Promoting Early School Readiness in Primary Health Care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00212576
First received: September 19, 2005
Last updated: June 21, 2016
Last verified: June 2016
  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:

  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
Behavioral: Video Interaction Project
Behavioral: Building Blocks Project

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Discipline assessed using the Discipline Survey [ Time Frame: 6, 14, 24, 36, 54 mos and in 1st grade ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Will assess cognitive development

  • Woodcock-Johnson III Tests of Cognitive Abilities [ Time Frame: 14, 24, and 36 mos ] [ Designated as safety issue: No ]
    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).


Enrollment: 675
Study Start Date: November 2005
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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: 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.

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.
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.

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.
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.

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.
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.


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. 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.

  Eligibility

Ages Eligible for Study:   35 Weeks and older   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Alan L Mendelsohn, MD New York University School of Medicine
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00212576     History of Changes
Other Study ID Numbers: 12582  2R01HD047740-05 
Study First Received: September 19, 2005
Last Updated: June 21, 2016
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 August 24, 2016