STEM (Science, Technology, Engineering & Math) Familia Talk

February 6, 2023 updated by: Oregon Research Behavioral Intervention Strategies, Inc.

STEM Familia Talk: A Bilingual Language Acquisition Smart Speaker App to Improve Academic Vocabulary, Engagement and Long-term Education and Health Outcomes for Latino Students and Their Families

After development of the Talk Stem Familia (TSF) smart-speaker application prototype, the study will evaluate the prototype's efficacy in a within-subjects pre-post design study. The sample will contain 50 parent-student/child dyads who will use the Alexa skill app for 6 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will receive an Echo Dot device enabled with the application prototype using a research Amazon account created for each dyad. The Echo Dot devices will be preconfigured by project staff onto research Amazon accounts. Parents will come to one of several orientation sessions to obtain their device and set-up instructions; staff will provide follow-up phone support as needed. Usage data will show how much the device is used by each dyad. To ensure exposure to TSF, parents will be asked to engage at least 3 times per week; project staff will prompt parents bi-weekly (via text, email, device notification, phone) during the 6-week intervention to encourage usage and provide needed technical support.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Behavioral Intervention Strategies, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Latino parents and their children who are students in grades 3 through 6.
  • Parents have Spanish as primary home language.
  • Family has wi-fi in the home.
  • No age limits for parents. Their child must be in grades 3 through 6.

Exclusion Criteria:

  • Parents and their children who are students in grade levels below grade 3 or above grade 6.
  • Parents do not have Spanish as primary home language.
  • Family does not have wi-fi in the home.
  • Children younger than 8 (or in grade levels below grade 3).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Talk STEM Familia App
This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.
Behavioral: Talk STEM Familia app
The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Student Academic Vocabulary Knowledge in English
Time Frame: Baseline (pretest) and 6 weeks (posttest)
The Student Academic Vocabulary Knowledge in English measure includes 18 multiple choice questions on the 18 words taught in the TSF app. The student chooses the correct word meaning from among four (4) possible responses. Students receive one point for each word correctly identified and points are summed across the 18 items. Scores can range from 0-18 and a higher score indicates greater vocabulary knowledge.
Baseline (pretest) and 6 weeks (posttest)
Parent Academic Vocabulary Knowledge in Spanish
Time Frame: Baseline (pretest) and 6 weeks (posttest)
The Parent Academic Vocabulary Knowledge in Spanish measure includes 18 multiple choice questions on the 18 words taught in the TSF app. The parent chooses the correct word meaning from among four (4) possible responses. Parents receive one point for each word correctly identified and points are summed across the 18 items. Scores can range from 0-18 and a higher score indicates greater vocabulary knowledge.
Baseline (pretest) and 6 weeks (posttest)
Student Academic Vocabulary Usage in English
Time Frame: Baseline (pretest) and 6 weeks (posttest)
The Student Academic Vocabulary Usage in English measure includes 18 true/false questions testing student knowledge of correct usage of the 18 academic vocabulary words taught in the TSF app.
Baseline (pretest) and 6 weeks (posttest)
Parent Academic Vocabulary Usage in Spanish
Time Frame: Baseline (pretest) and 6 weeks (posttest)
The Parent Academic Vocabulary Usage in Spanish measure includes 18 true/false questions testing student knowledge of correct usage of the 18 academic vocabulary words taught in the TSF app.
Baseline (pretest) and 6 weeks (posttest)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Student Engagement Instrument
Time Frame: Baseline (pretest) and 6 weeks (posttest)
The Student Engagement Instrument (SEI; Betts, Appleton, Reschly, et al., 2010) consists of three subscales (future aspirations and goals, 5 items, r = .80, family support for learning, 6 items, r = .79, and control and relevance of school work, 9 items, r = 70). The SEI scale for each item ranges from 1-"Strongly disagree" to 5- "Strongly agree" with 5 indicating greater self-efficacy (more positive). A sum score was computed for each subscale. For future aspirations the scores can range from 5 to 25 and a higher score indicates a more positive outcome; greater self-efficacy for future aspirations. For family support for learning the score can range from 6 to 30 and a higher scores indicates a more positive outcome; greater self-efficacy for family support for learning. For control and relevance of school work the scores can range from 9 to 45 and a greater score indicates a more positive outcome; greater self-efficacy for control and relevance of school work.
Baseline (pretest) and 6 weeks (posttest)
The Efficacy to Influence School-related Performance Subscale of the Parental Self-Efficacy Scale
Time Frame: Baseline (pretest) and 6 weeks (posttest)
The Efficacy to Influence School-related Performance subscale of the Parental Self-Efficacy Scale (PSES; Bandura, et al., 2001) (completed in Spanish) to measure useful factors that reflect parents' perceptions of whether they can influence their child's academic performance. The PSES consists of 8 items on a 9-point scale ranging from 1 = "nothing" to 9 = "a great deal" . The measure has an internal reliability of .87. A mean composite score was computed and the scores can range from 1 to 9 with a higher score indicating a more positive outcome; greater levels of self-efficacy.
Baseline (pretest) and 6 weeks (posttest)
Student Academic Language Learning Behaviors
Time Frame: Baseline (pretest) and 6 weeks (posttest)
The Student Academic Language Learning Behaviors measure includes 11 items asking students to estimate the frequency of discrete learning behaviors such as saying "scientific" words out loud in English and using "scientific" words in sentences. The measure uses a 4-point scale of frequency with 1 being "Not at all" and 4 being " 3-4 times a week." A sum score for the 11 items was computed and the scores could range from 11 to 44. Higher scores indicate a more positive outcome; greater frequency of behaviors.
Baseline (pretest) and 6 weeks (posttest)
Parent Academic Enabling Behaviors
Time Frame: Baseline (pretest) and 6 weeks (posttest)
The Parent Academic Enabling Behaviors measure includes 13 items asking parents to estimate the frequency of their discrete academic enabling behaviors, such as helping their child learn the meaning of "scientific" words and using "scientific" words in a conversation with their child. The measure uses a 4-point scale of frequency with 1 being "Not at all" and 4 being " 3-4 times a week." A sum score including all 13 items was computed and can range between 13 and 52. Higher scores indicate a more positive outcome; greater frequency of behaviors.
Baseline (pretest) and 6 weeks (posttest)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Research Behavioral Intervention Strategies, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MD013619-01
  • R44MD013619 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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