Developmental Intervention for Infants of Adolescent Mothers

Adolescent Behavior Clinical Trial

Official title:

Developmental Intervention for Infants of Adolescent Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547492
• Other study ID #: IRB Net ID 792482-3
• Status: Completed
• Phase: N/A
• Start date: January 25, 2013
• Est. completion date: February 1, 2018

Study information

• Verified date: May 2018
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 1, 2018
• Est. primary completion date: November 1, 2015
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Development, Child
• Language Delay
• Language Development
• Language Development Disorders

Intervention

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.
• 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.
• 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.
• 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...
• Language text messages
12 weekly text messages. Each is 1-2 sentences to review concepts of Teaching Talking
• Motor text messages
4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MacArthur CDI	MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores	12 months
Secondary	LENA Counts	Adult word counts, conversational turns and infant vocalization of each LENA recording	birth, 4 months, 12 months
Secondary	Ages & Stages Questionnaire	Parent report of development at 4 and 12 months of age	4 months, 12 months