Preventing Maternal Depression In Head Start

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Problem Solving Education and Activated Referral to Care

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 Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02118
      • ABCD Head Start

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 64 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Symptoms	QIDS	2 months
Depression Symptoms	QIDS	4 months
Depression Symptoms	QIDS	6 months
Depression Symptoms	QIDS	8 months
Depression Symptoms	QIDS	10 months
Depression Symptoms	QIDS	12 months
Problem Solving Skills	Social Problem Solving Inventory	6 months
Problem Solving Skills	Social Problem Solving Inventory	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social functioning	Social Adjustment Scale- Self-report	6 months
Parent functioning/stress	Parenting Stress Index; Perceived Stress Index	6 months
Head Start attendance	Head Start records, analyzed as monthly absence rates	12 months
Receipt of Mental Health Services		12 months
Social functioning	Social Adjustment Scale- Self-report	12 months
Parent functioning/stress	Parenting Stress Index, Perceived Stress Index	12 months
Child Behavior	Teacher Version of Social Skills Rating System	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Depressive Episode	SCID Interview	12 months
Post Traumatic Stress Disorder	SCID Interview	12 months
Anxiety	SCID Interview	12 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Head Start and Early Head Start Programs in Action for Boston Community Development Incorporated

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: R01MH091871 (U.S. NIH Grant/Contract)