in Low-Income Mothers 
NCT00074789
Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

226 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBehavioral SymptomsDepressionDepressive DisorderMood Disorders

Criteria

Inclusion Criteria: * Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale * Child who is 6 weeks to 30 months old * Child who is enrolled in an Early Head Start program Exclusion Criteria: * Regular use of psychotropic medication * Regular use of psychotherapy or drug/alcohol treatment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive home-based interpersonal depression treatment for 26 weeks

Group II

Active Comparator
Participants will receive attention control/usual care for 26 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

P.E.A.C.E, Inc. Early Head Start

Syracuse, United StatesSee the location
Suspended

Asheville City Schools Preschool-Early Head Start Program

Asheville, United States
Suspended

Chapel Hill Training Outreach Project, Inc. Early Head Start

Chapel Hill, United States
Suspended

University of North Carolina, Chapel Hill

Chapel Hill, United States
Completed6 Study Centers