Strengthening Families and Reducing Risk Thru Developmental and Legal Collaboration (dulce)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Boston Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Quality Improvement Center- Early Childhood
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01343940
First received: March 16, 2011
Last updated: April 27, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Parenting
Child Rearing
Child Abuse
Child Neglect
Child Development
Behavioral: Project dulce
Behavioral: Safety intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Project Dulce: Developmental Understanding and Legal Collaboration for Everyone

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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" [ Time Frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later ] [ Designated as safety issue: No ]
    Paper-and-pencil questionnaire completed by child's caregiver

  • 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 [ Time Frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later ] [ Designated as safety issue: No ]
    Paper-and-pencil questionnaire completed by child's caregiver

  • 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" [ Time Frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in parental stress at 6 months, as measured by the "Parenting Stress Index (PSI) - long form" [ Time Frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later ] [ Designated as safety issue: No ]
    Paper-and-pencil instrument completed by child's caregiver

  • 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)" [ Time Frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later ] [ Designated as safety issue: No ]
    Paper-and-pencil instrument completed by child's caregiver; 40 Likert-type items.


Estimated Enrollment: 480
Study Start Date: February 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dulce family partner 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.
Behavioral: Project dulce
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.
Other Names:
  • dulce
  • dulce family partner
Active Comparator: Safety intervention
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 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.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The patient family must include an infant, or infants for families with multiples, born 10 weeks or less prior to recruitment.
  • The newborn(s) must be healthy, having been born without known defects or complications that would require early hospitalization.
  • The infant must have been discharged from hospital within one week.
  • At the time of recruitment, the parent/guardian will have communicated their intent to obtain their newborn infant's primary pediatric care through Boston Medical Center's (BMC's) Primary Pediatric Care Clinic (PPCC).
  • The child's parent/guardian must be able to engage in an informed consent process conducted in English or Spanish.
  • The child's parent/guardian must be able to complete a questionnaire and/or interview (with or without assistance) in English or Spanish.

Exclusion Criteria:

  • The participating parent/guardian is under 18 years of age. As SOC at BMC, mothers under the age of 18 are seen in the The Teen and Tot Program (TTP), a specialized program located within BMC's Adolescent Center.
  • The parent/guardian is unable to participate in required data collection activities in the study languages, even with assistance.
  • The child/family's physician believes that participation in the evaluation would adversely affect the child/family's health or well being or the ongoing delivery of health care services. Decision will be made based on the physician's clinical judgment. All physicians have the opportunity to opt their patients out.
  • The family is already receiving services from another family partner program such as Project RISE, Healthy Steps, etc. through the BMC primary care center.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343940

Contacts
Contact: Edward De Vos, EdD 617-414-6369 eddevos@bu.edu
Contact: Robert D Sege, MD, PhD 617-414-2793 robert.sege@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02127
Contact: Robert Sege, MD, PhD    617-414-2793    robert.sege@bmc.org   
Contact: Louisa Sullivan, BA    617-414-7425    louisa.sullivan@bmc.org   
Sub-Investigator: Oluwatomisin Grace Morakinyo         
Sponsors and Collaborators
Boston Medical Center
Quality Improvement Center- Early Childhood
Investigators
Principal Investigator: Robert D Sege, MD, PhD Boston University
Study Director: Edward De Vos, EdD Boston University
  More Information

No publications provided

Responsible Party: Robert Sege, MD PhD, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01343940     History of Changes
Other Study ID Numbers: H-29958
Study First Received: March 16, 2011
Last Updated: April 27, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Boston Medical Center:
RCT
randomized block repeated measures design
efficacy trial
high risk population

ClinicalTrials.gov processed this record on August 20, 2014