Promoting Early School Readiness in Primary Health Care - Full Text View

Sponsor:	New York University School of Medicine
Collaborator:	National Institutes of Health (NIH)
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00212576

Purpose

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:

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Promoting Early School Readiness in Primary Health Care

Resource links provided by NLM:

MedlinePlus related topics: Child Development Drug Reactions Infant and Newborn Development Parenting Toddler Development

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Parent-child interaction [ Designated as safety issue: No ]
Parenting [ Designated as safety issue: No ]
Cognitive Development [ Designated as safety issue: No ]
Language Development [ Designated as safety issue: No ]
Social-emotional Development [ Designated as safety issue: No ]
Literacy Development [ Designated as safety issue: No ]
School Readiness [ Designated as safety issue: No ]

Secondary Outcome Measures:

Need for developmental services (early intervention, special education) [ Designated as safety issue: No ]
Media exposure [ Designated as safety issue: No ]
Feeding behaviors [ Designated as safety issue: No ]
Nutritional status / obesity [ Designated as safety issue: No ]

Enrollment:	675
Study Start Date:	November 2005

Detailed Description:

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.

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 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212576

Locations

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

Sponsors and Collaborators

New York University School of Medicine

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Alan L Mendelsohn, MD

New York University School of Medicine

More Information

Publications:

Mendelsohn AL, Dreyer BP, Flynn V, Tomopoulos S, Rovira I, Tineo W, Pebenito C, Torres C, Torres H, Nixon AF. Use of videotaped interactions during pediatric well-child care to promote child development: a randomized, controlled trial. J Dev Behav Pediatr. 2005 Feb;26(1):34-41.

Mendelsohn AL, Valdez PT, Flynn V, Foley GM, Berkule SB, Tomopoulos S, Fierman AH, Tineo W, Dreyer BP. Use of videotaped interactions during pediatric well-child care: impact at 33 months on parenting and on child development. J Dev Behav Pediatr. 2007 Jun;28(3):206-12.

Berkule SB, Dreyer BP, Huberman HS, Fierman AH, Mendelsohn AL. Attitudes about shared reading among at-risk mothers of newborn babies. Ambul Pediatr. 2007 Jan-Feb;7(1):45-50.

Mendelsohn AL, Berkule SB, Tomopoulos S, Tamis-LeMonda CS, Huberman HS, Alvir J, Dreyer BP. Infant television and video exposure associated with limited parent-child verbal interactions in low socioeconomic status households. Arch Pediatr Adolesc Med. 2008 May;162(5):411-7.

Berkule SB, Dreyer BP, Klass PE, Huberman HS, Yin HS, Mendelsohn AL. Mothers' expectations for shared reading after delivery: implications for reading activities at 6 months. Ambul Pediatr. 2008 May-Jun;8(3):169-74. Epub 2008 Apr 8.

Green CM, Berkule SB, Dreyer BP, Fierman AH, Huberman HS, Klass PE, Tomopoulos S, Yin HS, Morrow LM, Mendelsohn AL. Maternal literacy and associations between education and the cognitive home environment in low-income families. Arch Pediatr Adolesc Med. 2009 Sep;163(9):832-7.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mendelsohn AL, Dreyer BP, Brockmeyer CA, Berkule-Silberman SB, Huberman HS, Tomopoulos S. Randomized controlled trial of primary care pediatric parenting programs: effect on reduced media exposure in infants, mediated through enhanced parent-child interaction. Arch Pediatr Adolesc Med. 2011 Jan;165(1):42-8.

Mendelsohn AL, Huberman HS, Berkule SB, Brockmeyer CA, Morrow LM, Dreyer BP. Primary care strategies for promoting parent-child interactions and school readiness in at-risk families: the Bellevue Project for Early Language, Literacy, and Education Success. Arch Pediatr Adolesc Med. 2011 Jan;165(1):33-41.

Responsible Party:	Alan L. Mendelsohn, MD, NYUmed
ClinicalTrials.gov Identifier:	NCT00212576 History of Changes
Other Study ID Numbers:	The BELLE Project, 2R01HD047740-05
Study First Received:	September 19, 2005
Last Updated:	July 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

Child development
Language Development
Parenting

Additional relevant MeSH terms:

Language Development Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 13, 2012