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Developmental Intervention for Infants of Adolescent Mothers

Women and Infants Hospital of Rhode Island logo

Women and Infants Hospital of Rhode Island

Status

Completed

Conditions

Development, Child
Language Development
Adolescent Behavior
Language Delay

Treatments

Behavioral: LENA recordings-language
Behavioral: LENA recordings-motor
Behavioral: Language text messages
Behavioral: Teaching Talking
Behavioral: Motor text messages
Behavioral: Mastering Movement

Study type

Interventional

Funder types

Other

Identifiers

NCT03547492
IRB Net ID 792482-3

Details and patient eligibility

About

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.

Full 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

Enrollment

108 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

108 participants in 2 patient groups

Language Intervention
Experimental group
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: 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.
Treatment:
Behavioral: Mastering Movement
Behavioral: LENA recordings-language
Behavioral: Language text messages
Behavioral: Teaching Talking
Behavioral: Motor text messages
Motor Control
Active Comparator group
Description:
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.
Treatment:
Behavioral: Mastering Movement
Behavioral: LENA recordings-motor
Behavioral: Motor text messages

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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