EmpathySMBINCT03887832
Small Moments Big Impact (SMBI)
A study testing SMBI digital app, media package and standard newborn and infant care in people with Empathy, run by Boston Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Empathy
- What is being tested?
- SMBI digital app, media package and standard newborn and infant care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2019to 2 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- -Mothers with substance abuse problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Small Moments, Big Impact; Supporting Maternal Empathy by Adding Media to Child Health Services
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
Read the 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
- Empathy
- Being tested
- SMBI digital app, media package, standard newborn and infant care
- Keywords
- child development, maternal empathy, digital media-based pediatric intervention, small moments, big impact (SMBI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMBI digital appOther
Digital platform on the smartphone for the media package
media packageBehavioural
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.
standard newborn and infant careOther
Recommended standard pediatric primary care will be provided for infants up to 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: standard newborn and infant care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Change in maternal reflective functioning
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.")
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start29 Aug 2019
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barry Zuckerman, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887832
- Sponsor's protocol ID
- H-38334
- Acronym
- SMBI
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2019
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Moments, Big Impact; Supporting Maternal Empathy by Adding Media to Child Health Services
- ClinicalTrials.gov ID
- NCT03887832
- Acronym / sponsor ID
- SMBI / H-38334
- Conditions
- Empathy
- Keywords
- child development, maternal empathy, digital media-based pediatric intervention, small moments, big impact (SMBI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBSI intervention | Experimental | Other: SMBI digital app, Behavioral: media package, Other: standard newborn and infant careMothers 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. |
| Infant standard of care | Active comparator | Other: standard newborn and infant careMothers in this arm will receive the standard of care for newborn and infants including education and a list of resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- -Mothers with substance abuse problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMBI digital appDigital platform on the smartphone for the media package | Other | SBSI intervention |
| media 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. | Behavioural | SBSI intervention |
| standard newborn and infant careRecommended standard pediatric primary care will be provided for infants up to 6 months. | Other | Infant standard of care, SBSI intervention |
Primary outcome
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.
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.
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.
1 secondary outcome
Change in maternal reflective functioning
Time frame: baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Zuckerman, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMBI digital app, media package and standard newborn and infant care in people with Empathy, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perspective-taking assessed with the Interpersonal Reactivity Index (time frame: baseline, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.