Using the LENA System in Early Intervention

Withdrawn before enrolling · Not applicable

Conditions studied: Depression

In brief

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 randomized control trial using the Language ENhancement Assessment/intervention system (LENA), a technology-supported language monitoring system, with 20 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. A "LENA with feedback" group will follow participants in the intervention over 5 weeks: 5 weeks of LENA data collection (with mothers running the system 1 day/week for 16 consecutive hours), with feedback during 3 weeks (baseline=LENA, no feedback; 3 week intervention=LENA with feedback; post-intervention=LENA, no feedback). A "LENA no feedback" group will complete LENA data collection at baseline on the same schedule but will not receive feedback. The main difference between groups will be provision of LENA feedback and strategies to promote increased mother-child interactions. This design allows the investigators to isolate the effect of LENA with feedback, and minimizes attributing changes in language environments due to exposure to LENA alone. 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.

Key facts

Study ID: NCT03164642
Run by: University of North Carolina, Chapel Hill
People needed: 0
Starts: 2018-02-01
Expected to finish: 2018-03-01
Last updated by the study team: 2018-02-28

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Service Coordinator and Service Provider Inclusion:
Be a CDSA employee in Durham, Wake, Alamance or Guilford Counties, NC
Be a service coordinators or approved Speech-Language Provider(SLP) or Community Based Rehabilitative Service (CBRS) provider (service providers).
Eligibility of the service providers will be determined by the agreement of a mother to participate in the LENA portion of the study and the agreement of the service providers to participate as well.
Mothers Inclusion criteria:
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 PHQ-9. This score is indicative of depressive symptoms.

You may not qualify if…

Service Coordinator and Service Provider Inclusion: none
Mothers Exclusion criteria:
Currently pregnant by self-report.
Child is completely deaf

Where it is running

Durham Children's Developmental Services Agency — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.