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临床试验/NCT03547492
NCT03547492已完成不适用

Developmental Intervention for Infants of Adolescent Mothers

Women and Infants Hospital of Rhode Island0 个研究点目标入组 108 人开始时间: 2013年1月25日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
主要终点
MacArthur CDI
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Language Intervention

Experimental
  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.

干预措施: Teaching Talking (Behavioral)

Language Intervention

Experimental
  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.

干预措施: LENA recordings-language (Behavioral)

Language Intervention

Experimental
  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.

干预措施: Mastering Movement (Behavioral)

Language Intervention

Experimental
  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.

干预措施: Language text messages (Behavioral)

Language Intervention

Experimental
  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.

干预措施: Motor text messages (Behavioral)

Motor Control

Active Comparator
  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.

干预措施: LENA recordings-motor (Behavioral)

Motor Control

Active Comparator
  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.

干预措施: Mastering Movement (Behavioral)

Motor Control

Active Comparator
  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.

干预措施: Motor text messages (Behavioral)

结局指标

主要结局

MacArthur CDI

时间窗: 12 months

MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores

次要结局

  • LENA Counts(birth, 4 months, 12 months)
  • Ages & Stages Questionnaire(4 months, 12 months)

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Sponsor

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