Developing an Integrated Model for Home Visitation

Depressive Symptoms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410109
• Other study ID #: NA_00071007
• Secondary ID: 1R34MH093514-01
• Status: Completed
• Phase: N/A
• First received: March 15, 2012
• Last updated: December 14, 2017
• Start date: May 2013
• Est. completion date: September 2015

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant or child < 6 months

• enrolled in Baltimore City home visiting program

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

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.

Locations

Country	Name	City	State
United States	DRUM Healthy Families	Baltimore	Maryland
United States	Maternal and Infant Nursing Program	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depressive symptoms	Change in scores on the Beck Depression Inventory measured over 3 time points.	Baseline, 3 months, 6 months