DepressionPhase 2NCT01175603
Preventing Postpartum Depression in African American Home Visiting Clients
A Phase 2 study testing Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs) in people with Depression, run by Johns Hopkins University at 4 sites in United States.
Trial summary
The goal of this study is to determine whether a 6 week intervention is effective in preventing the worsening of depressive symptoms and development of clinical depression in low-income African American pregnant and recently delivered women who are enrolled in home visiting programs. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 2
- 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 14 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- pregnant or has child < 6 months of age
- enrolled in home visiting program
- exhibiting elevated depressive symptoms and/or personal history of clinical depression
Who cannot join
- no current clinical depression at time of enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
People's Community Health Center
Baltimore, Maryland, 20001
DRUM Healthy Families
Baltimore, Maryland
Maternal and Infant Nursing Program
Baltimore, Maryland
Sinai Hospital Perinatal Depression Outreach Program
Baltimore, Maryland
About this study
The goal of this study is to determine whether a 6 week intervention is effective in preventing the worsening of depressive symptoms and development of clinical depression in low-income African American pregnant and recently delivered women who are enrolled in home visiting programs.
Read the detailed description
This study will conduct a randomized controlled trial (RCT) with women from four Baltimore City home visiting programs. We will screen 200 women who are pregnant or have a child < 6 months for study inclusion; 91 women at elevated risk for developing postpartum depression (PPD) will be randomized to an intervention (MB Course) or usual home visiting control group. Women in the intervention group will receive the 6-week MB Course delivered in a group setting by the Study Clinician with reinforcing messages provided by home visitors during 1-on-1 home visits, while women in the attention control will receive usual home visiting services and information on postpartum depression. Primary outcomes include depressive symptoms and depressive episodes.
- Conditions
- Depression
- Being tested
- Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)
- Keywords
- depression, African American, home visiting, prevention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)Behavioural
6 weekly 2-hour cognitive-behavioral intervention sessions held in group format
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral intervention | Experimental | Women in the intervention condition will receive 6 two-hour intervention sessions delivered weekly in a group format by the Study Clinician. Each session contains didactic instruction on core content, as well as activities and group discussion. One of the strengths of embedding the MB Course within home visiting is our ability to have home visitors reinforce the material presented by the Study Clinician. The 6-week curriculum is divided into three modules: (a) pleasant activities, (b) thoughts, and (c) relationships with others. Each module has two sessions. These sessions map onto core cognitive-behavioral concepts. Receives: Behavioral: Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs) |
| Usual home visiting | No intervention | Women in the control group will receive usual home visiting services and information on postpartum depression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Measured: Baseline
Depressive symptoms
Measured: 1 week post intervention
Depressive Symptoms
Measured: 3 months post-intervention
Depressive symptoms
Measured: 6 months post-intervention
Secondary outcomes (2)
Depressive episodes
Measured: 3 months post-intervention
Depressive Episodes
Measured: 6 Months Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Abell Foundation
- Responsible party
- Sponsor
- Investigators
- Shiv D Tandon, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175603
- Sponsor's protocol ID
- JHMI ICTR 2009
- Other IDs
- ICTR 2009
- Status last verified
- Apr 2016
- First submitted
- 3 Aug 2010
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Postpartum Depression in African American Home Visiting Clients
- ClinicalTrials.gov ID
- NCT01175603
- Acronym / sponsor ID
- JHMI ICTR 2009
- Conditions
- Depression
- Keywords
- depression, African American, home visiting, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Abell Foundation
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 Aug 2010 (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.
The goal of this study is to determine whether a 6 week intervention is effective in preventing the worsening of depressive symptoms and development of clinical depression in low-income African American pregnant and recently delivered women who are enrolled in home visiting programs.
Detailed description
This study will conduct a randomized controlled trial (RCT) with women from four Baltimore City home visiting programs. We will screen 200 women who are pregnant or have a child < 6 months for study inclusion; 91 women at elevated risk for developing postpartum depression (PPD) will be randomized to an intervention (MB Course) or usual home visiting control group. Women in the intervention group will receive the 6-week MB Course delivered in a group setting by the Study Clinician with reinforcing messages provided by home visitors during 1-on-1 home visits, while women in the attention control will receive usual home visiting services and information on postpartum depression. Primary outcomes include depressive symptoms and depressive episodes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral intervention | Experimental | Behavioral: Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)Women in the intervention condition will receive 6 two-hour intervention sessions delivered weekly in a group format by the Study Clinician. Each session contains didactic instruction on core content, as well as activities and group discussion. One of the strengths of embedding the MB Course within home visiting is our ability to have home visitors reinforce the material presented by the Study Clinician. The 6-week curriculum is divided into three modules: (a) pleasant activities, (b) thoughts, and (c) relationships with others. Each module has two sessions. These sessions map onto core cognitive-behavioral concepts. |
| Usual home visiting | No intervention | –Women in the control group will receive usual home visiting services and information on postpartum depression. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- pregnant or has child < 6 months of age
- enrolled in home visiting program
- exhibiting elevated depressive symptoms and/or personal history of clinical depression
Key exclusion criteria (1 listed)
- no current clinical depression at time of enrollment
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 |
|---|---|---|
| Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)6 weekly 2-hour cognitive-behavioral intervention sessions held in group format | Behavioural | Cognitive behavioral intervention |
Primary outcome
Depressive symptoms
Time frame: Baseline
Depressive symptoms
Time frame: 1 week post intervention
Depressive Symptoms
Time frame: 3 months post-intervention
Depressive symptoms
Time frame: 6 months post-intervention
2 secondary outcomes
Depressive episodes
Time frame: 3 months post-intervention
Depressive Episodes
Time frame: 6 Months Post-Intervention
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 7 Apr 2016.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Shiv D Tandon, PhD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs) in people with Depression, run by Johns Hopkins University at 4 sites 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 3 inclusion and 1 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 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Depressive symptoms (time frame: Baseline). The study lists 4 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 7 Apr 2016.