NCT00212576

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:

  1. 1.Primary care based parenting interventions can impact parent-child interaction, early child development and school readiness.
  2. 2.Interventions of differing intensity will have impacts of differing magnitude depending on the risk level of the family.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
675

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2017

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

12.1 years

First QC Date

September 19, 2005

Last Update Submit

November 27, 2019

Conditions

Language Development Disorders

Keywords

Child developmentLanguage DevelopmentParenting

Outcome Measures

Primary Outcomes (4)

  • 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).

    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)

    Stress related to interactions and lack of warmth mediate effects of poverty on emotional outcomes.

    6, 14, 24, 36, 54 mos and in 1st grade

  • Bayley Scales of Infant and Toddler Development

    Will assess cognitive development

    14, 24, and 36 mos

  • 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).

    14, 24, and 36 mos

Study Arms (5)

Building Blocks (0-3)

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.

Behavioral: Building Blocks Project

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

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.

Behavioral: Video Interaction Project

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

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.

Behavioral: Video Interaction Project

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

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.

Behavioral: Video Interaction Project

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

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.

Interventions

Video Interaction ProjectBEHAVIORAL

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)VIP (0-3), Control (3-5)VIP (0-3), VIP (3-5)
Building Blocks ProjectBEHAVIORAL

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.

Building Blocks (0-3)

Eligibility Criteria

Age35 Weeks+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant newborn medical complication
  • Significant congenital anomaly or syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (11)

  • 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.

    PMID: 15718881BACKGROUND

  • 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.

    PMID: 17565287BACKGROUND

  • 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.

    PMID: 17261482BACKGROUND

  • 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.

    PMID: 18458186BACKGROUND

  • 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.

    PMID: 18501863BACKGROUND

  • 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.

    PMID: 19736337BACKGROUND

  • 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.

    PMID: 31399245DERIVED

  • 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.

    PMID: 29703577DERIVED

  • 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.

    PMID: 29632254DERIVED

  • 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.

    PMID: 21199979DERIVED

  • 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.

    PMID: 21199978DERIVED

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alan L Mendelsohn, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 21, 2005

Study Start

November 1, 2005

Primary Completion

December 18, 2017

Study Completion

December 18, 2017

Last Updated

November 29, 2019

Record last verified: 2019-11

Locations

US(1)