Language Development DisordersNCT00212576
Promoting Early School Readiness in Primary Health Care
A study testing Video Interaction Project and Building Blocks Project in people with Language Development Disorders, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Language Development Disorders
- What is being tested?
- Video Interaction Project and Building Blocks Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to 18 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant newborn medical complication
- Significant congenital anomaly or syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Language Development Disorders
- Being tested
- Video Interaction Project, Building Blocks Project
- Keywords
- Child development, Language Development, Parenting
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Interaction ProjectBehavioural
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 ProjectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6, 14, 24, 36, 54 mos and in 1st grade
Bayley Scales of Infant and Toddler Development
Will assess cognitive development
Measured: 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).
Measured: 14, 24, and 36 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2005
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Alan L Mendelsohn, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212576
- Sponsor's protocol ID
- 12582
- Other IDs
- 2R01HD047740-05
- Status last verified
- Nov 2019
- First submitted
- 19 Sep 2005
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15718881Mendelsohn 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.
PubMed 17565287Berkule 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.
PubMed 17261482Mendelsohn 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.
PubMed 18458186Berkule 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.
PubMed 18501863Green 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.
PubMed 19736337Weisleder 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.
PubMed 31399245Cates 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.
PubMed 29703577Mendelsohn 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.
PubMed 29632254Mendelsohn 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.
PubMed 21199979Mendelsohn 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.
PubMed 21199978
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Early School Readiness in Primary Health Care
- ClinicalTrials.gov ID
- NCT00212576
- Acronym / sponsor ID
- 12582
- Conditions
- Language Development Disorders
- Keywords
- Child development, Language Development, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2005 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Building Blocks (0-3) | Experimental | Behavioral: Building Blocks ProjectRandomized 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. |
| VIP (0-3), VIP (3-5) | Experimental | Behavioral: Video Interaction ProjectRandomized 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. |
| VIP (0-3), Control (3-5) | Experimental | Behavioral: Video Interaction ProjectRandomized 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. |
| Control (0-3), VIP (3-5) | Experimental | Behavioral: Video Interaction ProjectRandomized 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. |
| 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. |
Who may qualify
- Ages
- 35 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Significant newborn medical complication
- Significant congenital anomaly or syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Interaction ProjectWhile 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. | Behavioural | Control (0-3), VIP (3-5), VIP (0-3), Control (3-5), VIP (0-3), VIP (3-5) |
| Building Blocks ProjectThis 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. | Behavioural | Building Blocks (0-3) |
Primary outcome
Discipline assessed using the Discipline Survey
Time frame: 6, 14, 24, 36, 54 mos and in 1st grade
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
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
Will assess cognitive development
Woodcock-Johnson III Tests of Cognitive Abilities
Time frame: 14, 24, and 36 mos
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Background: PubMed 15718881Mendelsohn 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.
- Background: PubMed 17565287Mendelsohn 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.
- Background: PubMed 17261482Berkule 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.
- Background: PubMed 18458186Mendelsohn 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.
- Background: PubMed 18501863Berkule 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.
- Background: PubMed 19736337Green 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.
- Derived from this study: PubMed 31399245Weisleder 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.
- Derived from this study: PubMed 29703577Cates 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.
- Derived from this study: PubMed 29632254Mendelsohn 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.
- Derived from this study: PubMed 21199979Mendelsohn 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.
- Derived from this study: PubMed 21199978Mendelsohn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan L Mendelsohn, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Interaction Project and Building Blocks Project in people with Language Development Disorders, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discipline assessed using the Discipline Survey (time frame: 6, 14, 24, 36, 54 mos and in 1st grade). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212576, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.