This trial is active, not recruiting.

Condition depressive symptoms
Treatment script integrated model
Phase phase 1/phase 2
Sponsor Johns Hopkins University
Collaborator National Institute of Mental Health (NIMH)
Start date May 2013
End date October 2016
Trial size 178 participants
Trial identifier NCT02410109, 1R34MH093514-01, NA_00071007


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
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)

Primary Outcomes

Change in depressive symptoms
time frame: Baseline, 3 months, 6 months

Eligibility Criteria

Female participants from 14 years up to 45 years old.

Inclusion Criteria: - pregnant or child < 6 months - enrolled in Baltimore City home visiting program

Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Johns Hopkins University.