Preventing Maternal Depression In Head Start

This study is currently recruiting participants.
Verified March 2014 by Boston Medical Center
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01298804
First received: February 16, 2011
Last updated: March 6, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Maternal Depression In Head Start

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Depression Symptoms [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    QIDS

  • Depression Symptoms [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    QIDS

  • Depression Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    QIDS

  • Depression Symptoms [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    QIDS

  • Depression Symptoms [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    QIDS

  • Depression Symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    QIDS

  • Problem Solving Skills [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Social Problem Solving Inventory

  • Problem Solving Skills [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Social Problem Solving Inventory


Secondary Outcome Measures:
  • Social functioning [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Social Adjustment Scale- Self-report

  • Parent functioning/stress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Parenting Stress Index; Perceived Stress Index

  • Head Start attendance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Head Start records, analyzed as monthly absence rates

  • Receipt of Mental Health Services [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Social functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Social Adjustment Scale- Self-report

  • Parent functioning/stress [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Parenting Stress Index, Perceived Stress Index

  • Child Behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Teacher Version of Social Skills Rating System


Other Outcome Measures:
  • Major Depressive Episode [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    SCID Interview

  • Post Traumatic Stress Disorder [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    SCID Interview

  • Anxiety [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    SCID Interview


Estimated Enrollment: 230
Study Start Date: April 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   15 Years to 64 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298804

Contacts
Contact: Michael Silverstein, MD, MPH 617-414-7903 michael.silverstein@bmc.org

Locations
United States, Massachusetts
ABCD Head Start Recruiting
Boston, Massachusetts, United States, 02118
Contact: Barbara Jacobs    617-426-2855      
Principal Investigator: Michael Silverstein, MD, MPH         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Michael Silverstein, MD, MPH         
Principal Investigator: Michael Silverstein, MD, MPH         
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

No publications provided

Responsible Party: Michael Silverstein, Associate Professor of Pediatrics, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01298804     History of Changes
Other Study ID Numbers: R01MH091871
Study First Received: February 16, 2011
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014