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Trial record 2 of 630 for:    i nursing

Developing an Integrated Model for Home Visitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02410109
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : December 18, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Behavioral: SCRIPT integrated model Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Actual Study Start Date : May 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Change in depressive symptoms [ Time Frame: Baseline, 3 months, 6 months ]
    Change in scores on the Beck Depression Inventory measured over 3 time points.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02410109

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United States, Maryland
DRUM Healthy Families
Baltimore, Maryland, United States, 21217
Maternal and Infant Nursing Program
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute of Mental Health (NIMH)
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Responsible Party: Johns Hopkins University Identifier: NCT02410109    
Other Study ID Numbers: NA_00071007
1R34MH093514-01 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Behavioral Symptoms