Clinical Trials Directory

Trials / Completed

CompletedNCT03547492

Developmental Intervention for Infants of Adolescent Mothers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
108 (actual)
Sponsor
Women and Infants Hospital of Rhode Island · Academic / Other
Sex
All
Age
Healthy volunteers

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALTeaching TalkingWritten packet including 8 lessons: What's My Corrected Age, Watch Me Learn (language milestones in the 1st year of life), Reading Aloud, Sing-a-long: Sleepy Songs, Sing-a-long: Alert Songs, Copying First Sounds, Playing Games, Talk to Your Baby.
BEHAVIORALLENA recordings-languageLENA a special recording device. It records for 16 hours inside a specially designed infant vest. The recording is analyzed by a computer that generates an output of total number of adult words, infant vocalizations and conversational turns during the recording period. 4 LENA recordings are obtained: baseline, after reviewing Teaching Talking and linguistic feedback of first recording, 4 and 12 months of age. Participants are mailed feedback of their 2nd, 4 and 12 month recordings.
BEHAVIORALLENA recordings-motorLENA a special recording device. It records for 16 hours inside a specially designed infant vest. The recording is analyzed by a computer that generates an output of total number of adult words, infant vocalizations and conversational turns during the recording period. 4 LENA recordings are obtained: baseline, 2nd, 4 and 12 months of age. Participants are mailed feedback on recordings after completing study.
BEHAVIORALMastering MovementA written curriculum containing 5 lessons adopted from Beautiful Beginnings: What's My Corrected Age, Watch Me Move! (review of motor milestones in 1st year), Gentle Stretching and Exercise, Tummy Time, Help Me Learn to...
BEHAVIORALLanguage text messages12 weekly text messages. Each is 1-2 sentences to review concepts of Teaching Talking
BEHAVIORALMotor text messages4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement

Timeline

Start date
2013-01-25
Primary completion
2015-11-01
Completion
2018-02-01
First posted
2018-06-06
Last updated
2018-06-06

Source: ClinicalTrials.gov record NCT03547492. Inclusion in this directory is not an endorsement.