Language Development Clinical Trial
— TMP-HV RCTOfficial title:
Treinta Millones de Palabras-Visitas al Hogar Pilot Randomized Controlled Trial
NCT number | NCT03076268 |
Other study ID # | 16-1579 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2, 2017 |
Est. completion date | August 29, 2019 |
Verified date | May 2023 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Treinta Millones de Palabras- Visitas al Hogar (TMP) is designed to intervene upon mothers' knowledge, beliefs, and behavior, which in turn influences their interaction with their children, impacting children's development. The investigators will measure change in mothers' knowledge, beliefs, and behavior during and after intervention, and measure impacts on children's development across major developmental domains. Specifically, the investigators will measure mothers' 1. Knowledge of child language development and the role of parents in that development 2. Beliefs about the malleability of intelligence and their role in shaping their children's intelligence 3. Interaction with their child, specifically their linguistic input and responsiveness to their child's communication Concurrently, the investigators will measure children's 1. Emergent oral language development, in both Spanish and English 2. Social-emotional development 3. Math and spatial reasoning skill development
Status | Completed |
Enrollment | 91 |
Est. completion date | August 29, 2019 |
Est. primary completion date | August 29, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - participants (i.e. parents and their children) who live at or below 200% of the federal poverty line, - female caregivers with a child between the ages of 24-30 months old, - participants whose preferred home language is Spanish, - education level is less than or equal to a bachelor's degree. Exclusion Criteria: - participants (i.e. parents and their children) who live over 200% of the federal poverty line, - parents under the age of 18, - non-female primary care giver - children younger than 24 months old or older than 30 months old (at start of study), - parents who do not have legal custody of their child, - parents whose child does not live with them, - parents who are not with their child at least two full days per week, - parents who are unable to commit to the intervention requirements, - foster parents, - children with significant cognitive or physical impairments, (specifically Autism Spectrum Disorder, Epilepsy, Cerebral Palsy, hearing impairment, Down Syndrome and blindness), - parents who have earned or are currently working toward a graduate or professional degree (e.g. M.A., M.S., M.B.A), and - parents whose preferred home language is not Spanish. |
Country | Name | City | State |
---|---|---|---|
United States | Thirty Million Words® Initiative at the University of Chicago Medicine | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Suskind DL, Leffel KR, Graf E, Hernandez MW, Gunderson EA, Sapolich SG, Suskind E, Leininger L, Goldin-Meadow S, Levine SC. A parent-directed language intervention for children of low socioeconomic status: a randomized controlled pilot study. J Child Lang. 2016 Mar;43(2):366-406. doi: 10.1017/S0305000915000033. Epub 2015 Jun 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline LENA scores in Adult Word Count, Conversational Turn Count, and Child Vocalizations in month 12, data aggregated by treatment group. | Baseline, 12 months | ||
Secondary | Change from baseline in parent knowledge about child development using the SPEAK survey in month 12, data aggregated by treatment group. | Baseline, 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03268928 -
Evaluating the Impact of Story Starters on Children's Language Development
|
N/A | |
Active, not recruiting |
NCT04919343 -
Do Video Materials Help Parents to Support Infant Development?
|
N/A | |
Recruiting |
NCT06026124 -
Retrieval-Based Word Learning in Developmental Language Disorder During Book Reading
|
N/A | |
Completed |
NCT02853786 -
Language Environment in Children With Cochlear Implants
|
N/A | |
Recruiting |
NCT02998164 -
Improving Outcomes Using Technology for Children Who Are DHH
|
N/A | |
Recruiting |
NCT04857255 -
Technology-assisted Language Intervention (TALI)
|
N/A | |
Active, not recruiting |
NCT04609553 -
Literacy Promotion for Latinos Study
|
N/A | |
Active, not recruiting |
NCT05339464 -
Ready and Healthy for Kindergarten
|
N/A | |
Completed |
NCT03795454 -
Can Singing Kangaroo Improve Outcome of Preterm Infants
|
N/A | |
Active, not recruiting |
NCT05325333 -
Retrieval-Based Word Learning in Developmental Language Disorder
|
N/A | |
Recruiting |
NCT06125093 -
Study of an Early Parenting Intervention for Children With Genetic Abnormalities and Mental Health Problems
|
N/A | |
Recruiting |
NCT06261307 -
Language Development Deficits and Early Interactive Music Intervention
|
N/A | |
Completed |
NCT06001866 -
Retrieval-Based Word Learning in Developmental Language Disorder: Verb Learning
|
N/A | |
Completed |
NCT03766906 -
STEM (Science, Technology, Engineering & Math) Familia Talk
|
N/A | |
Active, not recruiting |
NCT05508282 -
Testing an App-Based Approach to Reading and Screen Time Guidance for Parents of Infants
|
N/A | |
Completed |
NCT04027673 -
Thirty Million Words-Early Childhood Educator (TMW-ECE)
|
N/A | |
Completed |
NCT04423133 -
Bilingual Family Literacy Program Pilot
|
N/A | |
Not yet recruiting |
NCT05861531 -
Learning to Talk, Learning to Eat: A Randomized Controlled Trial to Improve NICU Oral Feeding and Language Outcomes
|
N/A | |
Completed |
NCT02774356 -
Testing Native Language Neural Commitment at the Subcortical Level
|
N/A | |
Completed |
NCT03547492 -
Developmental Intervention for Infants of Adolescent Mothers
|
N/A |