Developmental Intervention for Infants of Adolescent Mothers

NCT ID: NCT03547492

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-25

Study Completion Date

2018-02-01

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:

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

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Development, Child Adolescent Behavior Language Development Language Delay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Random assignment to language (intervention) or motor (control) focused curriculums
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Language Intervention

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.

Group Type EXPERIMENTAL

Teaching Talking

Intervention Type 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

Intervention Type 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.

Mastering Movement

Intervention Type 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

Intervention Type BEHAVIORAL

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

Motor text messages

Intervention Type BEHAVIORAL

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

Motor Control

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.

Group Type ACTIVE_COMPARATOR

LENA recordings-motor

Intervention Type 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

Intervention Type 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...

Motor text messages

Intervention Type BEHAVIORAL

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

Interventions

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Teaching Talking

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.

Intervention Type BEHAVIORAL

LENA recordings-language

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.

Intervention Type BEHAVIORAL

LENA recordings-motor

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.

Intervention Type BEHAVIORAL

Mastering Movement

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...

Intervention Type BEHAVIORAL

Language text messages

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

Intervention Type BEHAVIORAL

Motor text messages

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

Intervention Type BEHAVIORAL

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 22007020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9212550 (View on PubMed)

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).

Reference Type BACKGROUND
PMID: 17329675 (View on PubMed)

Other Identifiers

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IRB Net ID 792482-3

Identifier Type: -

Identifier Source: org_study_id

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