Promoting Early School Readiness in Primary Health Care
NCT ID: NCT00212576
Last Updated: 2019-11-29
Study Results
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Basic Information
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COMPLETED
NA
675 participants
INTERVENTIONAL
2005-11-30
2017-12-18
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 congenital anomaly or syndrome
35 Weeks
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Alan L Mendelsohn, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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References
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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. doi: 10.1097/DBP.0b013e3180324d87.
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. doi: 10.1016/j.ambp.2006.10.004.
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. doi: 10.1001/archpedi.162.5.411.
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. doi: 10.1016/j.ambp.2008.01.002. 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. doi: 10.1001/archpediatrics.2009.136.
Weisleder A, Cates CB, Harding JF, Johnson SB, Canfield CF, Seery AM, Raak CD, Alonso A, Dreyer BP, Mendelsohn AL. Links between Shared Reading and Play, Parent Psychosocial Functioning, and Child Behavior: Evidence from a Randomized Controlled Trial. J Pediatr. 2019 Oct;213:187-195.e1. doi: 10.1016/j.jpeds.2019.06.037. Epub 2019 Aug 6.
Cates CB, Weisleder A, Berkule Johnson S, Seery AM, Canfield CF, Huberman H, Dreyer BP, Mendelsohn AL. Enhancing Parent Talk, Reading, and Play in Primary Care: Sustained Impacts of the Video Interaction Project. J Pediatr. 2018 Aug;199:49-56.e1. doi: 10.1016/j.jpeds.2018.03.002. Epub 2018 Apr 24.
Mendelsohn AL, Cates CB, Weisleder A, Berkule Johnson S, Seery AM, Canfield CF, Huberman HS, Dreyer BP. Reading Aloud, Play, and Social-Emotional Development. Pediatrics. 2018 May;141(5):e20173393. doi: 10.1542/peds.2017-3393. Epub 2018 Apr 9.
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. doi: 10.1001/archpediatrics.2010.266.
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. doi: 10.1001/archpediatrics.2010.254.
Other Identifiers
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12582
Identifier Type: -
Identifier Source: org_study_id
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