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Preventing Maternal Depression In Head Start

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01298804
First Posted: February 18, 2011
Last Update Posted: August 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Head Start and Early Head Start Programs in Action for Boston Community Development Incorporated
Information provided by (Responsible Party):
Michael Silverstein, Boston Medical Center
  Purpose
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.

Condition Intervention
Depression Behavioral: Problem Solving Education and Activated Referral to Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Maternal Depression In Head Start

Further study details as provided by Michael Silverstein, Boston Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Social functioning [ Time Frame: 6 months ]
    Social Adjustment Scale- Self-report

  • Parent functioning/stress [ Time Frame: 6 months ]
    Parenting Stress Index; Perceived Stress Index

  • Head Start attendance [ Time Frame: 12 months ]
    Head Start records, analyzed as monthly absence rates

  • Receipt of Mental Health Services [ Time Frame: 12 months ]
  • Social functioning [ Time Frame: 12 months ]
    Social Adjustment Scale- Self-report

  • Parent functioning/stress [ Time Frame: 12 months ]
    Parenting Stress Index, Perceived Stress Index

  • Child Behavior [ Time Frame: 6 months ]
    Teacher Version of Social Skills Rating System


Other Outcome Measures:
  • Major Depressive Episode [ Time Frame: 12 months ]
    SCID Interview

  • Post Traumatic Stress Disorder [ Time Frame: 12 months ]
    SCID Interview

  • Anxiety [ Time Frame: 12 months ]
    SCID Interview


Enrollment: 230
Study Start Date: February 2011
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Problem Solving Education Behavioral: Problem Solving Education and Activated Referral to Care
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.
No Intervention: Control

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • High suicidal ideation
  • Cognitive limitation
  • Psychosis
  • No known risks for depression
  • Symptoms reflecting major depressive episode
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298804


Locations
United States, Massachusetts
ABCD Head Start
Boston, Massachusetts, United States, 02118
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Head Start and Early Head Start Programs in Action for Boston Community Development Incorporated
Investigators
Principal Investigator: Michael Silverstein, MD, MPH Boston Medical Center
  More Information

Responsible Party: Michael Silverstein, Associate Professor of Pediatrics, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01298804     History of Changes
Other Study ID Numbers: R01MH091871 ( U.S. NIH Grant/Contract )
First Submitted: February 16, 2011
First Posted: February 18, 2011
Last Update Posted: August 9, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders