Reducing Symptoms of Depression in Low-Income Mothers

Phase 2

Completed

• Conditions: Depression
• Interventions: Behavioral: Attention control/usual care; Behavioral: Modified Interpersonal Therapy

• Registration Number: NCT00074789
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-12-19
• Study First Submitted QC: 2003-12-19
• Study First Posted: 2003-12-22
• Primary Completion: 2008-09
• Study Completion: 2009-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 226

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

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Exclusion Criteria

• Regular use of psychotropic medication
• Regular use of psychotherapy or drug/alcohol treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Attention control/usual care	Participants will receive attention control/usual care for 26 weeks
1	Modified Interpersonal Therapy	Participants will receive home-based interpersonal depression treatment for 26 weeks

Primary Outcome Measures

Name	Time	Method
Level of depressive symptoms	Measured at Week 26

Secondary Outcome Measures

Name	Time	Method
Mother child interactions	Measured at Week 26

Trial Locations

Locations (6)

P.E.A.C.E, Inc. Early Head Start; 🇺🇸 Syracuse, New York, United States

Asheville City Schools Preschool-Early Head Start Program; 🇺🇸 Asheville, North Carolina, United States

United Child Development Services, Inc. Early Head Start; 🇺🇸 Greensboro, North Carolina, United States

W.A.G.E.S., Inc. Early Head Start Program; 🇺🇸 Goldsboro, North Carolina, United States

Chapel Hill Training Outreach Project, Inc. Early Head Start; 🇺🇸 Chapel Hill, North Carolina, United States

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States