Recruiting

Language Growth

Sponsor:

Temple University

Code:

NCT04692519

Conditions

Language Development

Language, Child

Early Intervention

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Accepted

Interventions

Duet Language Intervention Modules

Study Details

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

Study ID

NCT04692519

Start date

Dec 18, 2020

Status verified date

May, 2022

Completion date

Jun 1, 2023

Anticipated

Primary completion date

Jun 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Change in Quality of Caregiver-Child Language Interaction [ Time Frame: Baseline, 3-month follow-up, and 6-month follow-up ]
  • Change in Parent/Provider Expectations and Knowledge [ Time Frame: Baseline, 3-month follow-up, and 6-month follow-up ]
  • Change in MacArthur-Bates Communication Development Inventories (MBCDI) [ Time Frame: Baseline, 3-month follow-up, and 6-month follow-up ]

Central Contacts and Locations

Central contacts

Rebecca M Alper, Ph.D.

215-204-8537tug34246@temple.edu

Kathy Hirsh-Pasek, Ph.D.

khirshpa@temple.edu

Locations

Pediatrics Department at Temple University Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Cindy Berry, BSB/A,MSPM,PMP

(215) 707-6106Cindy.Berry@tuhs.temple.edu

Stephen Aronoff, MD, MBA

(215) 707-6106stephen.aronoff@tuhs.temple.edu

More Information

Sponsor

Temple University

Last update posted

May 12, 2022

Last verified

May, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Temple University on 2022-05-12.