Using the LENA System in Early Intervention - b

NCT03480841 | Completed Results

• 1 other identifier: 15-2105b
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This project will determine whether an intervention to enhance communication between infants and toddlers with developmental disabilities and their depressed mothers can be integrated into federally-funded Early Intervention (EI) services. Participants will be mothers with depressive symptoms whose children are receiving EI services, along with their EI service providers. The investigators will conduct a small feasibility trial using the Language ENhancement Assessment/intervention system (LENA), a technology-supported language monitoring system, with 10 mothers and one of their child's EI service providers. The LENA uses an infant or toddler garment with an integrated audiotape system that records adult speech centered on the child, child vocalizations, and reciprocal parent-child turn-taking conversations. The LENA software produces visual feedback that a mother can use to focus her language interactions with her child. They study will follow participants in the LENA with feedback intervention over 6 weeks: 5 weeks of LENA data collection (with mothers running the system 1 day/week for 16 consecutive hours). The investigators will analyze data from measures on LENA communication data (adult word count, child vocalizations and conversational turn-taking), and measures of child language, maternal depressive symptoms, and child disability profiles.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• LENA Adult Word Count Score at 6 Weeks

  The Language Enhancement/Intervention System (LENA), which records adult-child vocalizations, measures the number of the target adult's (e.g., parent) child-directed words (child-directed speech). The total possible range is 0-n, where higher scores indicate an increased number of child-directed words spoken by the target adult and higher degrees of a language-rich environment. Lower scores indicate fewer words spoken by the target adult and represent an environment that is not language-rich.

  at 6 weeks

Secondary Outcomes (5)

• Parenting Sense of Competence Scale Efficacy Subscale Score at 6 Weeks

  at 6 weeks

• Patient Health Questionnaire-9 (PHQ-9) Score at 6 Weeks

  at 6 weeks

• LENA Mother/Child Turn-Taking Score at 6 Weeks

  at 6 weeks

• LENA Child Vocalization Score at 6 Weeks

  at 6 weeks

• Generalized Anxiety Disorder (7-Item) Score at 6 Weeks

  at 6 weeks

Study Arms (1)

LENA with Feedback

EXPERIMENTAL

Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the language the home language environment.

Behavioral: Language ENhancement Assessment/intervention system

Interventions

Language ENhancement Assessment/intervention system BEHAVIORAL

The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.

LENA with Feedback

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years or older. Mothers who are 18 years can give consent independently.
• Be the biological or adoptive mother of an infant (6 weeks - 18 months old) or toddler (19 -32 months old) enrolled in EI at the time of recruitment; mothers must be the primary caretaker of the child.
• EI services are offered only to infants and toddlers up to the age of 36 months; this study caps the age of enrollment at 32 months to ensure that toddlers are continuously enrolled in EI during the data collection period.
• Able to independently give consent. Mothers must have adequate capacity to participate in the LENA intervention as well as understand what they will be asked to do as participants.
• Score 8 or higher on the Patient Health Questionnaire - (PHQ-9). This score is indicative of depressive symptoms.

You may not qualify if:

• Currently pregnant by self-report.
• Child is completely deaf

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

Durham Children's Developmental Services Agency

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Linda Beeber
• Organization: University of North Carolina at Chapel Hill

beeber@email.unc.edu

(919) 966-8148

Study Officials

• Linda Beeber, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Anne Wheeler, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Doré LaForett, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: April 2, 2018
• Primary Completion: November 4, 2018
• Study Completion: November 4, 2018
• Last Updated: December 19, 2019
• Results First Posted: December 6, 2019

Record last verified: 2019-02

Locations

US (1)