Using the LENA System in Early Intervention - b
Completed · 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 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.
Key facts
- Study ID
- NCT03480841
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 10
- Starts
- 2018-04-02
- Expected to finish
- 2018-11-04
- Last updated by the study team
- 2019-12-19
Who can join
Age: 18 and older, up to 99. Sex: female. Healthy volunteers: accepted.
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
Where it is running
- Durham Children's Developmental Services Agency — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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