Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03547492
Other study ID # IRB Net ID 792482-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05071989 - The Influence of Sleep Education With Social Media Reminders on the Sleep Quality in Adolescents N/A
Recruiting NCT05064293 - Assisted Identification and Navigation of Early Mental Health Symptoms in Children N/A
Enrolling by invitation NCT05017779 - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth N/A
Completed NCT03685643 - Study Proposal for Web Based Intervention to Promote the Safe Usage of Dating Applications in Young Adults N/A
Completed NCT03270943 - The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Recruiting NCT05334381 - Navigating Mental Health Treatment for Black Youth N/A
Active, not recruiting NCT05926141 - Advanced Cooking Education Pilot Study N/A
Recruiting NCT04317547 - Translation Study of a Safe Teen Driving Intervention N/A
Recruiting NCT06001892 - Tennessee Youth Prepared for Success N/A
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Not yet recruiting NCT06310434 - Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes.
Not yet recruiting NCT05316948 - Mental Health and Sexuality in Adolescents and Young Adults
Completed NCT02683811 - Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2) N/A
Terminated NCT02578147 - JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls N/A
Active, not recruiting NCT02329015 - Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools Phase 1
Completed NCT03482687 - It's Your Game: An Innovative Approach to Preventing Teen Dating Violence N/A
Completed NCT01433679 - The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents N/A
Completed NCT00056953 - Peer Mentors for Adolescents in HIV Affected Families Phase 2