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Sponsors and Collaborators: |
New York University School of Medicine National Institutes of Health (NIH) |
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Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00212576 |
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:
Condition | Intervention |
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Language Development Disorders |
Behavioral: Video Interaction Project Behavioral: Building Blocks Project |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Promoting Early School Readiness in Primary Health Care |
Estimated Enrollment: | 675 |
Study Start Date: | November 2005 |
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: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alan L Mendelsohn, MD | 212-562-6342 ext 6342 | alm5@nyu.edu |
Contact: Samantha B Berkule, PhD | 212-562-2522 ext 2522 | samantha.berkule@med.nyu.edu |
United States, New York | |
New York University School of Medicine | Recruiting |
New York, New York, United States, 10016 | |
Sub-Investigator: Harris S Huberman, MD | |
Sub-Investigator: Benard P Dreyer, MD |
Principal Investigator: | Alan L Mendelsohn, MD | New York University School of Medicine |
Study ID Numbers: | The BELLE Project, 1 R01 HD47740-01A1 |
Study First Received: | September 19, 2005 |
Last Updated: | November 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00212576 History of Changes |
Health Authority: | United States: Institutional Review Board |
Child development Language Development Parenting |
Signs and Symptoms Language Development Disorders Neurologic Manifestations |
Language Disorders Neurobehavioral Manifestations Communication Disorders |
Signs and Symptoms Nervous System Diseases Language Development Disorders Neurologic Manifestations |
Language Disorders Neurobehavioral Manifestations Communication Disorders |