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Promoting Early School Readiness in Primary Health Care

Primary Purpose

Language Development Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Interaction Project
Building Blocks Project
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Language Development Disorders focused on measuring Child development, Language Development, Parenting

Eligibility Criteria

35 Weeks - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Building Blocks (0-3)

VIP (0-3), VIP (3-5)

VIP (0-3), Control (3-5)

Control (0-3), VIP (3-5)

Control (0-3), Control (3-5)

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Discipline assessed using the Discipline Survey
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)
Stress related to interactions and lack of warmth mediate effects of poverty on emotional outcomes.
Bayley Scales of Infant and Toddler Development
Will assess cognitive development
Woodcock-Johnson III Tests of Cognitive Abilities
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).

Secondary Outcome Measures

Full Information

First Posted
September 19, 2005
Last Updated
November 27, 2019
Sponsor
NYU Langone Health
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00212576
Brief Title
Promoting Early School Readiness in Primary Health Care
Official Title
Promoting Early School Readiness in Primary Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 2005 (Actual)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
December 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Development Disorders
Keywords
Child development, Language Development, Parenting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
675 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Building Blocks (0-3)
Arm Type
Experimental
Arm Description
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.
Arm Title
VIP (0-3), VIP (3-5)
Arm Type
Experimental
Arm Description
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.
Arm Title
VIP (0-3), Control (3-5)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (0-3), VIP (3-5)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (0-3), Control (3-5)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video Interaction Project
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Building Blocks Project
Intervention Description
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.
Primary Outcome Measure Information:
Title
Discipline assessed using the Discipline Survey
Description
Discipline mediates effects of poverty on social-emotional outcomes (Gershoff, 2007), and attitudes about discipline practices form early in children's lives (Socolar, 1996).
Time Frame
6, 14, 24, 36, 54 mos and in 1st grade
Title
Stress related to interactions and lack of warmth will be assessed using The Parenting Stress Index - Short Form (PSI)
Description
Stress related to interactions and lack of warmth mediate effects of poverty on emotional outcomes.
Time Frame
6, 14, 24, 36, 54 mos and in 1st grade
Title
Bayley Scales of Infant and Toddler Development
Description
Will assess cognitive development
Time Frame
14, 24, and 36 mos
Title
Woodcock-Johnson III Tests of Cognitive Abilities
Description
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).
Time Frame
14, 24, and 36 mos

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan L Mendelsohn, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15718881
Citation
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.
Results Reference
background
PubMed Identifier
17565287
Citation
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.
Results Reference
background
PubMed Identifier
17261482
Citation
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.
Results Reference
background
PubMed Identifier
18458186
Citation
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.
Results Reference
background
PubMed Identifier
18501863
Citation
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.
Results Reference
background
PubMed Identifier
19736337
Citation
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.
Results Reference
background
PubMed Identifier
31399245
Citation
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.
Results Reference
derived
PubMed Identifier
29703577
Citation
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.
Results Reference
derived
PubMed Identifier
29632254
Citation
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.
Results Reference
derived
PubMed Identifier
21199979
Citation
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.
Results Reference
derived
PubMed Identifier
21199978
Citation
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.
Results Reference
derived

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Promoting Early School Readiness in Primary Health Care

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