This project will measure the degree to which parenting programs based in pediatric primary care can be effective in promoting language development and school readiness in at-risk young children.

The study is a randomized controlled trial in which two different primary care-based parenting programs will be compared to a control group in a population that is at risk on the basis of poverty. The two programs represent varying levels of low intensity, but each has the same goals: enhancing parent-child interaction in order to improve language, cognitive and social-emotional development and ultimately promote school readiness and school performance.

One program is called the "Video Interaction Project". While waiting to see the primary care provider for well child care, the family meets with a child development specialist, who videotapes the parent and infant interacting together. The videotape is then rewound and watched together by the parent (and infant!) and child development specialist. This leads to a discussion about child development, infant cues and parenting, with the child development specialist building on observed strengths in the interaction. In addition, families are provided with parenting pamphlets developed for the project, and with inexpensive developmentally stimulating toys.

The other program is called the "ASQ-Building Blocks Project". This project employs a public health approach to facilitate parental engagement in child development. Families are sent monthly newsletters that focus on child development, infant cues and parenting; included with each newsletter is an inexpensive, developmentally stimulating toy. In addition, families periodically receive Ages and Stages Questionnaires, which they complete and mail back to the program. Based on the questionnaires, the program determines whether the infant has screened positive for possible developmental delay and provides this information to both the family and the primary care provider.

This study will test 2 hypotheses:

1. Primary care based parenting interventions can impact parent-child interaction, early child development and school readiness.
2. Interventions of differing intensity will have impacts of differing magnitude depending on the risk level of the family.

Condition	Intervention
Language Development Disorders	Behavior: Video Interaction Project  Behavior: Building Blocks Project

Further Study Details: 

Primary Outcomes: Parent-child interaction; Parenting behaviors - reading aloud, play, verbal responsivity, engagement; Cognitive Development; Language Development; Social-emotional Development; Literacy Development; School Readiness
Secondary Outcomes: Need for developmental services (early intervention, special education); Media exposure; Feeding behaviors; Nutritional status / obesity
Expected Total Enrollment:  675

This project will measure the degree to which parenting programs based in pediatric primary care can be effective in promoting language development and school readiness in at-risk young children. The study will represent a collaboration between the Department of Pediatrics at New York University School of Medicine – Bellevue Hospital Center, the Medical and Health Research Association of New York City, Inc., and the Center for Research on Culture, Development and Education at New York University Steinhardt School of Education. Funding has been provided for 4 years, with total costs $1.98 million.

The study is a randomized controlled trial in which two different primary care-based parenting programs will be compared to a control group in a population that is at risk on the basis of poverty. The two programs represent varying levels of low intensity, but each has the same goals: enhancing parent-child interaction in order to improve language, cognitive and social-emotional development and ultimately promote school readiness and school performance.

One program is called the "Video Interaction Project". While waiting to see the primary care provider for well child care, the family meets with a child development specialist, who videotapes the parent and infant interacting together. The videotape is then rewound and watched together by the parent (and infant!) and child development specialist. This leads to a discussion about child development, infant cues and parenting, with the child development specialist building on observed strengths in the interaction. In addition, families are provided with parenting pamphlets developed for the project, and with inexpensive developmentally stimulating toys.

The other program is called the "ASQ-Building Blocks Project". This project employs a public health approach to facilitate parental engagement in child development. Families are sent monthly newsletters that focus on child development, infant cues and parenting; included with each newsletter is an inexpensive, developmentally stimulating toy. In addition, families periodically receive Ages and Stages Questionnaires, which they complete and mail back to the program. Based on the questionnaires, the program determines whether the infant has screened positive for possible developmental delay and provides this information to both the family and the primary care provider.

The study will take place at Bellevue Hospital Center, a public hospital serving low socioeconomic status families from throughout New York City. Infant-mother dyads will be enrolled during the postpartum period and followed through age 2 years. Periodic assessments will be performed of parent-child interaction and child developmental outcome. Dr. Mendelsohn will be seeking additional funding to continue the interventions and assessments for 3 to 5 additional years, with a goal of assessing the impact of these programs on school readiness.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Intention to receive primary care in the well-child clinic (FCC or newborn clinic) at Bellevue Hospital Center.
• Intention to remain in the New York City area for at least 3 years.
• Primary caregiver’s language is English or Spanish.
• Birthweight 2000gm or higher
• Gestational age 35 weeks or higher

Exclusion Criteria:

• Significant newborn medical complication
• Significant congenital anomaly or syndrome

Please refer to this study by ClinicalTrials.gov identifier  NCT00212576

Alan L Mendelsohn, MD      212-562-6342  Ext. 6342    alm5@nyu.edu
Samantha B Berkule, PhD      212-562-2522  Ext. 2522    samantha.berkule@med.nyu.edu

New York
      New York University School of Medicine, New York,  New York,  10016,  United States

Study chairs or principal investigators

Alan L Mendelsohn, MD,  Principal Investigator,  New York University School of Medicine   

Study ID Numbers:  The BELLE Project; 1 R01 HD47740-01A1
Last Updated:  September 20, 2005
Record first received:  September 19, 2005
ClinicalTrials.gov Identifier:  NCT00212576
Health Authority: United States: New York University School of Medicine Institutional Board of Research Associates; United States: National Institute of Child Health and Human Development
ClinicalTrials.gov processed this record on 2005-09-27