NCT01298804

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

5.4 years

First QC Date

February 16, 2011

Last Update Submit

August 8, 2016

Conditions

Depression

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (7)

  • Social functioning

    6 months

  • Parent functioning/stress

    6 months

  • Head Start attendance

    12 months

  • Receipt of Mental Health Services

    12 months

  • Social functioning

    12 months

  • +2 more secondary outcomes

Other Outcomes (3)

  • Major Depressive Episode

    12 months

  • Post Traumatic Stress Disorder

    12 months

  • Anxiety

    12 months

Study Arms (2)

Problem Solving Education

EXPERIMENTAL
Behavioral: Problem Solving Education and Activated Referral to Care

Control

NO INTERVENTION

Interventions

Problem Solving Education and Activated Referral to CareBEHAVIORAL

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.

Problem Solving Education

Eligibility Criteria

Age15 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • High suicidal ideation
  • Cognitive limitation
  • Psychosis
  • No known risks for depression
  • Symptoms reflecting major depressive episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ABCD Head Start

Boston, Massachusetts, 02118, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

  • 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.

    PMID: 30646083DERIVED

  • 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.

    PMID: 30256184DERIVED

  • 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.

    PMID: 28614554DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Michael Silverstein, MD, MPH

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 18, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

US(2)