T- BOOM Teens--Building Options and Opportunities for Moms

Postpartum Major Depression Clinical Trial

— T-BOOM  

Official title:

Teens--Building Options and Opportunities for Moms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745537
• Other study ID #: B7473
• Status: Completed
• Phase: N/A
• First received: September 2, 2008
• Last updated: May 27, 2015
• Start date: April 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Postpartum depression (PPD) is depression that occurs shortly after the mother delivers her baby. Mothers with postpartum depression may feel sad mood, low motivation or stress; some may have problems caring for their new baby. Successful depression treatment involves early screening and detection of postpartum depression and early access to treatment services.

The purpose of this study is to evaluate the effectiveness of a telephone-based depression screening and care management program for postpartum women. We will evaluate the: 1) how often (frequency) young mothers develop symptoms of depression 4 to 6 weeks after birth, 2) how quickly (timeliness) young mother receive treatment and how effective (adequacy) are the treatments for the symptoms of postpartum depression, 3) the effects of depression care support on young mothers' symptoms and their ability to function at 3, 6 and 12 months after entering the study, 4) visits to the pediatrician or nurse practitioner (preventive health services) during their baby's first year of life, and 5) cost and cost savings associated with depression care management.

Description:

Depression during the perinatal period is a major public health concern. Postpartum depression (PPD) causes personal and family suffering at a time when adaptation to parenthood is critical. Successful interventions for treating depression in medical settings have been framed by a chronic disease management model. The key ingredient to success is a dedicated care manager who provides education and support to patients, actively coordinates care, and thereby improves treatment outcomes for patients. Compared to interventions in medical office settings, telephone care management positioned at the level of the health plan offers a systematic and efficient mechanism for ongoing treatment support of women with PPD, particularly in a geographically dispersed population.

We propose to conduct a comprehensive project to improve treatment outcomes for depressed postpartum women through adaptation of the depression care management model used in primary care settings. The major components are: 1) depression screening in a population of postpartum adolescents, 2) depression education for all who screen positive, 3) a diagnostic interview to evaluate for depressive disorders in mothers who score above and below a defined threshold on the screening instrument, 4) telephone-based care management intervention, and 5) longitudinal evaluation across the first year post-birth for depression and maternal and child public health outcomes. Focus groups will precede the major study components. A focus group of adolescent mothers will inform the investigators about the barriers to depression care management that encompass resource needs, acceptability of interventions to cope with stress or depression, and access to care. A separate focus group of community professionals of representatives from agencies or groups that provide community supports and health services will be used to explore the perceptions of barriers to care for new adolescent mothers. All participants in this project will be eligible for mental health services through their health plans that serve Medicaid and commercial members.

We plan to identify 125 child or adolescent new mothers with PPD. The child or adolescent new mothers will be assigned to depression care management. They will be supported in making choices about depression treatment (after receiving education about options), encouraged to access their preferred treatment (through the direct discussion of barriers and solutions), counseled to comply with treatment recommendations, and assisted to problem-solve if failure to respond occurs. All participants will have systematic evaluations at 3, 6, and 12 months post-birth. Outcomes include not only maternal depressive symptom levels but also functional and public health outcomes for mothers, families, and infants. We have developed a multi-disciplinary team with expertise in clinical research with depressed and minority women and health services to address these needs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Adolescent mothers age < 17 years 364 days at birth of index infant

• Live born infants

• Parents/guardian of the young mother must be available and competent to provide consent to the enrollment of the young mother

• The young mother may provide assent for her own enrollment.

• Ethical need for awareness of the possible risks, benefits and alternatives to enrollment in this study.

• Mothers with an EPDS>/=10 or CES-D>/=16 (suggest increased risk for major depression)

• Mothers with major depressive disorder (MDD) regardless of their EPDS or CES-D scores. These are patients with high risk for severe recurrence of depressive symptoms in the postpartum. We will assess their outcomes in this study.

• Adolescent mothers with an EPDS<10 OR CES-D<16 (screen negative) without MDD will be interviewed by phone with the KIDDIE-SADS mood screen to screen for all categories of major diagnoses AND the Mood Disorders Module

Exclusion Criteria:

• No access to a telephone Screening and depression care management are accomplished by phone; mothers with no phone are referred to Magee social work for other services

• NON-English-speaking Measures are in English

• The multiple questionnaires and measures are in English

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• Postpartum Major Depression

Intervention

Other:
• repeated mood measures and phone depression care management
The adolescent mothers will be assigned a depression care management who will support the mother in making choices about depression treatment, educate about treatment options, discuss barriers and solutions, counsel to comply with treatment recommendations, and assisted to problem-solve if failure to respond occurs.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of PPD will be assessed with the Children's Depression Rating Scale (CDRS).		Trained interviewers will complete the CDRS at baseline, 3, 6, and 12 months postpartum.	Yes
Primary	Edinburgh Postnatal Depression Scale		Baseline, 3, 6, and 12 months	Yes
Primary	Center for Epidemiologic Studies of Depression instrument (CES-D)		Baseline, 3, 6 and 12 months	Yes
Secondary	A specific measure of functioning at school or work and with peers, the Children's Global Assessment of Functioning (C-GAS) will be obtained.		baseline, 3, 6, and 12 months	Yes
Secondary	The Social Function-12 (SF-12; Ware et al., 1993) is the most widely used measure of health-related functioning.		baseline, 3, 6, 12 months	No
Secondary	The Inventory of Functional Status after Birth (IFSAC) was used in studies of postpartum women to measure the woman's readiness to assume infant care and resume usual activities (Fawcett et al., 1988).		baseline, 3, 6 and 12 months	No
Secondary	To assess the mother-infant relational quality, the Gratification in the Maternal Role (GRAT) is a 14-item checklist in which women rate each item on a 5 point scale (Mercer, 1985).		Baseline, 3, 6 and 12months	No