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Reducing Symptoms of Depression in Low-Income Mothers

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Modified Interpersonal Therapy
Attention control/usual care
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Early Head Start Program

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • P.E.A.C.E, Inc. Early Head Start
  • Asheville City Schools Preschool-Early Head Start Program
  • Chapel Hill Training Outreach Project, Inc. Early Head Start
  • University of North Carolina, Chapel Hill
  • W.A.G.E.S., Inc. Early Head Start Program
  • United Child Development Services, Inc. Early Head Start

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

Participants will receive attention control/usual care for 26 weeks

Outcomes

Primary Outcome Measures

Level of depressive symptoms

Secondary Outcome Measures

Mother child interactions

Full Information

First Posted
December 19, 2003
Last Updated
June 20, 2013
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00074789
Brief Title
Reducing Symptoms of Depression in Low-Income Mothers
Official Title
Reducing Depressive Symptoms in Low-Income Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Early Head Start Program

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive home-based interpersonal depression treatment for 26 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive attention control/usual care for 26 weeks
Intervention Type
Behavioral
Intervention Name(s)
Modified Interpersonal Therapy
Intervention Description
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
Intervention Name(s)
Attention control/usual care
Intervention Description
Participants will receive the usual care for depression.
Primary Outcome Measure Information:
Title
Level of depressive symptoms
Time Frame
Measured at Week 26
Secondary Outcome Measure Information:
Title
Mother child interactions
Time Frame
Measured at Week 26

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
P.E.A.C.E, Inc. Early Head Start
City
Syracuse
State/Province
New York
ZIP/Postal Code
13203
Country
United States
Facility Name
Asheville City Schools Preschool-Early Head Start Program
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Chapel Hill Training Outreach Project, Inc. Early Head Start
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-0001
Country
United States
Facility Name
W.A.G.E.S., Inc. Early Head Start Program
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-2570
Country
United States
Facility Name
United Child Development Services, Inc. Early Head Start
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27406
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33935214
Citation
Salomon RE, Muscatell KA, Crandell J, Anderson RA, Beeber LS. A Preliminary Investigation of Psychoneurological Symptoms in Low-Income Mothers. Nurs Res. 2021 Set/Oct 01;70(5):325-333. doi: 10.1097/NNR.0000000000000518.
Results Reference
derived

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Reducing Symptoms of Depression in Low-Income Mothers

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