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Text Message Reminders + Literacy Promotion for Childhood Language Development
N/A
Waitlist Available
Led By Manuel E Jimenez, MD, MS
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9-month follow-up, 18-month follow-up
Awards & highlights
Study Summary
This trial will test if text messages reminding parents to help their children with learning activities, combined with standard help for improving literacy skills, can improve language and social skills among poor Latino kids.
Who is the study for?
This study is for Latino/a/x primary caregivers, aged 18 or older, who speak English or Spanish and own a cell phone. They must care for a child between 6-12 months old and be willing to receive texts and join one of three study groups. It's not for those planning to leave their pediatric clinic soon, unable to consent, or with children having certain congenital/genetic disorders.Check my eligibility
What is being tested?
The trial examines if special text messages combined with access to resources that reduce poverty can boost language and social skills in low-income Latino children when added to standard literacy promotion in primary care.See study design
What are the potential side effects?
Since the interventions involve educational text messages and connections to community resources rather than medical treatments, there are no direct physical side effects expected from participating in this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9-month follow-up, 18-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9-month follow-up, 18-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver discipline strategies
Change in caregiver cognitive stimulation
Change in child social-emotional skills
+3 moreSecondary outcome measures
Caregiver attitudes about reading
Change in caregiver-clinician relationship
Change in child media use
+3 moreOther outcome measures
Observed parent-child interactions
ROR receipt
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: ROR plus text messages plus connection to community resourcesExperimental Treatment3 Interventions
In addition to ROR and text messages, participants will be referred to a county-based single point of entry system for referrals to community resources. This system simplifies access to poverty-reducing resources by creating a centralized access point, maintaining an updated data base of resources with existing capacity to support families, and providing case management.
Group II: ROR plus text messagesExperimental Treatment2 Interventions
In addition to ROR, participants will receive three text messages per week, plus one interactive follow-up message per month, for the study period with scheduled breaks.
Group III: Usual care including RORActive Control1 Intervention
Literacy promotion is a pediatric standard of care. Participants in this group will receive usual care that includes ROR, a primary care literacy promotion intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Text messages
2012
Completed Phase 2
~1260
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
63,602 Total Patients Enrolled
3 Trials studying Language Development
487 Patients Enrolled for Language Development
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,100 Total Patients Enrolled
Manuel E Jimenez, MD, MSPrincipal InvestigatorRutgers, The State University of New Jersey
3 Previous Clinical Trials
469 Total Patients Enrolled
2 Trials studying Language Development
455 Patients Enrolled for Language Development
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You own a cell phone.I am willing to be assigned to any of the study groups.I am 18 years old or older.My child has genetic disorders and developmental delays.I plan to stop receiving care at my current children's clinic.I am willing to receive text messages.I am the main caregiver for a baby aged 6 to 12 months.You self-identify as Latino/a/x.I am unable to understand or sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: ROR plus text messages plus connection to community resources
- Group 2: Usual care including ROR
- Group 3: ROR plus text messages
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What purpose does this trial intend to fulfill?
"This trial, to be evaluated over a nine-month and eighteen-month period respectively, aims to assess changes in communicative skills of children. Secondary objectives involve evaluating the Parent Reading Belief Inventory - which gauges affective attitudes and knowledge about reading with minors - as well as analyzing parenting stressors by means of caregiver reports on social needs and ScreenQ scores depicting media use among minors."
Answered by AI
Are more participants being sought for this investigation?
"Affirmative. The information found on clinicaltrials.gov verifies that this research is recruiting participants and has been since November 16th 2020. For the most recent update, refer to October 26th 2022 for further details about 630 patients needing to be enrolled from one medical centre."
Answered by AI
How many volunteers are being recruited for this trial?
"Yes, clinicaltrials.gov indicates that this trial is accepting patients. It was first posted on November 16th 2020 and has recently been updated as of October 26th 2022. The study will involve 630 participants across a single site."
Answered by AI
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