Preventing Maternal Depression In Head Start

Depression Clinical Trial

Official title:

Preventing Maternal Depression In Head Start

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298804
• Other study ID #: R01MH091871
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: August 8, 2016
• Start date: February 2011
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	ABCD Head Start	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Head Start and Early Head Start Programs in Action for Boston Community Development Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major Depressive Episode	SCID Interview	12 months	No
Other	Post Traumatic Stress Disorder	SCID Interview	12 months	No
Other	Anxiety	SCID Interview	12 months	No
Primary	Depression Symptoms	QIDS	2 months	No
Primary	Depression Symptoms	QIDS	4 months	No
Primary	Depression Symptoms	QIDS	6 months	No
Primary	Depression Symptoms	QIDS	8 months	No
Primary	Depression Symptoms	QIDS	10 months	No
Primary	Depression Symptoms	QIDS	12 months	No
Primary	Problem Solving Skills	Social Problem Solving Inventory	6 months	No
Primary	Problem Solving Skills	Social Problem Solving Inventory	12 months	No
Secondary	Social functioning	Social Adjustment Scale- Self-report	6 months	No
Secondary	Parent functioning/stress	Parenting Stress Index; Perceived Stress Index	6 months	No
Secondary	Head Start attendance	Head Start records, analyzed as monthly absence rates	12 months	No
Secondary	Receipt of Mental Health Services		12 months	No
Secondary	Social functioning	Social Adjustment Scale- Self-report	12 months	No
Secondary	Parent functioning/stress	Parenting Stress Index, Perceived Stress Index	12 months	No
Secondary	Child Behavior	Teacher Version of Social Skills Rating System	6 months	No