Overview

This trial is active, not recruiting.

Condition language development disorders
Treatments video interaction project, building blocks project
Sponsor New York University School of Medicine
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date November 2005
End date January 2017
Trial size 675 participants
Trial identifier NCT00212576, 12582, 2R01HD047740-05

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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.
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)
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.
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)
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.
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)
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.
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)
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.

Primary Outcomes

Measure
Discipline assessed using the Discipline Survey
time frame: 6, 14, 24, 36, 54 mos and in 1st grade
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
Bayley Scales of Infant and Toddler Development
time frame: 14, 24, and 36 mos
Woodcock-Johnson III Tests of Cognitive Abilities
time frame: 14, 24, and 36 mos

Eligibility Criteria

Male or female participants at least 35 weeks old.

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

Additional Information

Official title Promoting Early School Readiness in Primary Health Care
Principal investigator Alan L Mendelsohn, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.