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.

Study Overview

• Status: Completed
• Conditions: Adolescent Behavior; Language Development; Development, Child; Language Delay
• Intervention / Treatment: Behavioral: Teaching Talking; Behavioral: LENA recordings-language; Behavioral: Mastering Movement; Behavioral: Language text messages; Behavioral: Motor text messages; Behavioral: LENA recordings-motor

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

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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: 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; 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.; 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.; 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...; Behavioral: Language text messages; 12 weekly text messages. Each is 1-2 sentences to review concepts of Teaching Talking; Behavioral: Motor text messages; 4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement
ACTIVE_COMPARATOR: Motor Control; 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: 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...; Behavioral: Motor text messages; 4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island

Publications and helpful links

General Publications

• 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.
• 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.
• 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).

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2013
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): February 1, 2018

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (ACTUAL): June 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2018
• Last Update Submitted That Met QC Criteria: May 24, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: adolescent; language; LENA
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Language Development Disorders
• Other Study ID Numbers: IRB Net ID 792482-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be made available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No