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

NCT04692519 | Unknown

• 1 other identifier: 26412
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Language Development; Language, Child; Early Intervention

Keywords

Language development; Low-income; Linguistically diverse; Culturally diverse

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 3-month follow-up, and 6-month follow-up

Secondary Outcomes (2)

• Change in Self-Efficacy for Parenting Tasks-Toddler Scale

  Baseline, 3-month follow-up, and 6-month follow-up

• Change in Langauge Diversity

  Baseline, 3-month follow-up, and 6-month follow-up

Study Arms (2)

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.

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.

Interventions

Duet Language Intervention Modules BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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:
• 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).

Sponsors & Collaborators

• Temple University: lead
• William Penn Foundation: collaborator

Study Sites (1)

Pediatrics Department at Temple University Health System

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Related Publications (46)

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MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

Communication; Behavior

Central Study Contacts

Rebecca M Alper, Ph.D.

CONTACT

215-204-8537; tug34246@temple.edu

Kathy Hirsh-Pasek, Ph.D.

CONTACT

khirshpa@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 31, 2020
• Study Start: December 18, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)