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Promoting Early School Readiness in Primary Health Care

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212576
First Posted: September 21, 2005
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
New York University School of Medicine
September 19, 2005
September 21, 2005
February 24, 2017
November 2005
December 2017   (Final data collection date for primary outcome measure)
  • Discipline assessed using the Discipline Survey [ Time Frame: 6, 14, 24, 36, 54 mos and in 1st grade ]
    Discipline mediates effects of poverty on social-emotional outcomes (Gershoff, 2007), and attitudes about discipline practices form early in children's lives (Socolar, 1996).
  • Stress related to interactions and lack of warmth will be assessed using The Parenting Stress Index - Short Form (PSI) [ Time Frame: 6, 14, 24, 36, 54 mos and in 1st grade ]
    Stress related to interactions and lack of warmth mediate effects of poverty on emotional outcomes.
  • Bayley Scales of Infant and Toddler Development [ Time Frame: 14, 24, and 36 mos ]
    Will assess cognitive development
  • Woodcock-Johnson III Tests of Cognitive Abilities [ Time Frame: 14, 24, and 36 mos ]
    Will be used to estimate child's cognitive. Four sub-tests will be used: Verbal comprehension (VC) assesses the comprehension knowledge Cattell-Horn-Carroll cognitive factor (Gc); Memory for Words and Auditory Working Memory assess the short term memory CHC factor (Gsm); Visual Matching measures the CHC processing speed factor (Gs).
  • Parent-child interaction
  • Parenting behaviors - reading aloud, play, verbal responsivity, engagement
  • Cognitive Development
  • Language Development
  • Social-emotional Development
  • Literacy Development
  • School Readiness
Complete list of historical versions of study NCT00212576 on ClinicalTrials.gov Archive Site
Not Provided
  • Need for developmental services (early intervention, special education)
  • Media exposure
  • Feeding behaviors
  • Nutritional status / obesity
Not Provided
Not Provided
 
Promoting Early School Readiness in Primary Health Care
Promoting Early School Readiness in Primary Health Care

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.

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. Initial funding was provided by NICHD for 4 years. NICHD provided 5 additional years of competing renewal funding beginning in July, 2010.

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.

At age 3 years, VIP and control families were re-randomized to receive either additional VIP from age 3 to 5 years or to control during that period. This factorial design will allow for assessment of dose and timing in relation to outcomes.

We further plan to follow children into school, so that we can assess long-term educational outcomes including standardized test scores. Should long-term funding be obtained, we will follow children through high school to assess intervention impacts on graduation rates.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Language Development Disorders
  • Behavioral: 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.
  • Behavioral: 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.
  • Experimental: Building Blocks (0-3)

    Randomized at birth to receive Building Blocks Project from birth through 3 years of age.

    Note: This arm not followed past 3 years of age; NOT re-randomized to any group at age 3.

    Intervention: Behavioral: Building Blocks Project
  • Experimental: VIP (0-3), VIP (3-5)

    Randomized at birth to receive Video Interaction Project from birth through 3 years of age.

    Re-randomized at 3 years to receive Video Interaction Project from 3-5 years of age.

    Intervention: Behavioral: Video Interaction Project
  • Experimental: VIP (0-3), Control (3-5)

    Randomized at birth to receive Video Interaction Project from birth through 3 years of age.

    Re-randomized at 3 years to receive care as usual (control) from 3-5 years of age.

    Intervention: Behavioral: Video Interaction Project
  • Experimental: Control (0-3), VIP (3-5)

    Randomized at birth to receive care as usual (control) from birth through 3 years of age.

    Re-randomized at 3 years to receive Video Interaction Project from 3-5 years of age.

    Intervention: Behavioral: Video Interaction Project
  • No Intervention: Control (0-3), Control (3-5)

    Randomized at birth to receive care as usual (control) from birth through 3 years of age.

    Re-randomized at 3 years to receive receive care as usual (control) from 3-5 years of age.


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
675
January 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Weeks and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00212576
12582
2R01HD047740-05 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
New York University School of Medicine
New York University School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Alan L Mendelsohn, MD New York University School of Medicine
New York University School of Medicine
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP