Newborn Implementation

• ClinicalTrials.gov Identifier: NCT03366831
• Recruitment Status: Completed
• First Posted: December 8, 2017
• Last Update Posted: December 19, 2019
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Study Description

Brief Summary:

The purpose of the proposed research is to perform testing of the Thirty Million Words Newborn Initiative (TMW-NI) with the primary goal of evaluating various implementation methods.

The investigators hypothesize that the TMW-Newborn intervention will:

1. Significantly impact parent knowledge regarding the importance of universal newborn hearing screen (UNHS) follow-up

2. Significantly impact parent knowledge of child development

   Additionally,the investigators hypothesize that:

3. The 7-minute version of the video with questions interspersed will most significantly improve parent knowledge of child development
4. There will be no significant differences in effectiveness of the Spanish and English versions of the TMW-Newborn intervention

The hypotheses rely on the existing research data supporting the idea that parental understanding and beliefs will alter parental behavior, and consequently, that increased parental linguistic input will impact child cognitive development.

Condition or disease	Intervention/treatment	Phase
Language Development	Behavioral: Thirty Million Words Initiative Newborn Intervention	Not Applicable

Detailed Description:

The investigators propose to perform a randomized implementation trial to evaluate the efficacy of various implementation methods of the TMW-Newborn educational intervention. The study will be conducted in temporal proximity to the administration of the universal newborn hearing screen.

After routine delivery, postpartum mothers are admitted to the mother-baby unit for 48-72 hours. A hearing screening technician of the Sacred Heart Hospital will deliver the tablet that houses the intervention to every mother whose child is receiving the hearing screening. The technician will give each mother a tablet set up to the HIPAA Compliant TMW-Newborn Web Platform that houses the randomization tool, the welcome video, the tablet based consent passage, the surveys, and the educational intervention videos. First, the participant will watch the welcome video and complete the tablet based consent. Then, the participant will be randomized into one of four conditions: 15 minute version of the TMW-Newborn intervention video without questions interspersed, the 15 minute version of the TMW-Newborn intervention video with questions interspersed, the 7 minute version of the TMW-Newborn intervention video without questions interspersed, or the 7 minute version of the TMW-Newborn intervention video with questions interspersed.

After randomization, the participant will be brought to the screen with the SPEAK III to complete. Then, they will answer a few non-identifying demographics questions. These surveys takes approximately 10 minutes to complete will be followed by either a 15-minute or 7-minute video.

After watching their assigned video, all participants will repeat the SPEAK questionnaire for a second time. Then, the hearing screener will pick up the tablet from the participant. No identifying information is being collected within the TMW-Newborn web platform, and the hearing screening technicians will not be able to see or access any of the participants' responses.

After all surveys are complete, the hearing screening technician will pick up the tablet from the participant and answer any remaining questions.

This study protocol will only be used at Sacred Heart Hospital, Baptist Hospital, and University of Chicago Hospital.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2701 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Thirty Million Words Initiative Newborn Implementation Trial
• Actual Study Start Date: April 10, 2017
• Actual Primary Completion Date: November 6, 2019
• Actual Study Completion Date: November 6, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 15 minute version without questions; 15 minute version of the TMW-Newborn intervention video without questions interspersed	Behavioral: Thirty Million Words Initiative Newborn Intervention; The Thirty Million Words Initiative Newborn Intervention (TMW-Newborn) is a public health effort aimed at increasing awareness about the importance of a child's early language environment in his or her first years of life. This one-time educational intervention will be impacting maternal awareness and knowledge about the importance of children's early language environment, between ages 0 and 3.
Active Comparator: 15 minute version with questions; 15 minute version of the TMW-Newborn intervention video with questions interspersed	Behavioral: Thirty Million Words Initiative Newborn Intervention; The Thirty Million Words Initiative Newborn Intervention (TMW-Newborn) is a public health effort aimed at increasing awareness about the importance of a child's early language environment in his or her first years of life. This one-time educational intervention will be impacting maternal awareness and knowledge about the importance of children's early language environment, between ages 0 and 3.
Active Comparator: 7 minute version without questions; 7 minute version of the TMW-Newborn intervention video without questions interspersed	Behavioral: Thirty Million Words Initiative Newborn Intervention; The Thirty Million Words Initiative Newborn Intervention (TMW-Newborn) is a public health effort aimed at increasing awareness about the importance of a child's early language environment in his or her first years of life. This one-time educational intervention will be impacting maternal awareness and knowledge about the importance of children's early language environment, between ages 0 and 3.
Active Comparator: 7 minute version with questions; 7 minute version of the TMW-Newborn intervention video with questions interspersed.	Behavioral: Thirty Million Words Initiative Newborn Intervention; The Thirty Million Words Initiative Newborn Intervention (TMW-Newborn) is a public health effort aimed at increasing awareness about the importance of a child's early language environment in his or her first years of life. This one-time educational intervention will be impacting maternal awareness and knowledge about the importance of children's early language environment, between ages 0 and 3.

Outcome Measures

Primary Outcome Measures :

1. SPEAK Survey (Baby Subscales) [ Time Frame: 48-72 after routine delivery ]
   measures an individuals expectations and knowledge about child development

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: new mothers
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

New mothers at Sacred Heart Hospital, University of Chicago Medical Center, and Baptist Hospital-Pensacola.

Exclusion Criteria:

Individuals that do not have a live birth at Sacred Heart Hospital, University of Chicago Medical Center, or Baptist Hospital-Pensacola or do not receive the UNHS at one of these locations will not be eligible for this study.

Contacts and Locations

Locations

United States, Florida

Sacred Heart Hospital

Pensacola, Florida, United States, 19141

Baptist Hospital

Pensacola, Florida, United States, 32501

United States, Illinois

TMW Center for Early Learning + Public Health at the University of Chicago Medicine

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

  Study Documents (Full-Text)

Documents provided by University of Chicago:

Study Protocol and Statistical Analysis Plan  [PDF] March 5, 2018

More Information

Additional Information:

Click here for more information about the Thirty Million Words 

Publications:

Suskind DL, Leung CYY, Webber RJ, Hundertmark AC, Leffel KR, Fuenmayor Rivas IE, Grobman WA. Educating Parents About Infant Language Development: A Randomized Controlled Trial. Clin Pediatr (Phila). 2018 Jul;57(8):945-953. doi: 10.1177/0009922817737079. Epub 2017 Oct 26.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT03366831
• Other Study ID Numbers: 17-0329
• First Posted: December 8, 2017
• Last Update Posted: December 19, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: IPD will not be shared

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No