Clinical Trials Directory

Trials / Completed

CompletedNCT03887832

Small Moments Big Impact (SMBI)

Small Moments, Big Impact; Supporting Maternal Empathy by Adding Media to Child Health Services

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
118 (actual)
Sponsor
Boston Medical Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERSMBI digital appDigital platform on the smartphone for the media package
BEHAVIORALmedia packageThe 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.
OTHERstandard newborn and infant careRecommended standard pediatric primary care will be provided for infants up to 6 months.

Timeline

Start date
2019-08-29
Primary completion
2021-03-02
Completion
2021-03-02
First posted
2019-03-25
Last updated
2021-03-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03887832. Inclusion in this directory is not an endorsement.