Developmental Intervention for Infants of Adolescent Mothers
NCT ID: NCT03547492
Last Updated: 2018-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
108 participants
INTERVENTIONAL
2013-01-25
2018-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
NCT00110292
Using the LENA System in Early Intervention - b
NCT03480841
Working on Rapid Language Development in Toddlers
NCT01975922
Developmental Monitoring and Language Promotion
NCT03732911
Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment
NCT07132411
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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
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.
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...
Motor text messages
4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Non-English speaking mothers
* No cell phone
* Mother not available for follow-up
* State custody of mother or infant.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Women and Infants Hospital of Rhode Island
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
References
Explore related publications, articles, or registry entries linked to this study.
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).
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB Net ID 792482-3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.