Strengthening Families and Reducing Risk Thru Developmental and Legal Collaboration — dulce  

Child Development Clinical Trial

Official title: Project Dulce: Developmental Understanding and Legal Collaboration for Everyone

Status Completed

Clinical Trial Summary

Project Dulce is designed to test a new approach to delivering family support, in the context of the primary care medical home. The target population to be served is infants between birth and 6 months old and their families who receive primary care at Boston Medical Center. A dulce family partner will reach infants and families through their routine health care visits during their first six months of life and provide them with support for unmet legal needs, screen infants for developmental problems, screen families for mental health problems, and improve families' knowledge of child development. The control group will receive training on safe sleep and safe transportation for their newborn.

Clinical Trial Description

Subjects for project dulce will be recruited from parents who receive their newborn child's primary pediatric care from Boston Medical Center's Pediatric Primary Care Clinic. Subjects will be randomized to receive the study intervention or the control.

Project dulce will provide a family partner to parents of infants up to six months of age. The dulce family partner (DFP) will be trained using the Healthy Steps model, an evidence-based approach to support parent understanding of child development, and by Medical Legal Partnership|Boston to identify legal and social needs that may affect a child's health and development. The dulce family partner will reach infants and families through their routine health care visits during their first six months of life and provide them with support for unmet legal needs, screen infants for developmental problems, screen families for mental health problems, and improve families' knowledge of child development. Families will meet with the DFP at the initial visit, at their subsequent routine healthcare maintenance visits, and during home visits if they wish.

Families in the control group will receive safety education from a trained staff member on safe sleep and safe transportation, at two of their baby's routine well-child visits between 1 and 6 months of age.

Subjects will answer two sets of standard survey questions before and after intervention / control. The infant's electronic medical record will be reviewed up to the first year. This study will test whether the project dulce intervention promotes positive outcomes for children and families, and reduces risks and adverse outcomes. The results of this rigorous program evaluation may be used to support dissemination of project dulce to other primary care sites throughout the country.

PROJECT GOALS 1. Assess whether the highly-structured dulce intervention results in:

improved individual and family strengths, reduced risks, and decreased likelihood of child maltreatment. 2. Provide system-level information to assess the costs, resource needs, barriers, and benefits that come from implementing the dulce model within a patient-centered medical home. 3. In addition to the project's research goals, we will collect aggregated Child Protective Service (CPS) community-wide data regarding childhood injury and maltreatment, as is requested by funder. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Abuse
• Child Development
• Child Neglect
• Child Rearing
• Parenting

• NCT number: NCT01343940
• Study type: Interventional
• Source: Boston Medical Center
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2011
• Completion date: June 2013