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Developing an Integrated Model for Home Visitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02410109
Enrollment
178
Registered
2015-04-07
Start date
2013-05-31
Completion date
2015-09-30
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms

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. 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.

Interventions

BEHAVIORALSCRIPT 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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in depressive symptomsBaseline, 3 months, 6 monthsChange in scores on the Beck Depression Inventory measured over 3 time points.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026