Language DevelopmentNCT04692519
Duet 2.0 Starting the Conversation: A New Intervention Model to Stimulate Language Growth in Underserved Populations
A study testing Duet Language Intervention Modules in people with Language Development and Language, Child, run by Temple University at 1 site in United States.
Trial summary
Caregiver-child language interactions in the first three years of life predict early language development, school readiness, and academic achievement. Despite the importance of these factors, there are disparities in the frequency and quality of children's early language interactions. Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Language Development, Language, Child, Early Intervention
- What is being tested?
- Duet Language Intervention Modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 1 Jun 2023
- 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 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be included in this study, Caregivers (Control and Intervention Groups)
- Caregivers must:
- Live in a zip code that is within a 30-mile radius of Weiss Hall at Temple University
- Be 18;0 years of age or older
- Be a parent or legal guardian of participating child
- Speak English and/or Spanish (at least 80% of the time)
Show all 13Show fewer
- Read English and/or Spanish "well" or "very well"
- Have weekly access to phone or internet
- Have adequate visual abilities to participate in the study (per participant report)
- Have no hearing impairment or loss (per participant report) OR if some hearing impairment or loss, have received amplification (e.g., hearing aid, cochlear implants) and speak spoken (e.g., not signed) language as their primary mode of communication (per participant report).
- Qualify as Low-Socioeconomic Status (Low-SES), which is defined as, being at or below 200% of the Federal Poverty Guideline (FPG) and having no more than a 4-year college degree
- To be included in this study, children (Control and Intervention Groups) must:
- Be between 12 and 30 months at baseline b. Be Spanish and/or English learners (at least 80% of the time), as defined by c. Have already acquired verbal or non-verbal intentional language (e.g., gesture to get someone's attention and/or point to request and obtain a toy) and speak no more than three-word utterances (per caregiver report) d. Have adequate visual abilities to participate in the study (per caregiver report) e. Have no hearing impairment or loss (per caregiver report) OR if some hearing impairment or loss, have received amplification (e.g., hearing aid, cochlear implants) and be learning spoken (e.g., not signed) language as their primary mode of communication (per caregiver report).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Kathy Hirsh-Pasek, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Pediatrics Department at Temple University Health System
Philadelphia, Pennsylvania, 19140
Cindy Berry, BSB/A,MSPM,PMP, (215) 707-6106, Cindy.Berry@tuhs.temple.edu
Stephen Aronoff, MD, MBA, (215) 707-6106, stephen.aronoff@tuhs.temple.edu
About this study
Official title: Duet 2.0: Starting the Conversation: A New Intervention Model to Stimulate Language Growth in Underserved Populations
Caregiver-child language interactions in the first three years of life predict early language development, school readiness, and academic achievement. Despite the importance of these factors, there are disparities in the frequency and quality of children's early language interactions. Although there is within-group variability, children from low-income families, on average, have fewer and lower-quality language experiences than their middle- or high-income peers. The current study addresses a need in the community for an early language intervention accessible to low-income families who speak Spanish. This study will build upon research conducted in a previous study, "Enhancing the Communication Foundation-The Duet Project", by piloting the English and Spanish modules with families through a light-touch, remote intervention delivery model. Temple University Health System's Department of Pediatrics will aid in identifying participants. Baseline and follow-up measures will be used to evaluate caregiver knowledge of child development, psychosocial perceptions, demographics, caregiver-child language interaction quality, and child language skills. It is hypothesized that dyads who receive the intervention will make greater gains in early interaction quality, knowledge of child development, and child language skills than the delayed-access control group. This work has the potential to shape early intervention design and implementation for people in underserved communities across the country.
Read the detailed description
Objectives and Background
The purpose of this study is to determine whether Duet 2.0- a light-touch, public health model of remote intervention delivery 1) increases caregiver knowledge about children's language development, 2) improves caregiver-child language interaction quantity and quality, and 3) enhances children's language skills. It is hypothesized that dyads who receive the Duet 2.0 intervention will make greater gains in knowledge of child development, early interaction quality, and child language skills than the delayed-access control group. Secondary analyses will be conducted to examine if and how parent (e.g., self-efficacy) and child (e.g., child language abilities) characteristics relate to each other, baseline measures, and treatment outcomes.
Early language skills are fundamental to language, cognitive, and socioemotional development and are the single best predictors of later academic success. Caregiver-child language interactions in the first three years of life not only predict early language development, but also influence school readiness skills and academic achievement. High-quality early language interactions are characterized by rich and diverse vocabulary, responsive talk (i.e., language following the child's attention), decontextualized language (e.g., language beyond the here and now context, "Remember we went to a party last night"), communication foundation (e.g., use of verbal and gestural symbols, engaging in back-and-forth conversations), and question use. In fact, early reading outcomes are particularly contingent on strong language skills that go beyond and accompany strong decoding skills.
Despite the importance of these factors, there are large disparities in the frequency and quality of children's early language interactions. Although there is great within-group variability, children from low-income families on average have fewer and lower-quality language experiences than their middle- or high-income peers. Early disparities in language experiences can lead to gaps in language skills and academic achievement that persist into adulthood.
Duet 2.0 will adopt an innovative and scalable approach-remote delivery and coaching. This design reflects arguably the strongest evidence for successful intervention. Remote coaching and telehealth are becoming accepted models for public health intervention in domains like nutrition, fitness, heart health, and diabetes. There is also growing support for remote delivery parent and teacher training programs. For instance, remote coaching has effectively improved Head Start teachers' language and literacy practices. This intervention model has also been used successfully to promote mental health in parents of infants, train parents in domains such as child socioemotional development, and support language and communication in young children with autism.
With the support of the William Penn Foundation and the Bezos Family Foundation, the PIs spent three years designing and piloting a caregiver- implemented early language intervention program-The Duet Project: Early Engagement, Future Success. Using community-based participatory research (CBPR) framework with partners at the Maternity Care Coalition (MCC), the PIs created Duet training materials that are evidence-based and culturally sensitive.
Pilot work with Duet yielded promising findings despite low sample sizes. These preliminary results support the efficacy of the Duet modules. Duet participants included some Spanish speakers; however, all participants had to be able to receive services in English. This significantly limited recruitment-nearly 25% of infants and toddlers in Philadelphia are of Latino/Hispanic origin. Furthermore, the percent of Hispanic/Latino people living in poverty is disproportionately high-they make up 21% of the population living in poverty but only 14.4% of the total population.
Translating the Duet modules into Spanish and developing a more efficient delivery system will maximize their scalability and positive impact on low-SES families. Establishing an efficient communication foundation, will enhance language learning and literacy development with the goal of narrowing the achievement gap in future generations. Given the undeniably powerful link between early language competencies and later literacy skills, this intervention has the potential to have long-lasting and widespread benefits both at local and national levels.
Duet 2.0 Intervention and Data Collection
Prospective research participants will be identified and recruited through the Department of Pediatrics at Temple University Health System(TUHS) and possibly by sharing recruitment materials with local community organizations (e.g., Early Head Start centers). Participants will be recruited and screened. If they meet study requirements during screening, they will then be consented and enrolled. Families who are randomly selected into the intervention group will complete the modules at home on their own time and receive remote coaching from an interventionist or coach (terms used interchangeably). Families in the delayed-access control group will receive access to the modules at the end of the study, but will still complete data-collection sessions. Approximately once a week after enrollment, Interventionists will support the intervention-group families remotely in comprehending and implementing what they have learned from the modules. Interventionists may also be involved in remote data collection. All participants will be scheduled for follow-up data collection sessions via phone or video conference.
- Conditions
- Language Development, Language, Child, Early Intervention
- Being tested
- Duet Language Intervention Modules
- Keywords
- Language development, Low-income, Linguistically diverse, Culturally diverse
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duet Language Intervention ModulesBehavioural
The Duet 2.0 intervention modules promote the following guiding principles that help build effective communication. Below are the 5 principles covered in the six Duet modules: 1) General Awareness: Awareness and knowledge of child development 2) Creating Opportunities: Opportunities for communication during everyday activities 3) Conversational Duets: Rhythmic and reciprocal early language interactions 4) Scaffolding: Providing just enough help to support child independence 5) Harmonizing: Using the strategies together. These modules, which include behavioral strategies, real-life and animated examples of high-quality early language interactions, and interactive scenarios. The modules were informed and narrated by community members and carefully designed to address specific needs of high-risk communities. The modules have also been translated into Spanish, making sure to encompass specific cultural and dialect needs. Translation accuracy was verified by a qualified Spanish translator.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Duet 2.0 intervention is comprised of six training modules, which include behavioral strategies, real-life and animated examples of high-quality early language interactions, and interactive scenarios. Modules were translated into Spanish. Participants will watch one Duet intervention module a week and have up to 3 months to complete all 6 modules. As intervention families review the modules on their own time at home, they will receive remote coaching from an assigned interventionist and weekly module-specific fidelity/comprehension questions. Interventionists will check-in weekly via phone or video (~30-60 minutes), whichever is more convenient for the family. During the check-in, interventionists will do teach-back about the module, guide the family on how to incorporate the strategies into their daily lives, and provide feedback. Intervention participants will be scheduled for follow-up data collection at 3 months, 6 months, and pending funding, 1-year after baseline. Receives: Behavioral: Duet Language Intervention Modules |
| Delayed Access | No intervention | Participants who are in the delayed access control group will not have to complete the modules and will be scheduled for a 3-month, 6-month, and pending funding, a 1-year follow-up calls. They will have delayed access to the modules, which means that they will receive access to the module videos at their 6-month study session and will be offered the opportunity to contact the research team with any questions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Caregiver-Child Language Interaction
To assess the quality of caregiver-child interactions, caregivers and participating children will be filmed or film themselves for a total of 10-15 minutes, at baseline, 3-month, and 6-month follow-up sessions. We will calculate the number of conversational turns.
Measured: Baseline, 3-month follow-up, and 6-month follow-up
Change in Parent/Provider Expectations and Knowledge
Caregiver's knowledge of child development will be assessed at baseline and post intervention. The Parent/Provider Expectations and Knowledge-II (SPEAK-II) is a well-validated measure used in similar research. Higher scores on the SPEAK-II indicate more knowledge about early language development.
Measured: Baseline, 3-month follow-up, and 6-month follow-up
Change in MacArthur-Bates Communication Development Inventories (MBCDI)
The MacArthur-Bates Communication Development Inventories (MBCDI) will be given to caregivers at baseline and follow-up sessions to measure children's vocabulary. The more vocabulary words on the MBCDI that a parent reports that their child knows, the larger the child's vocabulary.
Measured: Baseline, 3-month follow-up, and 6-month follow-up
Secondary outcomes (2)
Change in Self-Efficacy for Parenting Tasks-Toddler Scale
The Self-Efficacy for Parenting Tasks-Toddler Scale will be used to assess caregivers' self-efficacy in the areas of play and teaching. The scale uses a Likert-scale to indicate how well caregivers see themselves doing a certain parenting skill. Higher scores on the Self-Efficacy Scale indicate higher levels of self-efficacy.
Measured: Baseline, 3-month follow-up, and 6-month follow-up
Change in Langauge Diversity
To assess the quality of caregiver-child interactions, caregivers and participating children will be filmed or film themselves for a total of 10-15 minutes, at baseline, 3-month, and 6-month follow-up sessions. We will calculate the number of diverse words produced by caregivers.
Measured: Baseline, 3-month follow-up, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020 (estimated)
- Study start18 Dec 2020
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who are selected to participate in the intervention will be given access to videos containing the Duet intervention modules. We will ask families to watch one Duet module a week, if possible. They will have up to 3 months to complete the 6 modules. Intervention participants will be scheduled for follow-up data collection at 3 months, 6 months, and pending funding, 1-year after baseline. Participants who are in the delayed access control group will not have to complete the modules and will be scheduled for a 3-month, 6-month, and pending funding, a 1-year follow-up calls. They will have delayed access to the modules, which means that they will receive access to the module videos at their 6-month study session and will be offered the opportunity to contact the research team with any questions.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- William Penn Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692519
- Sponsor's protocol ID
- 26412
- Status last verified
- May 2022
- First submitted
- 16 Dec 2020
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alper, R.M., Luo, R., Hirsh-Pasek, K., Mogul, M., Chen, Y., Masek, L., Paterson, S., Pace, A., Adamson, L., Bakeman, R., Golinkoff, R., Owen, M. (under review). Improving child language outcomes for children in low-income households: The Duet Project.
Baggett KM, Davis B, Feil EG, Sheeber LB, Landry SH, Carta JJ, Leve C. Technologies for expanding the reach of evidence-based interventions: Preliminary results for promoting social-emotional development in early childhood. Topics Early Child Spec Educ. 2010 Feb 1;29(4):226-238. doi: 10.1177/0271121409354782. No abstract available.
PubMed 20454545Barnard, K. E. (1998). Developing, implementing and documenting interventions with parents and young children. Zero to Three, 18(4), 23-29.
Bedore LM, Pena ED, Summers CL, Boerger KM, Resendiz MD, Greene K, Bohman TM, Gillam RB. The measure matters: Language dominance profiles across measures in Spanish-English bilingual children. Biling (Camb Engl). 2012 Jul;15(3):616-629. doi: 10.1017/S1366728912000090. Epub 2012 Mar 20.
PubMed 23565049Birdson, D., Gertken, L.M., & Amengual, M. (2012). Bilingual Language Profile: An Easy-to-Use Instrument to Assess Bilingualism. COERLLL: University of Texas at Austin.
Black JT, Romano PS, Sadeghi B, Auerbach AD, Ganiats TG, Greenfield S, Kaplan SH, Ong MK; BEAT-HF Research Group. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial. Trials. 2014 Apr 13;15:124. doi: 10.1186/1745-6215-15-124.
PubMed 24725308Cartmill EA, Armstrong BF 3rd, Gleitman LR, Goldin-Meadow S, Medina TN, Trueswell JC. Quality of early parent input predicts child vocabulary 3 years later. Proc Natl Acad Sci U S A. 2013 Jul 9;110(28):11278-83. doi: 10.1073/pnas.1309518110. Epub 2013 Jun 24.
PubMed 23798423Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Coleman, P. K., & Karraker, K. H. (2003). Maternal self-efficacy beliefs, competence in parenting, and toddlers' behavior and developmental status. Infant Mental Health Journal, 24(2), 126-148. https://doi.org/10.1002/imhj.10048
Dickinson, D. K., Golinkoff, R. M., & Hirsh-Pasek, K. (2010). Speaking out for language: Why language Is central to reading development. Educational Researcher, 39(4), 305-310. https://doi.org/10.3102/0013189X10370204
Eaton WW, Muntaner C, Smith C, Tien A, Ybarra M. Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R). In: Maruish ME, ed. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment. 3rd ed. Mahwah, NJ: Lawrence Erlbaum; 2004:363-377.
Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
PubMed 9635069Fenson, L., Pethick, S., Renda, C., Cox, J. L., Dale, P. S., & Reznick, J. S. (2000). Short-form versions of the MacArthur Communicative Development Inventories. Applied Psycholinguistics, 21(1), 95-116.
Fernald A, Marchman VA, Weisleder A. SES differences in language processing skill and vocabulary are evident at 18 months. Dev Sci. 2013 Mar;16(2):234-248. doi: 10.1111/desc.12019. Epub 2012 Dec 8.
PubMed 23432833Goldin-Meadow S, Levine SC, Hedges LV, Huttenlocher J, Raudenbush SW, Small SL. New evidence about language and cognitive development based on a longitudinal study: hypotheses for intervention. Am Psychol. 2014 Sep;69(6):588-99. doi: 10.1037/a0036886. Epub 2014 Jun 9.
PubMed 24911049
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duet 2.0: Starting the Conversation: A New Intervention Model to Stimulate Language Growth in Underserved Populations
- ClinicalTrials.gov ID
- NCT04692519
- Acronym / sponsor ID
- 26412
- Conditions
- Language Development, Language, Child, Early Intervention
- Keywords
- Language development, Low-income, Linguistically diverse, Culturally diverse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- William Penn Foundation
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 31 Dec 2020 (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.
Caregiver-child language interactions in the first three years of life predict early language development, school readiness, and academic achievement. Despite the importance of these factors, there are disparities in the frequency and quality of children's early language interactions. Although there is within-group variability, children from low-income families, on average, have fewer and lower-quality language experiences than their middle- or high-income peers. The current study addresses a need in the community for an early language intervention accessible to low-income families who speak Spanish. This study will build upon research conducted in a previous study, "Enhancing the Communication Foundation-The Duet Project", by piloting the English and Spanish modules with families through a light-touch, remote intervention delivery model. Temple University Health System's Department of Pediatrics will aid in identifying participants. Baseline and follow-up measures will be used to evaluate caregiver knowledge of child development, psychosocial perceptions, demographics, caregiver-child language interaction quality, and child language skills. It is hypothesized that dyads who receive the intervention will make greater gains in early interaction quality, knowledge of child development, and child language skills than the delayed-access control group. This work has the potential to shape early intervention design and implementation for people in underserved communities across the country.
Detailed description
Objectives and Background
The purpose of this study is to determine whether Duet 2.0- a light-touch, public health model of remote intervention delivery 1) increases caregiver knowledge about children's language development, 2) improves caregiver-child language interaction quantity and quality, and 3) enhances children's language skills. It is hypothesized that dyads who receive the Duet 2.0 intervention will make greater gains in knowledge of child development, early interaction quality, and child language skills than the delayed-access control group. Secondary analyses will be conducted to examine if and how parent (e.g., self-efficacy) and child (e.g., child language abilities) characteristics relate to each other, baseline measures, and treatment outcomes.
Early language skills are fundamental to language, cognitive, and socioemotional development and are the single best predictors of later academic success. Caregiver-child language interactions in the first three years of life not only predict early language development, but also influence school readiness skills and academic achievement. High-quality early language interactions are characterized by rich and diverse vocabulary, responsive talk (i.e., language following the child's attention), decontextualized language (e.g., language beyond the here and now context, "Remember we went to a party last night"), communication foundation (e.g., use of verbal and gestural symbols, engaging in back-and-forth conversations), and question use. In fact, early reading outcomes are particularly contingent on strong language skills that go beyond and accompany strong decoding skills.
Despite the importance of these factors, there are large disparities in the frequency and quality of children's early language interactions. Although there is great within-group variability, children from low-income families on average have fewer and lower-quality language experiences than their middle- or high-income peers. Early disparities in language experiences can lead to gaps in language skills and academic achievement that persist into adulthood.
Duet 2.0 will adopt an innovative and scalable approach-remote delivery and coaching. This design reflects arguably the strongest evidence for successful intervention. Remote coaching and telehealth are becoming accepted models for public health intervention in domains like nutrition, fitness, heart health, and diabetes. There is also growing support for remote delivery parent and teacher training programs. For instance, remote coaching has effectively improved Head Start teachers' language and literacy practices. This intervention model has also been used successfully to promote mental health in parents of infants, train parents in domains such as child socioemotional development, and support language and communication in young children with autism.
With the support of the William Penn Foundation and the Bezos Family Foundation, the PIs spent three years designing and piloting a caregiver- implemented early language intervention program-The Duet Project: Early Engagement, Future Success. Using community-based participatory research (CBPR) framework with partners at the Maternity Care Coalition (MCC), the PIs created Duet training materials that are evidence-based and culturally sensitive.
Pilot work with Duet yielded promising findings despite low sample sizes. These preliminary results support the efficacy of the Duet modules. Duet participants included some Spanish speakers; however, all participants had to be able to receive services in English. This significantly limited recruitment-nearly 25% of infants and toddlers in Philadelphia are of Latino/Hispanic origin. Furthermore, the percent of Hispanic/Latino people living in poverty is disproportionately high-they make up 21% of the population living in poverty but only 14.4% of the total population.
Translating the Duet modules into Spanish and developing a more efficient delivery system will maximize their scalability and positive impact on low-SES families. Establishing an efficient communication foundation, will enhance language learning and literacy development with the goal of narrowing the achievement gap in future generations. Given the undeniably powerful link between early language competencies and later literacy skills, this intervention has the potential to have long-lasting and widespread benefits both at local and national levels.
Duet 2.0 Intervention and Data Collection
Prospective research participants will be identified and recruited through the Department of Pediatrics at Temple University Health System(TUHS) and possibly by sharing recruitment materials with local community organizations (e.g., Early Head Start centers). Participants will be recruited and screened. If they meet study requirements during screening, they will then be consented and enrolled. Families who are randomly selected into the intervention group will complete the modules at home on their own time and receive remote coaching from an interventionist or coach (terms used interchangeably). Families in the delayed-access control group will receive access to the modules at the end of the study, but will still complete data-collection sessions. Approximately once a week after enrollment, Interventionists will support the intervention-group families remotely in comprehending and implementing what they have learned from the modules. Interventionists may also be involved in remote data collection. All participants will be scheduled for follow-up data collection sessions via phone or video conference.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants who are selected to participate in the intervention will be given access to videos containing the Duet intervention modules. We will ask families to watch one Duet module a week, if possible. They will have up to 3 months to complete the 6 modules. Intervention participants will be scheduled for follow-up data collection at 3 months, 6 months, and pending funding, 1-year after baseline. Participants who are in the delayed access control group will not have to complete the modules and will be scheduled for a 3-month, 6-month, and pending funding, a 1-year follow-up calls. They will have delayed access to the modules, which means that they will receive access to the module videos at their 6-month study session and will be offered the opportunity to contact the research team with any questions.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Duet Language Intervention ModulesThe Duet 2.0 intervention is comprised of six training modules, which include behavioral strategies, real-life and animated examples of high-quality early language interactions, and interactive scenarios. Modules were translated into Spanish. Participants will watch one Duet intervention module a week and have up to 3 months to complete all 6 modules. As intervention families review the modules on their own time at home, they will receive remote coaching from an assigned interventionist and weekly module-specific fidelity/comprehension questions. Interventionists will check-in weekly via phone or video (~30-60 minutes), whichever is more convenient for the family. During the check-in, interventionists will do teach-back about the module, guide the family on how to incorporate the strategies into their daily lives, and provide feedback. Intervention participants will be scheduled for follow-up data collection at 3 months, 6 months, and pending funding, 1-year after baseline. |
| Delayed Access | No intervention | –Participants who are in the delayed access control group will not have to complete the modules and will be scheduled for a 3-month, 6-month, and pending funding, a 1-year follow-up calls. They will have delayed access to the modules, which means that they will receive access to the module videos at their 6-month study session and will be offered the opportunity to contact the research team with any questions. |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- To be included in this study, Caregivers (Control and Intervention Groups)
- Live in a zip code that is within a 30-mile radius of Weiss Hall at Temple University
- Be 18;0 years of age or older
- Be a parent or legal guardian of participating child
- Speak English and/or Spanish (at least 80% of the time)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Duet Language Intervention ModulesThe Duet 2.0 intervention modules promote the following guiding principles that help build effective communication. Below are the 5 principles covered in the six Duet modules: 1) General Awareness: Awareness and knowledge of child development 2) Creating Opportunities: Opportunities for communication during everyday activities 3) Conversational Duets: Rhythmic and reciprocal early language interactions 4) Scaffolding: Providing just enough help to support child independence 5) Harmonizing: Using the strategies together. These modules, which include behavioral strategies, real-life and animated examples of high-quality early language interactions, and interactive scenarios. The modules were informed and narrated by community members and carefully designed to address specific needs of high-risk communities. The modules have also been translated into Spanish, making sure to encompass specific cultural and dialect needs. Translation accuracy was verified by a qualified Spanish translator. | Behavioural | Intervention |
Primary outcome
Change in Quality of Caregiver-Child Language Interaction
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
To assess the quality of caregiver-child interactions, caregivers and participating children will be filmed or film themselves for a total of 10-15 minutes, at baseline, 3-month, and 6-month follow-up sessions. We will calculate the number of conversational turns.
Change in Parent/Provider Expectations and Knowledge
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
Caregiver's knowledge of child development will be assessed at baseline and post intervention. The Parent/Provider Expectations and Knowledge-II (SPEAK-II) is a well-validated measure used in similar research. Higher scores on the SPEAK-II indicate more knowledge about early language development.
Change in MacArthur-Bates Communication Development Inventories (MBCDI)
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
The MacArthur-Bates Communication Development Inventories (MBCDI) will be given to caregivers at baseline and follow-up sessions to measure children's vocabulary. The more vocabulary words on the MBCDI that a parent reports that their child knows, the larger the child's vocabulary.
2 secondary outcomes
Change in Self-Efficacy for Parenting Tasks-Toddler Scale
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
Change in Langauge Diversity
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- BackgroundAlper, R.M., Luo, R., Hirsh-Pasek, K., Mogul, M., Chen, Y., Masek, L., Paterson, S., Pace, A., Adamson, L., Bakeman, R., Golinkoff, R., Owen, M. (under review). Improving child language outcomes for children in low-income households: The Duet Project.
- Background: PubMed 20454545Baggett KM, Davis B, Feil EG, Sheeber LB, Landry SH, Carta JJ, Leve C. Technologies for expanding the reach of evidence-based interventions: Preliminary results for promoting social-emotional development in early childhood. Topics Early Child Spec Educ. 2010 Feb 1;29(4):226-238. doi: 10.1177/0271121409354782. No abstract available.
- BackgroundBarnard, K. E. (1998). Developing, implementing and documenting interventions with parents and young children. Zero to Three, 18(4), 23-29.
- Background: PubMed 23565049Bedore LM, Pena ED, Summers CL, Boerger KM, Resendiz MD, Greene K, Bohman TM, Gillam RB. The measure matters: Language dominance profiles across measures in Spanish-English bilingual children. Biling (Camb Engl). 2012 Jul;15(3):616-629. doi: 10.1017/S1366728912000090. Epub 2012 Mar 20.
- BackgroundBirdson, D., Gertken, L.M., & Amengual, M. (2012). Bilingual Language Profile: An Easy-to-Use Instrument to Assess Bilingualism. COERLLL: University of Texas at Austin.
- Background: PubMed 24725308Black JT, Romano PS, Sadeghi B, Auerbach AD, Ganiats TG, Greenfield S, Kaplan SH, Ong MK; BEAT-HF Research Group. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial. Trials. 2014 Apr 13;15:124. doi: 10.1186/1745-6215-15-124.
- Background: PubMed 23798423Cartmill EA, Armstrong BF 3rd, Gleitman LR, Goldin-Meadow S, Medina TN, Trueswell JC. Quality of early parent input predicts child vocabulary 3 years later. Proc Natl Acad Sci U S A. 2013 Jul 9;110(28):11278-83. doi: 10.1073/pnas.1309518110. Epub 2013 Jun 24.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundColeman, P. K., & Karraker, K. H. (2003). Maternal self-efficacy beliefs, competence in parenting, and toddlers' behavior and developmental status. Infant Mental Health Journal, 24(2), 126-148. https://doi.org/10.1002/imhj.10048
- BackgroundDickinson, D. K., Golinkoff, R. M., & Hirsh-Pasek, K. (2010). Speaking out for language: Why language Is central to reading development. Educational Researcher, 39(4), 305-310. https://doi.org/10.3102/0013189X10370204
- BackgroundEaton WW, Muntaner C, Smith C, Tien A, Ybarra M. Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R). In: Maruish ME, ed. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment. 3rd ed. Mahwah, NJ: Lawrence Erlbaum; 2004:363-377.
- Background: PubMed 9635069Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
- 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.
Kathy Hirsh-Pasek, Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duet Language Intervention Modules in people with Language Development and Language, Child, run by Temple University 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 13 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 12 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca M Alper, Ph.D. (215-204-8537 ext. 18537, tug34246@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Caregiver-Child Language Interaction (time frame: Baseline, 3-month follow-up, and 6-month follow-up). The study lists 3 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 NCT04692519, which also lists 46 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 12 May 2022; AzTrials last refreshed its copy on 30 Oct 2026.