- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887832
Small Moments Big Impact (SMBI) (SMBI)
Small Moments, Big Impact; Supporting Maternal Empathy by Adding Media to Child Health Services
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02116
- Boston Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Digital platform on the smartphone for the 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.
Recommended standard pediatric primary care will be provided for infants up to 6 months.
|
Active Comparator: 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.
|
Recommended standard pediatric primary care will be provided for infants up to 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline, 6 months
|
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.
|
baseline, 6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in maternal reflective functioning
Time Frame: baseline, 6 months
|
The Parental Reflective Functioning Questionnaire (PRFQ-1) measures mothers' reflective functioning and contains 39 statements with instructions to rate each one according to a 7-point Likert scale from 1 ("strongly disagree") to 7 ("strongly agree"), with 4 representing "neutral" or "undecided."
The items were formulated to be scored according to three sub-scales: (a) one with high scores representing increased reflective functioning (eg.
"My child and I can feel differently about the same thing."),
(b) one with low scores representing increased reflective functioning (eg.
"My child knows when I am having a bad day and does things to make it worse."),
and (c) one with middle, or neutral, scores representing increased reflective functioning and scores at either extreme representing decreased reflective functioning (eg.
"When I get angry with my child, I always know the reason why.")
|
baseline, 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barry Zuckerman, MD, Boston Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-38334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Empathy
-
Peking UniversityNot yet recruiting
-
Virginia Commonwealth UniversityCompleted
-
Universidad Pontificia ComillasCompleted
-
National Taipei University of Nursing and Health...Shin Kong Wu Ho-Su Memorial HospitalCompleted
-
University of Paris 5 - Rene DescartesUniversity of Paris 13; University Paris 7 - Denis DiderotCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
KTO Karatay UniversityRecruiting
-
National Taipei University of Nursing and Health...Active, not recruitingAttitude | EmpathyTaiwan
Clinical Trials on SMBI digital app
-
University of AberdeenCancer Research UKCompletedMelanomaUnited Kingdom
-
Mayo ClinicMayo Clinic Clinic Center for Innovation; Mayo Clinic Center for Clinical and...CompletedCardiovascular Diseases | Smoking Cessation | Hypertension | Obesity | Diabetes | Physical Activity | Diet Modification | Pre Diabetes | Prevention | High Cholesterol
-
Royal Free Hospital NHS Foundation TrustUniversity College, LondonUnknownDepressive Disorder | Covid19 | Anxiety Disorders | Post Traumatic Stress Disorder
-
Tel-Aviv Sourasky Medical CenterOwlytics HealthcareRecruiting
-
WV Health Right, Inc.ViiV HealthcareNot yet recruiting
-
Healthcare Innovation Technology LabCurio Digital Therapeutics, Inc.Active, not recruitingPostPartum DepressionUnited States
-
Henning BliddalMedical University of Vienna; Eurostars; DAMANNot yet recruiting
-
University of PennsylvaniaUniversity of California, San FranciscoCompletedLung Transplant; ComplicationsUnited States
-
University of PittsburghMount Sinai Hospital, New YorkCompletedAnxiety | Irritable Bowel DiseaseUnited States
-
Closed Loop MedicineCompleted