A Phase 2/3 interventional study of Project dulce and Safety intervention in Parenting, Child Rearing and Child Abuse, sponsored by Boston Medical Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2016-05-18.
Sponsored by Boston Medical Center · Phase 2/3, Interventional, and Prevention
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.
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.
Boston Medical Center is the lead sponsor of 314 studies on the registry; 34 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participating families are assigned to a legal/developmental specialist who joins health care team during well-child visits and home visits. The specialist (a "Dulce family partner") supports parent around child development issues, addresses unmet basic needs (e.g., housing, utilities, food, etc.), and makes referral to existing agencies and services.
Behavioral: Project dulce
Participating family is assigned a safety specialist who will provide the parent with guidance, equipment and instruction to reduce risk of newborn injury during transport (car seat) and while sleeping (Pack-and-Play).
Behavioral: Safety intervention
Participating families are assigned to a legal/developmental specialist who joins health care team during well-child visits and home visits. The specialist (a "Dulce family partner") supports parent around child development issues, addresses unmet basic needs (e.g., housing, utilities, food, etc.), and makes referral to existing agencies and services. Specialist meets with family during all routine well-child visits scheduled in primary care between birth and 6 months (1-mo, 2-mo, 4-mo, 6-mo). Parent may meet with specialist before or after scheduled appointment, and may request a home visit. Specialist will be available by phone for consultation.
Also known as: dulce, dulce family partner
Participating family is assigned a safety specialist. Meeting with the safety specialist will occur before or after a routine well-child visit or at a separately agreed upon time. The specialist will discuss infant injury risks associated with transportation and sleep. The specialist will provide safety equipment (car seat and pack-and-play) and instruct the parent in their proper use.
Change from baseline in number of child maltreatment protective factors available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Caregivers Assessment of Protective Factors"
Paper-and-pencil questionnaire completed by child's caregiver
Time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Change from baseline in number and amount of income supports available to and accessed by caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Self-Report Family Inventory" + supplementary questions on $ value
Paper-and-pencil questionnaire completed by child's caregiver
Time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Change from baseline in social capital available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Social Network Grid"
Paper-and-pencil questionnaire completed by child's caregiver working with reasearch interviewer. Adapted from: Tracy, EM \& Whittaker, JK (1990). The Social Network Map: Assessing social support in clinical social work practice. Families in Society, 71(8), 461-470.
Time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Change from baseline in parental stress at 6 months, as measured by the "Parenting Stress Index (PSI) - long form"
Paper-and-pencil instrument completed by child's caregiver
Time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Change from baseline in parenting and child-rearing attitudes of child's caregiver at 6 months, as measured on the "Adult-Adolescent Parenting Inventory(AAPI-2)"
Paper-and-pencil instrument completed by child's caregiver; 40 Likert-type items.
Time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Plan to share: No
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Boston Medical Center