Postpartum Major DepressionT-BOOMNCT00745537
T- BOOM Teens--Building Options and Opportunities for Moms
A study testing repeated mood measures and phone depression care management in people with Postpartum Major Depression, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years, women only
- Conditions the study is for
- Postpartum Major Depression
- What is being tested?
- repeated mood measures and phone depression care management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Teens--Building Options and Opportunities for Moms
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.
Read the detailed 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.
- Conditions
- Postpartum Major Depression
- Being tested
- repeated mood measures and phone depression care management
- Keywords
- postpartum major depression, adolescent mothers, telephone depression care management, barriers to depression care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated mood measures and phone depression care managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Mother | Experimental | aged less than 17 years old and recently gave birth Receives: Other: repeated mood measures and phone depression care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of PPD will be assessed with the Children's Depression Rating Scale (CDRS).
Measured: Trained interviewers will complete the CDRS at baseline, 3, 6, and 12 months postpartum.
Edinburgh Postnatal Depression Scale
Measured: Baseline, 3, 6, and 12 months
Center for Epidemiologic Studies of Depression instrument (CES-D)
Measured: Baseline, 3, 6 and 12 months
Secondary outcomes (4)
A specific measure of functioning at school or work and with peers, the Children's Global Assessment of Functioning (C-GAS) will be obtained.
Measured: baseline, 3, 6, and 12 months
The Social Function-12 (SF-12; Ware et al., 1993) is the most widely used measure of health-related functioning.
Measured: baseline, 3, 6, 12 months
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).
Measured: baseline, 3, 6 and 12 months
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).
Measured: Baseline, 3, 6 and 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Major DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Wisner, University of Pittsburgh
- Investigators
- Katherine L Wisner, M.D., Principal investigator, 3811 O'Hara Street, Oxford 410, Pittsburgh, PA 15123
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745537
- Sponsor's protocol ID
- B7473
- Acronym
- T-BOOM
- Status last verified
- May 2015
- First submitted
- 2 Sep 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teens--Building Options and Opportunities for Moms
- ClinicalTrials.gov ID
- NCT00745537
- Acronym / sponsor ID
- T-BOOM / B7473
- Conditions
- Postpartum Major Depression
- Keywords
- postpartum major depression, adolescent mothers, telephone depression care management, barriers to depression care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent Mother | Experimental | Other: repeated mood measures and phone depression care managementaged less than 17 years old and recently gave birth |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repeated mood measures and phone depression care managementThe 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. | Other | Adolescent Mother |
Primary outcome
Severity of PPD will be assessed with the Children's Depression Rating Scale (CDRS).
Time frame: Trained interviewers will complete the CDRS at baseline, 3, 6, and 12 months postpartum.
Edinburgh Postnatal Depression Scale
Time frame: Baseline, 3, 6, and 12 months
Center for Epidemiologic Studies of Depression instrument (CES-D)
Time frame: Baseline, 3, 6 and 12 months
4 secondary outcomes
A specific measure of functioning at school or work and with peers, the Children's Global Assessment of Functioning (C-GAS) will be obtained.
Time frame: baseline, 3, 6, and 12 months
The Social Function-12 (SF-12; Ware et al., 1993) is the most widely used measure of health-related functioning.
Time frame: baseline, 3, 6, 12 months
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).
Time frame: baseline, 3, 6 and 12 months
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).
Time frame: Baseline, 3, 6 and 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine L Wisner, M.D. principal investigator
3811 O'Hara Street, Oxford 410, Pittsburgh, PA 15123
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repeated mood measures and phone depression care management in people with Postpartum Major Depression, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of PPD will be assessed with the Children's Depression Rating Scale (CDRS). (time frame: Trained interviewers will complete the CDRS at baseline, 3, 6, and 12 months postpartum.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.