Developing an Integrated Model for Home Visitation

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:

1. 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.
2. 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.
3. To determine the impact of the SCRIPT model on depressive symptoms and major depressive episodes.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms
• Intervention / Treatment: Behavioral: SCRIPT integrated model

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21217
      • DRUM Healthy Families
    • Baltimore, Maryland, United States, 21287
      • Maternal and Infant Nursing Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCRIPT intervention	Behavioral: SCRIPT integrated model; 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.
No Intervention: Historical Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms	Change in scores on the Beck Depression Inventory measured over 3 time points.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 15, 2012
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: NA_00071007; 1R34MH093514-01 (U.S. NIH Grant/Contract)