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Developmental Intervention for Infants of Adolescent Mothers

Primary Purpose

Development, Child, Adolescent Behavior, Language Development

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Teaching Talking
LENA recordings-language
LENA recordings-motor
Mastering Movement
Language text messages
Motor text messages
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Development, Child focused on measuring language, LENA, adolescent

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Language Intervention

    Motor Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    MacArthur CDI
    MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores

    Secondary Outcome Measures

    LENA Counts
    Adult word counts, conversational turns and infant vocalization of each LENA recording
    Ages & Stages Questionnaire
    Parent report of development at 4 and 12 months of age

    Full Information

    First Posted
    May 24, 2018
    Last Updated
    May 24, 2018
    Sponsor
    Women and Infants Hospital of Rhode Island
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03547492
    Brief Title
    Developmental Intervention for Infants of Adolescent Mothers
    Official Title
    Developmental Intervention for Infants of Adolescent Mothers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 25, 2013 (Actual)
    Primary Completion Date
    November 1, 2015 (Actual)
    Study Completion Date
    February 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Women and Infants Hospital of Rhode Island

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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: Review language curriculum and motor curriculum with study personnel Direct linguistic feedback of baseline LENA recording 2nd LENA recording completed and analyzed Direct or mailed linguistic feedback of 2nd LENA recording 16- Weekly text messages 4 month LENA recording with mailed linguistic feedback 12 month LENA recording with mailed linguistic feedback Control: 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 Both groups undergo the following 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Development, Child, Adolescent Behavior, Language Development, Language Delay
    Keywords
    language, LENA, adolescent

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Random assignment to language (intervention) or motor (control) focused curriculums
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    108 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Language Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Motor Control
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Teaching Talking
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    LENA recordings-language
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    LENA recordings-motor
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mastering Movement
    Intervention Description
    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...
    Intervention Type
    Behavioral
    Intervention Name(s)
    Language text messages
    Intervention Description
    12 weekly text messages. Each is 1-2 sentences to review concepts of Teaching Talking
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motor text messages
    Intervention Description
    4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement
    Primary Outcome Measure Information:
    Title
    MacArthur CDI
    Description
    MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    LENA Counts
    Description
    Adult word counts, conversational turns and infant vocalization of each LENA recording
    Time Frame
    birth, 4 months, 12 months
    Title
    Ages & Stages Questionnaire
    Description
    Parent report of development at 4 and 12 months of age
    Time Frame
    4 months, 12 months

    10. Eligibility

    Sex
    All
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be made available to other researchers
    Citations:
    PubMed Identifier
    22007020
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9212550
    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. doi: 10.1093/jpepsy/22.3.313.
    Results Reference
    background
    PubMed Identifier
    17329675
    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. doi: 10.1044/1058-0360(2007/007).
    Results Reference
    background

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    Developmental Intervention for Infants of Adolescent Mothers

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