Small Moments Big Impact (SMBI)

NCT03887832 | Completed

• 1 other identifier: H-38334
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Conditions

Empathy

Keywords

child development; maternal empathy; digital media-based pediatric intervention; small moments, big impact (SMBI)

Outcome Measures

Primary Outcomes (3)

• Change in perspective-taking assessed with the Interpersonal Reactivity Index

  The Interpersonal Reactivity Index (IRI) was designed to assess empathy, defined as "the reactions of one individual to the observed experiences of another." It has 28 items using 5-point scales (A = does not describe me well to E = describes me very well). It has 4 sub-scales: fantasy which assesses the extent to which individuals identify with fictional characters; perspective-taking which assesses the extent to which individuals spontaneously (try to) adopt others' points of view; empathetic concern which assesses the extent of individuals' "feelings of warmth, compassion, and concern for others."; and personal distress which assesses the extent of individuals "feelings of anxiety and discomfort" as a result of "another's negative experience." Each of the 4 sub-scales has 7 items and scores range from 28 to 140.

  baseline, 6 months

• Change in empathetic concern assessed with the Interpersonal Reactivity Index

  The Interpersonal Reactivity Index (IRI) was designed to assess empathy, defined as "the reactions of one individual to the observed experiences of another." It has 28 items using 5-point scales (A = does not describe me well to E = describes me very well). It has 4 sub-scales: fantasy which assesses the extent to which individuals identify with fictional characters; perspective-taking which assesses the extent to which individuals spontaneously (try to) adopt others' points of view; empathetic concern which assesses the extent of individuals' "feelings of warmth, compassion, and concern for others."; and personal distress which assesses the extent of individuals "feelings of anxiety and discomfort" as a result of "another's negative experience." Each of the 4 sub-scales has 7 items and scores range from 28 to 140.

  baseline, 6 months

• Parent-infant interactions assessed with ORCE

  Parent-infant videotaped interactions will be assessed using the NICHD Observational Record of the Caregiving Environment (ORCE). Interactions are coded on 4 to 5-point scales including: (1) sensitivity/responsiveness to non-distress, (2) intrusiveness, (3) detachment/disengagement, (4) positive regard for the child, (5) sensitivity/responsiveness to distress, and child distress.

  6 months

Secondary Outcomes (1)

• Change in maternal reflective functioning

  baseline, 6 months

Study Arms (2)

SBSI intervention

EXPERIMENTAL

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.

Other: SMBI digital app; Behavioral: media package; Other: standard newborn and infant care

Infant standard of care

ACTIVE COMPARATOR

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

Other: standard newborn and infant care

Interventions

SMBI digital app OTHER

Digital platform on the smartphone for the media package

SBSI intervention

media package 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.

SBSI intervention

standard newborn and infant care OTHER

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

Infant standard of care; SBSI intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Mothers with substance abuse problems

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02116, United States

Location

MeSH Terms

Interventions

Infant Care

Intervention Hierarchy (Ancestors)

Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Barry Zuckerman, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: August 29, 2019
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)