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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT01298804
Study groupRoleWhat they receive
Problem Solving EducationExperimentalNot described
Receives: Behavioral: Problem Solving Education and Activated Referral to Care
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression Symptoms

    QIDS

    Measured: 2 months

  2. Depression Symptoms

    QIDS

    Measured: 4 months

  3. Depression Symptoms

    QIDS

    Measured: 6 months

  4. Depression Symptoms

    QIDS

    Measured: 8 months

  5. Depression Symptoms

    QIDS

    Measured: 10 months

  6. Depression Symptoms

    QIDS

    Measured: 12 months

  7. Problem Solving Skills

    Social Problem Solving Inventory

    Measured: 6 months

  8. Problem Solving Skills

    Social Problem Solving Inventory

    Measured: 12 months

Secondary outcomes (7)

  1. Social functioning

    Social Adjustment Scale- Self-report

    Measured: 6 months

  2. Parent functioning/stress

    Parenting Stress Index; Perceived Stress Index

    Measured: 6 months

  3. Head Start attendance

    Head Start records, analyzed as monthly absence rates

    Measured: 12 months

  4. Receipt of Mental Health Services

    Measured: 12 months

  5. Social functioning

    Social Adjustment Scale- Self-report

    Measured: 12 months

  6. Parent functioning/stress

    Parenting Stress Index, Perceived Stress Index

    Measured: 12 months

  7. 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.

  1. First posted18 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

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)
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 30646083

  • Silverstein 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 30256184

  • Silverstein 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

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; AzTrials last refreshed its copy on 27 Oct 2026.

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