DepressionNCT01298804
Preventing Maternal Depression In Head Start
A study testing Problem Solving Education and Activated Referral to Care in people with Depression, run by Boston Medical Center at 2 sites in United States.
Trial summary
Maternal depression disproportionately affects low-income and minority women, and has profound negative impacts on their children. The investigators are conducting a randomized trial of a systems approach to identify mothers at risk for depression in Head Start - a federally funded early learning program for children… Read more about this study
- Who is it for?
- Ages 15 to 64 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Problem Solving Education and Activated Referral to Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Jul 2016
- 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 15 to 64 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Family enrolled in Head Start, and child expected to attend Head Start activities for at least 6 months of the 12-month follow-up period.
- Family without imminent plans to relocate
- Mother is comfortable in English or Spanish.
- Parent/guardian who has a child that attends Head Start
- Child attending Head Start and is between the ages 0-5
- Screen positive to 2-question depression screener (PHQ2), or have a past history of depression
- Ability to provide informed consent.
- Not suicidal
Who cannot join
- High suicidal ideation
- Cognitive limitation
- Psychosis
- No known risks for depression
- Symptoms reflecting major depressive episode
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ABCD Head Start
Boston, Massachusetts, 02118
Boston Medical Center
Boston, Massachusetts, 02118
About this study
Maternal depression disproportionately affects low-income and minority women, and has profound negative impacts on their children. The investigators are conducting a randomized trial of a systems approach to identify mothers at risk for depression in Head Start - a federally funded early learning program for children of low-income families - and to provide an on-site intervention to prevent or alleviate depressive symptoms; improve functioning; and, where appropriate, proactively link mothers to more definitive mental health services.
Read the detailed description
This study is one component of a series of studies that aims to develop a comprehensive system of maternal depression prevention and management within Head Start. In our March 2014 review of the CT.gov protocol, we synchronized it with our institution's IRB protocol, which had been modified based on how the individual studies within this series relate to one another. Specifically, the original IRB protocol combined two studies into one: a 'main' depression prevention trial (n=230, R01MH091871), and a small adjunct pilot aimed at referring those with symptoms of major depression to further care (n=60). Thus, the original CT.gov protocol included subjects both at risk for depression and with symptoms consistent with major depression. When the latter pilot study subsequently received external funding, we separated the two studies into two IRB protocols, and thus have adjusted our CT.gov protocol to the appropriate sample size of 230, and indicated symptoms of major depression as an exclusion criterion for the prevention trial. Because Major Depressive Episode was inadvertently listed as a primary outcome measure for the prevention trial (and PTSD and Anxiety as secondary outcome measures), we have removed them as such and listed it under 'other' outcomes, thereby aligning the CT.gov protocol with the statistical analysis plan of the original grant application and IRB protocol. Lastly, we corrected administrative errors in the study's projected end date and masking design.
- Conditions
- Depression
- Being tested
- Problem Solving Education and Activated Referral to Care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving Education and Activated Referral to CareBehavioural
The intervention represents an integrated identification and intervention system based on the evidence-based construct of screening, brief intervention, and referral to treatment (SBIRT). Within the comprehensive case management services of Head Start, eligible women will be randomized to receive either usual care or the Head Start-based intervention. In our intervention, mothers at risk for depression will receive a problem-solving intervention; depression symptom monitoring; and an "Activated" referral to more definitive services for those who have worsening symptoms over time.
| Study group | Role | What they receive |
|---|---|---|
| Problem Solving Education | Experimental | Not described Receives: Behavioral: Problem Solving Education and Activated Referral to Care |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Symptoms
QIDS
Measured: 2 months
Depression Symptoms
QIDS
Measured: 4 months
Depression Symptoms
QIDS
Measured: 6 months
Depression Symptoms
QIDS
Measured: 8 months
Depression Symptoms
QIDS
Measured: 10 months
Depression Symptoms
QIDS
Measured: 12 months
Problem Solving Skills
Social Problem Solving Inventory
Measured: 6 months
Problem Solving Skills
Social Problem Solving Inventory
Measured: 12 months
Secondary outcomes (7)
Social functioning
Social Adjustment Scale- Self-report
Measured: 6 months
Parent functioning/stress
Parenting Stress Index; Perceived Stress Index
Measured: 6 months
Head Start attendance
Head Start records, analyzed as monthly absence rates
Measured: 12 months
Receipt of Mental Health Services
Measured: 12 months
Social functioning
Social Adjustment Scale- Self-report
Measured: 12 months
Parent functioning/stress
Parenting Stress Index, Perceived Stress Index
Measured: 12 months
Child Behavior
Teacher Version of Social Skills Rating System
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Head Start and Early Head Start Programs in Action for Boston Community Development Incorporated
- Responsible party
- Principal investigator, Michael Silverstein, Boston Medical Center
- Investigators
- Michael Silverstein, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298804
- Sponsor's protocol ID
- R01MH091871
- Status last verified
- Aug 2016
- First submitted
- 16 Feb 2011
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Silverstein M, Cabral H, Hegel M, Diaz-Linhart Y, Beardslee W, Kistin CJ, Feinberg E. Problem-Solving Education to Prevent Depression Among Low-Income Mothers: A Path Mediation Analysis in a Randomized Clinical Trial. JAMA Netw Open. 2018 Jun 1;1(2):e180334. doi: 10.1001/jamanetworkopen.2018.0334.
PubMed 30646083Silverstein M, Diaz-Linhart Y, Cabral H, Beardslee W, Broder-Fingert S, Kistin CJ, Patts G, Feinberg E. Engaging Mothers With Depressive Symptoms in Care: Results of a Randomized Controlled Trial in Head Start. Psychiatr Serv. 2018 Nov 1;69(11):1175-1180. doi: 10.1176/appi.ps.201800173. Epub 2018 Sep 26.
PubMed 30256184Silverstein M, Diaz-Linhart Y, Cabral H, Beardslee W, Hegel M, Haile W, Sander J, Patts G, Feinberg E. Efficacy of a Maternal Depression Prevention Strategy in Head Start: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Aug 1;74(8):781-789. doi: 10.1001/jamapsychiatry.2017.1001.
PubMed 28614554
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Maternal Depression In Head Start
- ClinicalTrials.gov ID
- NCT01298804
- Acronym / sponsor ID
- R01MH091871
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Head Start and Early Head Start Programs in Action for Boston Community Development Incorporated
- Study start
- Feb 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Feb 2011 (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.
Maternal depression disproportionately affects low-income and minority women, and has profound negative impacts on their children. The investigators are conducting a randomized trial of a systems approach to identify mothers at risk for depression in Head Start - a federally funded early learning program for children of low-income families - and to provide an on-site intervention to prevent or alleviate depressive symptoms; improve functioning; and, where appropriate, proactively link mothers to more definitive mental health services.
Detailed description
This study is one component of a series of studies that aims to develop a comprehensive system of maternal depression prevention and management within Head Start. In our March 2014 review of the CT.gov protocol, we synchronized it with our institution's IRB protocol, which had been modified based on how the individual studies within this series relate to one another. Specifically, the original IRB protocol combined two studies into one: a 'main' depression prevention trial (n=230, R01MH091871), and a small adjunct pilot aimed at referring those with symptoms of major depression to further care (n=60). Thus, the original CT.gov protocol included subjects both at risk for depression and with symptoms consistent with major depression. When the latter pilot study subsequently received external funding, we separated the two studies into two IRB protocols, and thus have adjusted our CT.gov protocol to the appropriate sample size of 230, and indicated symptoms of major depression as an exclusion criterion for the prevention trial. Because Major Depressive Episode was inadvertently listed as a primary outcome measure for the prevention trial (and PTSD and Anxiety as secondary outcome measures), we have removed them as such and listed it under 'other' outcomes, thereby aligning the CT.gov protocol with the statistical analysis plan of the original grant application and IRB protocol. Lastly, we corrected administrative errors in the study's projected end date and masking design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem Solving Education | Experimental | Behavioral: Problem Solving Education and Activated Referral to Care |
| Control | No intervention | – |
Who may qualify
- Ages
- 15 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Family enrolled in Head Start, and child expected to attend Head Start activities for at least 6 months of the 12-month follow-up period.
- Family without imminent plans to relocate
- Mother is comfortable in English or Spanish.
- Parent/guardian who has a child that attends Head Start
- Child attending Head Start and is between the ages 0-5
Key exclusion criteria (5 listed)
- High suicidal ideation
- Cognitive limitation
- Psychosis
- No known risks for depression
- Symptoms reflecting major depressive episode
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 |
|---|---|---|
| Problem Solving Education and Activated Referral to CareThe intervention represents an integrated identification and intervention system based on the evidence-based construct of screening, brief intervention, and referral to treatment (SBIRT). Within the comprehensive case management services of Head Start, eligible women will be randomized to receive either usual care or the Head Start-based intervention. In our intervention, mothers at risk for depression will receive a problem-solving intervention; depression symptom monitoring; and an "Activated" referral to more definitive services for those who have worsening symptoms over time. | Behavioural | Problem Solving Education |
Primary outcome
Depression Symptoms
Time frame: 2 months
QIDS
Depression Symptoms
Time frame: 4 months
QIDS
Depression Symptoms
Time frame: 6 months
QIDS
Depression Symptoms
Time frame: 8 months
QIDS
Depression Symptoms
Time frame: 10 months
QIDS
Depression Symptoms
Time frame: 12 months
QIDS
Problem Solving Skills
Time frame: 6 months
Social Problem Solving Inventory
Problem Solving Skills
Time frame: 12 months
Social Problem Solving Inventory
7 secondary outcomes
Social functioning
Time frame: 6 months
Parent functioning/stress
Time frame: 6 months
Head Start attendance
Time frame: 12 months
Receipt of Mental Health Services
Time frame: 12 months
Social functioning
Time frame: 12 months
Parent functioning/stress
Time frame: 12 months
Child Behavior
Time frame: 6 months
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 9 Aug 2016.
- Derived from this study: PubMed 30646083Silverstein M, Cabral H, Hegel M, Diaz-Linhart Y, Beardslee W, Kistin CJ, Feinberg E. Problem-Solving Education to Prevent Depression Among Low-Income Mothers: A Path Mediation Analysis in a Randomized Clinical Trial. JAMA Netw Open. 2018 Jun 1;1(2):e180334. doi: 10.1001/jamanetworkopen.2018.0334.
- Derived from this study: PubMed 30256184Silverstein M, Diaz-Linhart Y, Cabral H, Beardslee W, Broder-Fingert S, Kistin CJ, Patts G, Feinberg E. Engaging Mothers With Depressive Symptoms in Care: Results of a Randomized Controlled Trial in Head Start. Psychiatr Serv. 2018 Nov 1;69(11):1175-1180. doi: 10.1176/appi.ps.201800173. Epub 2018 Sep 26.
- Derived from this study: PubMed 28614554Silverstein M, Diaz-Linhart Y, Cabral H, Beardslee W, Hegel M, Haile W, Sander J, Patts G, Feinberg E. Efficacy of a Maternal Depression Prevention Strategy in Head Start: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Aug 1;74(8):781-789. doi: 10.1001/jamapsychiatry.2017.1001.
Related trials for Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Recruiting
Teenthrive 2: Treatments for Improving Mood in Teens
Depression in Adolescence
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
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.
Michael Silverstein, MD, MPH principal investigator
Boston Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Education and Activated Referral to Care in people with Depression, run by Boston Medical Center at 2 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 8 inclusion and 5 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 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Depression Symptoms (time frame: 2 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01298804, which also lists 3 linked publications.
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 9 Aug 2016.