Developmental Intervention for Infants of Adolescent Mothers

Study Overview
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Brief Summary
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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
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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

Official Title
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Developmental Intervention for Infants of Adolescent Mothers

Conditions
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Development, Child, Adolescent Behavior, Language Development, Language Delay

Intervention / Treatment
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* Behavioral: Teaching Talking
* Behavioral: LENA recordings-language
* Behavioral: LENA recordings-motor
* Behavioral: Mastering Movement
* Behavioral: Language text messages
* Behavioral: Motor text messages


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Random assignment to language (intervention) or motor (control) focused curriculums
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Language Intervention<br>1. Baseline LENA recording 2. Review language curriculum and motor curriculum with study personnel 2. Direct linguistic feedback of baseline LENA recording 4. 2nd LENA recording completed and analyzed 5. Direct or mailed linguistic feedback of 2nd LENA recording 6. 16- Weekly text messages 7. 4 month LENA recording with mailed linguistic feedback 8. 12 month LENA recording with mailed linguistic feedback 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 Participants receive a book at each interaction. | Behavioral: Teaching Talking<br>* Written 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.<br>Behavioral: LENA recordings-language<br>* LENA 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.<br>Behavioral: Mastering Movement<br>* A 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...<br>Behavioral: Language text messages<br>* 12 weekly text messages. Each is 1-2 sentences to review concepts of Teaching Talking<br>Behavioral: Motor text messages<br>* 4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement<br>|
| Active Comparator: Motor Control<br>Baseline LENA recording 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 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 Participants receive a toy at each interaction. | Behavioral: LENA recordings-motor<br>* LENA 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.<br>Behavioral: Mastering Movement<br>* A 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...<br>Behavioral: Motor text messages<br>* 4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MacArthur CDI | MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LENA Counts | Adult word counts, conversational turns and infant vocalization of each LENA recording | birth, 4 months, 12 months | 
| Ages & Stages Questionnaire | Parent report of development at 4 and 12 months of age | 4 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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language, LENA, adolescent