Status:
COMPLETED
Using the LENA System in Early Intervention - b
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
North Carolina Translational and Clinical Sciences Institute
Conditions:
Depression
Eligibility:
FEMALE
18-99 years
Phase:
NA
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-f...
Detailed Description
Early Intervention (EI) services are provided to infants and toddlers with documented developmental delays in all 50 states and US territories. EI improves long-term infant-toddler adaptation and lowe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Currently pregnant by self-report.
- Child is completely deaf
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03480841
Start Date
April 2 2018
End Date
November 4 2018
Last Update
December 19 2019
Active Locations (1)
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1
Durham Children's Developmental Services Agency
Durham, North Carolina, United States, 27701