Developing an Integrated Model for Home Visitation

NCT02410109 | Completed

• 2 other identifiers: NA_000710071R34MH093514-01
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 2

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:

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

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms

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

  Baseline, 3 months, 6 months

Study Arms (2)

SCRIPT intervention

EXPERIMENTAL

Behavioral: SCRIPT integrated model

Historical Control

NO INTERVENTION

Interventions

SCRIPT integrated model BEHAVIORAL

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.

SCRIPT intervention

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

DRUM Healthy Families

Baltimore, Maryland, 21217, United States

Location

Maternal and Infant Nursing Program

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: April 7, 2015
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

US (2)