Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Developmental Intervention for Infants of Adolescent Mothers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547492
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Women and Infants Hospital of Rhode Island

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Development, Child Adolescent Behavior Language Development Language Delay Behavioral: Teaching Talking Behavioral: LENA recordings-language Behavioral: LENA recordings-motor Behavioral: Mastering Movement Behavioral: Language text messages Behavioral: Motor text messages Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Random assignment to language (intervention) or motor (control) focused curriculums
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Developmental Intervention for Infants of Adolescent Mothers
Actual Study Start Date : January 25, 2013
Actual Primary Completion Date : November 1, 2015
Actual Study Completion Date : February 1, 2018
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

  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 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
  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-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.

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. MacArthur CDI [ Time Frame: 12 months ]
    MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores


Secondary Outcome Measures :
  1. LENA Counts [ Time Frame: birth, 4 months, 12 months ]
    Adult word counts, conversational turns and infant vocalization of each LENA recording

  2. Ages & Stages Questionnaire [ Time Frame: 4 months, 12 months ]
    Parent report of development at 4 and 12 months of age


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT03547492    
Other Study ID Numbers: IRB Net ID 792482-3
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be made available to other researchers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Women and Infants Hospital of Rhode Island:
language
LENA
adolescent
Additional relevant MeSH terms:
Layout table for MeSH terms
Language Development Disorders
Language Disorders
Communication Disorders
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases