Clinical trial NCT03547492: Developmental Intervention for Infants of Adolescent Mothers
Official title: Developmental Intervention for Infants of Adolescent Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development, Child
Adolescent Behavior
Language Development
Language Delay
Keywords: language
LENA
adolescent
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Random assignment to language (intervention) or motor (control) focused curriculums
Primary purpose: PREVENTION

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:

1. Review language curriculum and motor curriculum with study personnel
2. Direct linguistic feedback of baseline LENA recording
3. 2nd LENA recording completed and analyzed
4. Direct or mailed linguistic feedback of 2nd LENA recording
5. 16- Weekly text messages
6. 4 month LENA recording with mailed linguistic feedback
7. 12 month LENA recording with mailed linguistic feedback

Control:

1. Review motor curriculum with study personnel
2. 2nd LENA recording completed and analyzed
3. 4- monthly text messages
4. 4 month LENA recording
5. 12 month LENA recording with mailed linguistic feedback of all recordings

Both groups undergo the following assessments:

1. Ages and Stages Questionnaire at 4 and 12 months
2. Maternal Peabody Picture Vocabulary test at 4 months
3. Edinburgh Post-partum Depression Scale at 4 months
4. MacArthur Bates Communicative Developmental Inventory: Words and Gestures at 12

Eligibility criteria: 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.

Primary outcomes:
measure: MacArthur CDI
timeFrame: 12 months
Secondary outcomes:
measure: LENA Counts
timeFrame: birth, 4 months, 12 months
measure: Ages & Stages Questionnaire
timeFrame: 4 months, 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Caskey M, Stephens B, Tucker R, Vohr B. Importance of parent talk on the development of preterm infant vocalizations. Pediatrics. 2011 Nov;128(5):910-6. doi: 10.1542/peds.2011-0609. Epub 2011 Oct 17.
citation: Squires J, Bricker D, Potter L. Revision of a parent-completed development screening tool: Ages and Stages Questionnaires. J Pediatr Psychol. 1997 Jun;22(3):313-28. doi: 10.1093/jpepsy/22.3.313.
citation: Thal D, Desjardin JL, Eisenberg LS. Validity of the MacArthur-Bates Communicative Development Inventories for measuring language abilities in children with cochlear implants. Am J Speech Lang Pathol. 2007 Feb;16(1):54-64. doi: 10.1044/1058-0360(2007/007).