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Developing an Integrated Model for Home Visitation

Primary Purpose

Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCRIPT integrated model
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depressive Symptoms

Eligibility Criteria

14 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • pregnant or child < 6 months
  • enrolled in Baltimore City home visiting program

Sites / Locations

  • DRUM Healthy Families
  • Maternal and Infant Nursing Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SCRIPT intervention

Historical Control

Arm Description

Outcomes

Primary Outcome Measures

Change in depressive symptoms
Change in scores on the Beck Depression Inventory measured over 3 time points.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2012
Last Updated
December 14, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02410109
Brief Title
Developing an Integrated Model for Home Visitation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Perinatal depression is a significant concern, particularly for low-income women. Many cases of perinatal depression are complicated by comorbidities such as post-traumatic stress disorder symptoms, anxiety, and intimate partner violence. Providing perinatal mental health services to women in home visiting programs could have considerable public health significance. This study will develop and test an integrated model of mental health services embedded within home visitation (HV) programs. This model will (1) incorporate a protocol for systematic screening and referral; (2) strengthen formal linkages between HV programs and other components of service systems; (3) promote the capacity of service systems to provide evidence-based early intervention and treatment for depression; and (4) facilitate the receipt of early intervention and treatment services for perinatal depression and comorbid conditions. This will be the first model to our knowledge that systematically integrates screening, referral, and early intervention and treatment for perinatal depression and associated comorbidities within HV programs. The specific aims are: To develop an integrated model of perinatal depression care within HV programs. This integrated model ("SCRIPT") will incorporate screening, referral, and individualized prevention and treatment services. To assess the feasibility of implementing the SCRIPT model with high fidelity in two HV programs. One HV program-DRUM Healthy Families-will use paraprofessionals as interventionists while the other program-M&I Nursing-will use nurses and social workers as interventionists. To determine the impact of the SCRIPT model on depressive symptoms and major depressive episodes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCRIPT intervention
Arm Type
Experimental
Arm Title
Historical Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
SCRIPT integrated model
Intervention Description
Perinatal women will be screened for psychosocial risks at time of home visiting enrollment. Women exhibiting elevated depressive symptoms and/or have a history of clinical depression who are not currently clinically depressed will be referred for depression prevention services. Women experiencing a depressive episode will be referred for group CBT. Women who screen positive for elevated anxiety symptoms, PTSD symptoms, intimate partner violence, or substance abuse will be referred to a mental health or social service agencies. If a client is referred for services, the assessment worker will provide written educational materials about the risk factor that is being addressed through the referral. At the first home visit, the home visitor will discuss these educational materials.
Primary Outcome Measure Information:
Title
Change in depressive symptoms
Description
Change in scores on the Beck Depression Inventory measured over 3 time points.
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pregnant or child < 6 months enrolled in Baltimore City home visiting program
Facility Information:
Facility Name
DRUM Healthy Families
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21217
Country
United States
Facility Name
Maternal and Infant Nursing Program
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Developing an Integrated Model for Home Visitation

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