Clinical trial NCT03887832: Small Moments Big Impact (SMBI)
Official title: Small Moments, Big Impact; Supporting Maternal Empathy by Adding Media to Child Health Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Empathy
Keywords: child development
maternal empathy
digital media-based pediatric intervention
small moments, big impact (SMBI)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in perspective-taking assessed with the Interpersonal Reactivity Index
timeFrame: baseline, 6 months
measure: Change in empathetic concern assessed with the Interpersonal Reactivity Index
timeFrame: baseline, 6 months
measure: Parent-infant interactions assessed with ORCE
timeFrame: 6 months
Secondary outcomes:
measure: Change in maternal reflective functioning
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Barry Zuckerman, MD
role: PRINCIPAL_INVESTIGATOR
References: