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Completed

NCT Number: NCT03547492

Developmental Intervention for Infants of Adolescent Mothers

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.

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Key information

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teaching Talking

Behavioral

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.

LENA recordings-language

Behavioral

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.

LENA recordings-motor

Behavioral

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.

Mastering Movement

Behavioral

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...

Language text messages

Behavioral

12 weekly text messages. Each is 1-2 sentences to review concepts of Teaching Talking

Motor text messages

Behavioral

4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement

Primary outcomes

  1. MacArthur CDI

    Time frame: 12 months

    MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores

Secondary outcomes

  1. LENA Counts

    Time frame: birth, 4 months, 12 months

    Adult word counts, conversational turns and infant vocalization of each LENA recording

  2. Ages & Stages Questionnaire

    Time frame: 4 months, 12 months

    Parent report of development at 4 and 12 months of age

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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