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Development, ChildNCT03547492

Developmental Intervention for Infants of Adolescent Mothers

A study testing Teaching Talking, LENA recordings-language and LENA recordings-motor in people with Development, Child and Adolescent Behavior, run by Women and Infants Hospital of Rhode Island.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
Teaching Talking, LENA recordings-language and LENA recordings-motor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
No sites listed yet
Study dates
25 Jan 2013to 1 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

Who may be able to join

  • Infants ≥30 weeks born to 15-20 year old mothers

Who cannot join

  • 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.

About this study

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.

Read the 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
Being tested
Teaching Talking, LENA recordings-language, LENA recordings-motor, Mastering Movement, Language text messages
Keywords
language, LENA, adolescent
Medical subject headings
Adolescent Behavior, Language Development Disorders, Language

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teaching TalkingBehavioural

    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-languageBehavioural

    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-motorBehavioural

    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 MovementBehavioural

    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 messagesBehavioural

    12 weekly text messages. Each is 1-2 sentences to review concepts of Teaching Talking

  • Motor text messagesBehavioural

    4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement

Study groups in NCT03547492
Study groupRoleWhat they receive
Language InterventionExperimental1. 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.
Receives: Behavioral: Teaching Talking; Behavioral: LENA recordings-language; Behavioral: Mastering Movement; Behavioral: Language text messages; Behavioral: Motor text messages
Motor ControlActive comparator1. 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.
Receives: Behavioral: LENA recordings-motor; Behavioral: Mastering Movement; Behavioral: Motor text messages

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MacArthur CDI

    MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores

    Measured: 12 months

Secondary outcomes (2)

  1. LENA Counts

    Adult word counts, conversational turns and infant vocalization of each LENA recording

    Measured: birth, 4 months, 12 months

  2. Ages & Stages Questionnaire

    Parent report of development at 4 and 12 months of age

    Measured: 4 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start25 Jan 2013
  3. Primary completion1 Nov 2015
  4. Study completion1 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
Random assignment to language (intervention) or motor (control) focused curriculums
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03547492
Sponsor's protocol ID
IRB Net ID 792482-3
Status last verified
May 2018
First submitted
24 May 2018
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be made available to other researchers

Publications

  • 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.

    PubMed 22007020

  • 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.

    PubMed 9212550

  • 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).

    PubMed 17329675

Questions about this trial

What is this clinical trial studying?

A study testing Teaching Talking, LENA recordings-language and LENA recordings-motor in people with Development, Child and Adolescent Behavior, run by Women and Infants Hospital of Rhode Island.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MacArthur CDI (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03547492, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

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