Reducing Symptoms of Depression in Low-Income Mothers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will test the effectiveness of a short-term intervention in treating depressed young mothers with young children enrolled in Early Head Start Programs.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Technology to Enhance Treatment for Early Conduct Problems in Low Income Families

NCT02191956

Disruptive Behavior Disorders

COMPLETED NA

Psychotherapy for Depressed Mothers of Psychiatrically Ill Children

NCT00919594

Depression

COMPLETED NA

Integrated Parent Training for Treating Depression in Mothers of Children With Attention Deficit Hyperactivity Disorder

NCT00316290

Depression Attention Deficit Disorder With Hyperactivity

COMPLETED NA

A Clinic-based Prevention Program for Families of Depressed Mothers

NCT00149812

Depression Attention Deficit Disorder With Hyperactivity Conduct Disorder

COMPLETED PHASE1

Preventing Depression in the Children of Depressed African American Mothers

NCT00904917

Depression

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type EXPERIMENTAL

Modified Interpersonal Therapy

Intervention Type BEHAVIORAL

Psychiatric mental health nurses will meet with participants 10 times, an hour each time, over a period of 14 weeks. The nurses will continue to work with the mothers over the next 8 weeks by phone, conducting 5 fifteen minute phone sessions.

2

Participants will receive attention control/usual care for 26 weeks

Group Type ACTIVE_COMPARATOR

Attention control/usual care

Intervention Type BEHAVIORAL

Participants will receive the usual care for depression.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Modified Interpersonal Therapy

Psychiatric mental health nurses will meet with participants 10 times, an hour each time, over a period of 14 weeks. The nurses will continue to work with the mothers over the next 8 weeks by phone, conducting 5 fifteen minute phone sessions.

Intervention Type BEHAVIORAL

Attention control/usual care

Participants will receive the usual care for depression.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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