Language DevelopmentNCT03766906
STEM (Science, Technology, Engineering & Math) Familia Talk
A study testing Talk STEM Familia app in people with Language Development, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Language Development
- What is being tested?
- Talk STEM Familia app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Behavioral Intervention Strategies, Inc.
Eugene, Oregon, 97403
About this study
Official title: 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.
Read the 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.
- Conditions
- Language Development
- Being tested
- Talk STEM Familia app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talk STEM Familia appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Talk STEM Familia App | Experimental | 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. Receives: Behavioral: Talk STEM Familia app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Academic Vocabulary Knowledge in English
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.
Measured: Baseline (pretest) and 6 weeks (posttest)
Parent Academic Vocabulary Knowledge in Spanish
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.
Measured: Baseline (pretest) and 6 weeks (posttest)
Student Academic Vocabulary Usage in English
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.
Measured: Baseline (pretest) and 6 weeks (posttest)
Parent Academic Vocabulary Usage in Spanish
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.
Measured: Baseline (pretest) and 6 weeks (posttest)
Secondary outcomes (4)
Student Engagement Instrument
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.
Measured: Baseline (pretest) and 6 weeks (posttest)
The Efficacy to Influence School-related Performance Subscale of the Parental Self-Efficacy Scale
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.
Measured: Baseline (pretest) and 6 weeks (posttest)
Student Academic Language Learning Behaviors
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.
Measured: Baseline (pretest) and 6 weeks (posttest)
Parent Academic Enabling Behaviors
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.
Measured: Baseline (pretest) and 6 weeks (posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Mar 2019
- Primary completion30 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One-arm, single-group, feasibility study with parent/student dyads.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- David R. Smith, PhD, Study chair, Oregon Research Behavioral Intervention Strategies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766906
- Sponsor's protocol ID
- MD013619-01
- Other IDs
- R44MD013619
- Status last verified
- Feb 2023
- First submitted
- 4 Dec 2018
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03766906
- Acronym / sponsor ID
- MD013619-01
- Conditions
- Language Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Posted 23 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One-arm, single-group, feasibility study with parent/student dyads.
| Arm | Type | Receives |
|---|---|---|
| Talk STEM Familia App | Experimental | Behavioral: Talk STEM Familia appThis 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Talk STEM Familia appThe 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. | Behavioural | Talk STEM Familia App |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Student Engagement Instrument
Time frame: 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)
Student Academic Language Learning Behaviors
Time frame: Baseline (pretest) and 6 weeks (posttest)
Parent Academic Enabling Behaviors
Time frame: Baseline (pretest) and 6 weeks (posttest)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David R. Smith, PhD study chair
Oregon Research Behavioral Intervention Strategies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talk STEM Familia app in people with Language Development, run by Oregon Research Behavioral Intervention Strategies, Inc. 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 4 inclusion and 4 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 8 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Student Academic Vocabulary Knowledge in English (time frame: Baseline (pretest) and 6 weeks (posttest)). 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?
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 8 Feb 2023.