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Clinical Trials/NCT03887832
NCT03887832
Completed
Not Applicable

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

Boston Medical Center1 site in 1 country118 target enrollmentAugust 29, 2019
ConditionsEmpathy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Empathy
Sponsor
Boston Medical Center
Enrollment
118
Locations
1
Primary Endpoint
Change in perspective-taking assessed with the Interpersonal Reactivity Index
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 29, 2019
End Date
March 2, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in perspective-taking assessed with the Interpersonal Reactivity Index

Time Frame: baseline, 6 months

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.

Parent-infant interactions assessed with ORCE

Time Frame: 6 months

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.

Change in empathetic concern assessed with the Interpersonal Reactivity Index

Time Frame: baseline, 6 months

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.

Secondary Outcomes

  • Change in maternal reflective functioning(baseline, 6 months)

Study Sites (1)

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