Strengthening Families and Reducing Risk Thru Developmental and Legal Collaboration

NCT01343940 | Completed Phase 2 DMC

• 1 other identifier: H-29958
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parenting; Child Rearing; Child Abuse; Child Neglect; Child Development

Keywords

RCT; randomized block repeated measures design; efficacy trial; high risk population

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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.

  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

  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.

  t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later

Study Arms (2)

Dulce family partner intervention

EXPERIMENTAL

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

Safety intervention

ACTIVE COMPARATOR

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

Interventions

Project dulce BEHAVIORAL

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

Dulce family partner intervention

Safety intervention BEHAVIORAL

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.

Safety intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• Center for the Study of Social Policy: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02127, United States

Location

Related Publications (2)

• Sege R, Preer G, Morton SJ, Cabral H, Morakinyo O, Lee V, Abreu C, De Vos E, Kaplan-Sanoff M. Medical-Legal Strategies to Improve Infant Health Care: A Randomized Trial. Pediatrics. 2015 Jul;136(1):97-106. doi: 10.1542/peds.2014-2955. Epub 2015 Jun 1.

  PMID: 26034248 RESULT

• Sege R., Kaplan-Sanoff M., Morton S., Velasco-Hodgson M.C., Preer G., Morakinyo G., De Vos E., Krathen J. Project DULCE: Strengthening families through enhanced primary care. The Journal of Zero to Three. Vol 35(1):10-18, September 2014.

  RESULT

Study Officials

• Robert D Sege, MD, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Edward De Vos, EdD

  William James College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HRIA Investigator

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: April 28, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: May 18, 2016

Record last verified: 2011-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)