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Duet 2.0 Starting the Conversation: A New Intervention Model to Stimulate Language Growth in Underserved Populations

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ClinicalTrials.gov Identifier: NCT04692519
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
William Penn Foundation
Information provided by (Responsible Party):
Temple University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Language Development Language, Child Early Intervention Behavioral: Duet Language Intervention Modules Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: The principal investigator and postdoctoral fellow on the project will both be blind. Only the coordinator will know who is the in intervention group and who is in the delayed access group.
Primary Purpose: Prevention
Official Title: Duet 2.0: Starting the Conversation: A New Intervention Model to Stimulate Language Growth in Underserved Populations
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Arm Intervention/treatment
Experimental: Intervention
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.
Behavioral: Duet Language Intervention Modules
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.

No Intervention: Delayed Access
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Change in Self-Efficacy for Parenting Tasks-Toddler Scale [ Time Frame: Baseline, 3-month follow-up, and 6-month follow-up ]
    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.

  2. Change in Langauge Diversity [ 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 diverse words produced by caregivers.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • To be included in this study, Caregivers (Control and Intervention Groups)

Caregivers must:

  1. Live in a zip code that is within a 30-mile radius of Weiss Hall at Temple University
  2. Be 18;0 years of age or older
  3. Be a parent or legal guardian of participating child
  4. Speak English and/or Spanish (at least 80% of the time)
  5. Read English and/or Spanish "well" or "very well"
  6. Have weekly access to phone or internet
  7. Have adequate visual abilities to participate in the study (per participant report)
  8. 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).
  9. 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:

a. 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692519


Contacts
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Contact: Rebecca M Alper, Ph.D. 215-204-8537 ext 18537 tug34246@temple.edu
Contact: Brooke M Rumper, Ph.D. 267-468-8662 tun02399@temple.edu

Locations
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United States, Pennsylvania
The Children's Center Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Alexis Roman    215-634-2251    aroman@nscaphila.org   
Pediatrics Department at Temple University Health System Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Cindy Berry, BSB/A,MSPM,PMP    (215) 707-6106    Cindy.Berry@tuhs.temple.edu   
Contact: Stephen Aronoff, MD, MBA    (215) 707-6106    stephen.aronoff@tuhs.temple.edu   
Sponsors and Collaborators
Temple University
William Penn Foundation
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.
Barnard, K. E. (1998). Developing, implementing and documenting interventions with parents and young children. Zero to Three, 18(4), 23-29.
Birdson, D., Gertken, L.M., & Amengual, M. (2012). Bilingual Language Profile: An Easy-to-Use Instrument to Assess Bilingualism. COERLLL: University of Texas at Austin.
Coleman, 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.
Fenson, 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.
Hammer, C.S., Scarpino, S., Cycyk, L., Sawyer, B. & Jury (2015). Center for Early Care and Education Research - Dual Language Learners (CECER-DLL) Parent Questionnaire.
Hart, B., & Risley, T. R. (2003). The Early Catastrophe. The 30 Million Word Gap. American Educator, 27(1), 4-9.
Hoff, E. (2006). How social contexts support and shape language development. Developmental Review, 26(1), 55-88. https://doi.org/10.1016/j.dr.2005.11.002
Knauer, H. A., Ozer, E. J., Dow, W. H., & Fernald, L. C. H. (2018). Parenting quality at two developmental periods in early childhood and their association with child development. Early Childhood Research Quarterly. https://doi.org/10.1016/j.ecresq.2018.08.009
Luo, R., & Tamis-LeMonda, C. S. (2017). Reciprocity between maternal questions and child contributions during book-sharing. Early Childhood Research Quarterly, 38, 71-83. https://doi.org/10.1016/j.ecresq.2016.08.003
MacWhinney, B. (2000). The CHILDES Project: Tools for analyzing talk. (3rd Edition). Mahwah, NJ: Lawrence Erlbaum Associates.
Miller, J. & Iglesias, A. (2017). Systematic Analysis of Language Transcripts (SALT), Research Version 18 [Computer Software]. Madison, WI: SALT Software, LLC.
Murphey, D., Epstein, D., Shaw, S., McDaniel, T., & Steber, K. (2018). The status of infants and toddlers in Philadelphia. Child Trends. Retrieved from https://www.childtrends.org/wp-content/uploads/2018/08/PhiladelphiaInfantandToddlers_ChildTrends_September2018.pdf
Pace, A., Alper, R., Burchinal, M. R., Golinkoff, R. M., & Hirsh-Pasek, K. (2018). Measuring success: Within and cross-domain predictors of academic and social trajectories in elementary school. Early Childhood Research Quarterly. https://doi.org/10.1016/j.ecresq.2018.04.001
Peña, Guitierrez-Clellan, Igelsias, Goldstein, & Bedore (2018). Bilingual English-Spanish Assessment (BESA). Brookes Publishing.
Pew Charitable Trusts. (2017). Philadelphia's poor: Who they are, where they live, and how that's changed. Retrieved from https://www.pewtrusts.org/- /media/assets/2017/11/pri_philadelphias_poor.pdf
Powell, D. R., Diamond, K. E., Burchinal, M. R., & Koehler, M. J. (2010). Effects of an early literacy professional development intervention on head start teachers and children. Journal of Educational Psychology, 102(2), 299-312. https://doi.org/10.1037/a0017763
Radloff, L. (1977). The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement, 1(3), 385-401.
Squires, J., Bricker, D., Twombly, E., Nickel, R., Clifford, J., Murphy, K., … Farrell, J. (2009). Ages and Stages Questionnaire-Third Edition. Brookes Publishing Co.
Tamis-LeMonda, C. S., Kuchirko, Y., & Song, L. (2014). Why is infant language learning facilitated by parental responsiveness? Current Directions in Psychological Science, 23(2), 121-126. https://doi.org/10.1177/0963721414522813
Zimmerman, I. L., Steiner, V. G., & Pond, R. E. (2012). Preschool Language Scales, Fifth Edition Screening Test English and Spanish (PLS-5). Pearson Clinical.

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT04692519    
Other Study ID Numbers: 26412
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Temple University:
Language development
Low-income
Linguistically diverse
Culturally diverse