Clinical trial NCT00074789: Reducing Symptoms of Depression in Low-Income Mothers
Official title: Reducing Depressive Symptoms in Low-Income Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: Early Head Start Program
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-12-22
Enrollment: 226
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Level of depressive symptoms
timeFrame: Measured at Week 26
Secondary outcomes:
measure: Mother child interactions
timeFrame: Measured at Week 26
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: P.E.A.C.E, Inc. Early Head Start
state: New York
city: Asheville
country: United States
facility: Asheville City Schools Preschool-Early Head Start Program
state: North Carolina
city: Chapel Hill
country: United States
facility: Chapel Hill Training Outreach Project, Inc. Early Head Start
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Goldsboro
country: United States
facility: W.A.G.E.S., Inc. Early Head Start Program
state: North Carolina
city: Greensboro
country: United States
facility: United Child Development Services, Inc. Early Head Start
state: North Carolina
Study officials:
References:
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.