NCT03547492

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

2.8 years

First QC Date

May 24, 2018

Last Update Submit

May 24, 2018

Conditions

Development, ChildAdolescent BehaviorLanguage DevelopmentLanguage Delay

Keywords

languageLENAadolescent

Outcome Measures

Primary Outcomes (1)

  • MacArthur CDI

    MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores

    12 months

Secondary Outcomes (2)

  • LENA Counts

    birth, 4 months, 12 months

  • Ages & Stages Questionnaire

    4 months, 12 months

Study Arms (2)

Language Intervention

EXPERIMENTAL

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: 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 Participants receive a book at each interaction.

Behavioral: Teaching TalkingBehavioral: LENA recordings-languageBehavioral: Mastering MovementBehavioral: Language text messagesBehavioral: Motor text messages

Motor Control

ACTIVE COMPARATOR

1. Baseline LENA recording 2. Review motor curriculum with study personnel 3. 2nd LENA recording completed and analyzed 4. 4- monthly text messages 5. 4 month LENA recording 6. 12 month LENA recording with mailed linguistic feedback of all recordings 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 Participants receive a toy at each interaction.

Behavioral: LENA recordings-motorBehavioral: Mastering MovementBehavioral: Motor text messages

Interventions

Teaching TalkingBEHAVIORAL

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.

Language Intervention
LENA recordings-languageBEHAVIORAL

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.

Language Intervention
LENA recordings-motorBEHAVIORAL

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.

Motor Control
Mastering MovementBEHAVIORAL

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 InterventionMotor Control
Language text messagesBEHAVIORAL

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

Language Intervention
Motor text messagesBEHAVIORAL

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

Language InterventionMotor Control

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Infants ≥30 weeks born to 15-20 year old mothers

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 22007020BACKGROUND

  • 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.

    PMID: 9212550BACKGROUND

  • 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).

    PMID: 17329675BACKGROUND

MeSH Terms

Conditions

Adolescent BehaviorLanguage Development DisordersLanguage

Condition Hierarchy (Ancestors)

BehaviorLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCommunication

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Random assignment to language (intervention) or motor (control) focused curriculums
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 6, 2018

Study Start

January 25, 2013

Primary Completion

November 1, 2015

Study Completion

February 1, 2018

Last Updated

June 6, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

IPD will not be made available to other researchers