Clinical trial NCT04692519: Duet 2.0 Starting the Conversation: A New Intervention Model to Stimulate Language Growth in Underserved Populations
Official title: Duet 2.0: Starting the Conversation: A New Intervention Model to Stimulate Language Growth in Underserved Populations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Language Development
Language, Child
Early Intervention
Keywords: Language development
Low-income
Linguistically diverse
Culturally diverse
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: William Penn Foundation
First posted: 2020-12-31
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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).

Primary outcomes:
measure: Change in Quality of Caregiver-Child Language Interaction
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
measure: Change in Parent/Provider Expectations and Knowledge
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
measure: Change in MacArthur-Bates Communication Development Inventories (MBCDI)
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
Secondary outcomes:
measure: Change in Self-Efficacy for Parenting Tasks-Toddler Scale
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
measure: Change in Langauge Diversity
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pediatrics Department at Temple University Health System
state: Pennsylvania
Study officials:
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