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NCT02410109 · ClinicalTrials.gov registry record · NA

Developing an Integrated Model for Home Visitation

A NA study, sponsored by Johns Hopkins University.

Completed
Registry status
NA
Development phase
178
Enrollment target

NCT02410109: Completed NA study, sponsored by Johns Hopkins University.

NCT02410109 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 178 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02410109, a NA study, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
NA
Development phase
178 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • BEHAVIORAL SCRIPT integrated model

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2013-05
Est. Completion 2015-09
Phase NA
Johns Hopkins University

1,448 total trials

What the finished NCT02410109 record still lists

NCT02410109 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which SCRIPT integrated model is the first listed.

NCT02410109 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02410109 about?

NCT02410109 is a clinical study titled "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 v...

What is the current status of trial NCT02410109?

This trial is currently completed. It is a NA study. The enrollment target is 178 participants. The study started on 2013-05. Estimated completion is 2015-09.

What interventions are being tested in trial NCT02410109?

The interventions under investigation include: SCRIPT integrated model (BEHAVIORAL).

Who is sponsoring clinical trial NCT02410109?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02410109's enrollment target sits among peer trials

178 604th of 2000 higher than 1,397 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02410109, the US trial registry maintained by the National Library of Medicine. NCT02410109 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.