Developmental Intervention for Infants of Adolescent Mothers
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Women and Infants Hospital of Rhode Island
- Enrollment
- 108
- Primary Endpoint
- MacArthur CDI
Overview
Brief Summary
This is a randomized control trial to evaluate a simple language intervention curriculum that utilizes LENA recordings, linguistic feedback and text-message review of content to improve language environments and outcomes for infants with adolescent mothers.
Detailed Description
Mother-infant pairs are enrolled while in the hospital after birth. Enrolled participants are randomized into a language (intervention) or motor (control) group. All participants have a baseline LENA (device that captures 16 hour recording and associated computer analysis generates a report of numbers of adult words spoken, infant vocalization and conversational turns). Interventions after the baseline recording by group are as follows:
Intervention:
- Review language curriculum and motor curriculum with study personnel
- Direct linguistic feedback of baseline LENA recording
- 2nd LENA recording completed and analyzed
- Direct or mailed linguistic feedback of 2nd LENA recording
- 16- Weekly text messages
- 4 month LENA recording with mailed linguistic feedback
- 12 month LENA recording with mailed linguistic feedback
Control:
- Review motor curriculum with study personnel
- 2nd LENA recording completed and analyzed
- 4- monthly text messages
- 4 month LENA recording
- 12 month LENA recording with mailed linguistic feedback of all recordings
Both groups undergo the following assessments:
- Ages and Stages Questionnaire at 4 and 12 months
- Maternal Peabody Picture Vocabulary test at 4 months
- Edinburgh Post-partum Depression Scale at 4 months
- MacArthur Bates Communicative Developmental Inventory: Words and Gestures at 12
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infants ≥30 weeks born to 15-20 year old mothers
Exclusion Criteria
- •Congenital anomalies associated with adverse developmental outcomes
- •Non-English speaking mothers
- •No cell phone
- •Mother not available for follow-up
- •State custody of mother or infant.
Outcomes
Primary Outcomes
MacArthur CDI
Time Frame: 12 months
MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores
Secondary Outcomes
- LENA Counts(birth, 4 months, 12 months)
- Ages & Stages Questionnaire(4 months, 12 months)