Developmental Intervention for Infants of Adolescent Mothers

Not Applicable

Completed

• Conditions: Language Delay; Development, Child; Language Development; Adolescent Behavior
• Interventions: Behavioral: Teaching Talking; Behavioral: LENA recordings-motor; Behavioral: LENA recordings-language; Behavioral: Mastering Movement; Behavioral: Motor text messages; Behavioral: Language text messages

• Registration Number: NCT03547492
• Lead Sponsor: Women and Infants Hospital of Rhode Island

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:

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

Study Timeline

• Study Start: 2013-01-25
• Primary Completion: 2015-11-01
• Study Completion: 2018-02-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-05-24
• Last Update Submitted: 2018-05-24
• Study First Posted: 2018-06-06
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Language Intervention	Mastering Movement	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.
Language Intervention	Language text messages	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.
Language Intervention	Teaching Talking	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.
Motor Control	LENA recordings-motor	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.
Motor Control	Motor text messages	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.
Language Intervention	LENA recordings-language	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.
Language Intervention	Motor text messages	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.
Motor Control	Mastering Movement	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.

Primary Outcome Measures

Name	Time	Method
MacArthur CDI	12 months	MacArthur Bates Communicative Developmental Inventory: Words and Gestures scores

Secondary Outcome Measures

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