Small Moments Big Impact (SMBI)

NCT ID: NCT03887832

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-29
• Study Completion Date: 2021-03-02

Brief Summary

Empathy is defined as sensitivity to the needs of others.Maternal empathy, or a mother's sensitivity to the needs of her child, is critical for healthy child development ,Small Moments, Big Impact: Supporting Maternal Empathy by Adding Media to Child Health Services (SMBI) will develop and pilot a media-based pediatric primary care intervention that aims to answer two Big Questions: 1) Can media sent by pediatricians to mothers from low-income backgrounds promote empathy? 2) Is there a feasible and scalable approach? If successful, SMBI will result in: 1) increased maternal empathy; 2) new evidence and knowledge about an effective approach for supporting empathy in mothers from low-income backgrounds; 3) acceptability, feasibility of administering, and therefore potential for scalability through standard pediatric care; 4) increased support of maternal empathy as a core component of pediatric care; and 5) increased support by other stakeholders (including medical professionals, child health care facilities, and funders) to further explore, expand, and ultimately rollout the intervention

Detailed Description

This mixed methods research design will assess whether a digital media-based pediatric primary care intervention can increase empathy in mothers of newborns from low-income backgrounds compared to the current standard of care. During their newborns' stay in the nursery following recruitment, eligible mothers will be assigned to the intervention or comparison group. Mothers in the intervention group will download the SMBI smartphone app onto their phone and be trained by a research assistant (RA) on the functionality of the app. Mothers will be shown a video from the app, and shown how to share videos with others, to respond to prompts, and to rate the video. These activities represent what mothers are asked to do at home throughout the intervention. After departing the hospital, mothers in the intervention group will receive a media package (video, associated prompt/s, and activity) via the SMBI app every week for six months. Mothers will be asked to watch the videos, respond to the prompts, do the activities, and rate the value of videos via the SMBI app. Mothers will be encouraged to share questions and comments with the child's pediatrician and to share the videos with their support network. Mothers in the comparison group will receive the standard of care.

Mothers in both groups will be asked to complete a questionnaire at the end of recruitment and at 6 month visit and at the 6 month visit the investigators will also video tape and code a five minute play interaction. In addition, a focus group will be conducted with some mothers in the intervention group.

As of April 2020 in compliance with institutional COVID-19 policies all recruitment and interventions are being done without in-person contact.

Conditions

Empathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

SBSI intervention

Mothers is this arm will download the SMBI intervention app onto their smartphone. They will be shown a video from the app and how to share videos with others. After hospital discharge, mothers will receive a weekly media package (video, associated prompt(s), and activity) via the SMBI for six months.

Group Type: EXPERIMENTAL

SMBI digital app

Intervention Type: OTHER

Digital platform on the smartphone for the media package

media package

Intervention Type: BEHAVIORAL

The SMBI app contains a \<1 minute video of a mother and baby or just mother, a reflection question about the video, a few questions about their mood and stress, and some prompts and suggestions on what to do if they have problems.

standard newborn and infant care

Intervention Type: OTHER

Recommended standard pediatric primary care will be provided for infants up to 6 months.

Infant standard of care

Mothers in this arm will receive the standard of care for newborn and infants including education and a list of resources.

Group Type: ACTIVE_COMPARATOR

standard newborn and infant care

Intervention Type: OTHER

Recommended standard pediatric primary care will be provided for infants up to 6 months.

Interventions

SMBI digital app

Digital platform on the smartphone for the media package

Intervention Type: OTHER

media package

The SMBI app contains a \<1 minute video of a mother and baby or just mother, a reflection question about the video, a few questions about their mood and stress, and some prompts and suggestions on what to do if they have problems.

Intervention Type: BEHAVIORAL

standard newborn and infant care

Recommended standard pediatric primary care will be provided for infants up to 6 months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult mothers with a singleton baby born at term without any significant medical problems
• Mothers who plan to obtain pediatric care at BMC
• Mothers who are English speaking and reading
• Mothers who have a smartphone (data plan will be supplied if needed)

Exclusion Criteria

-Mothers with substance abuse problems

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry Zuckerman, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-38334

Identifier Type: -

Identifier Source: org_study_id