Social IsolationNOWNCT02622399
Mobilizing Community Networks to Optimize Child Well-being
A study testing Project NOW in people with Social Isolation, run by Boston Medical Center at 1 site in United States.
Trial summary
Caregiver social isolation adversely impacts child health and developmental outcomes; it also contributes to suboptimal engagement in health care services and enrichment resources, which also elevate risk for poor outcomes in childhood. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Isolation
- What is being tested?
- Project NOW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 1 Jun 2017
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be a parent or primary caregiver for child five years or younger
- Participant has a smart phone that is text message and web enabled
- Participant resides in the Dorchester, Mattapan, or Roxbury neighborhoods of Boston, within the 02119, 02121, 02122, 02124, 02125, 02126 zip codes
- Fluent in English language
- Able to participate in English.
Who cannot join
- Does not have a smart phone or the ability to navigate a mobile application
- Participant does not reside Dorchester, Mattapan, or Roxbury neighborhoods of Boston, within the 02119, 02121, 02122, 02124, 02125, 02126 zip codes
- Not identified as a parent or caregiver of a child age five years old or younger
- Not identified as a parent or caregiver of a child age five years old or younger
Trial locations and contacts
1 site in 1 country.
About this study
Caregiver social isolation adversely impacts child health and developmental outcomes; it also contributes to suboptimal engagement in health care services and enrichment resources, which also elevate risk for poor outcomes in childhood. The proposed pilot intervention aims to reduce social isolation and promote engagement in health promoting enrichment and activities, by embedding a community health worker assisted forum in a community-driven mobile communications (using a platform supported by the company txtwire).
The investigators propose a two-arm, pilot study enrolling 100 parents of children age 0-5 years old who reside in the Roxbury, Dorchester, and Mattapan neighborhoods of Boston. Participants will be recruited from Boston Medical Center and community sites in Roxbury, Dorchester, and Mattapan. The investigators will use quality improvement methods to improve the utilization of the mobile communications shared through txtwire to build collective efficacy for children and social support and engagement that will optimize family resiliency and thereby promote child well-being, as well as, assess the acceptability of the intervention, and logistics of the field implementation to ultimately inform an appropriately powered RCT. Participants will receive compensation for participation at baseline and follow-up interviews.
The intent of this study is to support developement of mobile social communications to reduce social isolation.
Read the detailed description
The investigators propose a two-arm, pilot study enrolling 100 parents of children age 0-5 years old who reside in the Dudley Square neighborhood of Boston. Participants will be recruited from Boston Medical Center and community sites in Dudley Square. After completing the baseline survey, 50% of participants will be randomized to receive access to a free mobile communications and a web-based informational platform supported by txtwire. A simple randomization technique will be used.
The investigators will engage a group of community residents (who are not study participants) in the process of designing the social network content for the txtwire site and features.
The investigators will use quality improvement methods to improve the utilization of the txtwire mobile communications to improve social support and engagement that will optimize family resiliency and thereby promote child well-being, as well as, assess the acceptability of the intervention, and logistics of the field implementation to ultimately inform an appropriately powered RCT.
Recruitment will take place at Boston Medical Center in the outpatient pediatric primary care clinic and at public, community sites in Dorchester, Roxbury and Mattapan. The investigators will have a trained research assistant approach and recruit parents who are presenting for well-child care visits. The locations will be selected to maximize convenience for the families. A trained research assistant, following this standard procedure will screen parents presenting with a child between the ages of 0 and 5 years old for a routine health care maintenance visit from the clinical waiting areas at BMC and from public community sites.
Participants will be approached by a trained research assistant who will share a 1-page flyer about the study (see attached) and ask if they would like to proceed with the eligibility screening. For patients who meet inclusion/exclusion criteria, formal consent and contact information will be obtained. In order to proceed with the interview parents must agree to a follow-up interview in 6-months via phone or in-person.
Participants will be approached in the clinic waiting area at Boston Medical Center and in open community sites in the Dorchester, Roxbury, and Mattapan neighborhoods.
- First, the investigators will conduct a preliminary eligibility screen to determine participant eligibility using the criteria described below.
- Next, each participant will complete a contact information form that includes name, cell phone number, home address, and email address.
- Next, Each participant will complete a baseline survey.
After completing the baseline survey, the investigators will randomize 50% of participants to the intervention arm: the free txtwire social mobile communications. The investigators will randomize 100 caregivers with a child between the ages of 0-5 years old and have a primary residence in the Dorchester, Roxbury, or Mattapan neighborhoods of Boston. 50% of participants will be randomized to the free txtwire mobile communications. With the exception of cellphone number there will be no identifying data recorded by txtwire.
Subjects will be randomly allocated to study arms to eliminate unmeasured confounding. For those who consent, the investigators will randomize 1:1, according to a pre-made, concealed schedule. Subjects will be randomized to txtwire mobile communications or no intervention. Fifty caregivers in the intervention arm will receive a brief, in-person, training on how to use the txtwire mobile communications and assistance with setting it up on their mobile devices. Fifty caregivers will be randomized to the control arm. Members of the control arm will not receive any additional training or app. For both arms, the investigators will track engagement with community resources and services for child health and enrichment, social support and networks, and child and family well-being over a 6 month period using brief monthly electronic surveys completed on the mobile phone. These surveys will be administered using Mobile Commons. At the end of the 6 month period all subjects will complete a follow-up survey. They will receive compensation for completion. If an in-person interview is not possible, the investigators will conduct a phone interview.
The investigators will meet with community members who are not study participants to receive feedback on the content, layout, txtwire platform.
The investigators will meet biweekly as a team with the Community Health Worker, Research Assistant, Dr. Boynton-Jarrett and data manager. Using the Institute for Healthcare Improvement's Model for Improvement Plan-Do-Study-Act (PDSA) methodology, the investigators will review the use of the txtwire mobile communications and attempt to improve functioning of the community health worker mediated forum in an iterative fashion. Intervention study participants will be able to provide feedback on the utility of information provided through the txtwire mobile communications using the online platform. The investigators will plan for a change in one facet of the intervention, implement that change (do), study whether the desired effect was achieved, and act to determine if further optimization is needed. The investigators hope to engage in two or three PDSA cycles during the intervention period.
The investigators will conduct a semi-structured qualitative interviews with our intervention subjects to better understand engagement with the txtwire mobile communications at the time of the follow-up survey. The investigators intend to use the qualitative interview techniques to understand attitudes, behaviors, and motivations for interacting with the system.
- Conditions
- Social Isolation
- Being tested
- Project NOW
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project NOWBehavioural
This intervention aims to reduce social isolation and promote engagement in health promoting enrichment and activities, by embedding a community health worker-assisted forum in a community-driven mobile communications through a private, secure, and confidential platform supported by txtwire. The principal innovation is harnessing both the behavioral change utility of a mobile health application and the social support potential of an online social network the investigators can deliver more timely and dynamic reinforcement to caregivers and social support more in rhythm with the pace of community events and stressors.
| Study group | Role | What they receive |
|---|---|---|
| Project NOW | Experimental | Participants in the intervention arm receive access to free mobile communications and a web-based informational platform supported by txtwire. Receives: Behavioral: Project NOW |
| Control | No intervention | Participants in the control arm do not receive access to the txtwire platform. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in social isolation
This will be measured by change in baseline to follow-up survey on measures of social isolation.
Measured: 6 months
Secondary outcomes (3)
Decrease in parental stress
These will be obtained via self-report and assessment of change between the baseline and follow-up survey.
Measured: 6 months
Increase in parental social support
These will be obtained via self-report and assessment of change between the baseline and follow-up survey.
Measured: 6 months
increase in parental knowledge of and use of community resources for child enrichment and well-being
These will be obtained via self-report and assessment of change between the baseline and follow-up survey.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start1 Aug 2015
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renee Boynton-Jarrett, Boston Medical Center
- Investigators
- Renee Boynton-Jarrett, MD, ScD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622399
- Sponsor's protocol ID
- H-33938
- Acronym
- NOW
- Status last verified
- Aug 2017
- First submitted
- 16 Nov 2015
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilizing Community Networks to Optimize Child Well-being
- ClinicalTrials.gov ID
- NCT02622399
- Acronym / sponsor ID
- NOW / H-33938
- Conditions
- Social Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 4 Dec 2015 (estimated)
- 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.
Caregiver social isolation adversely impacts child health and developmental outcomes; it also contributes to suboptimal engagement in health care services and enrichment resources, which also elevate risk for poor outcomes in childhood. The proposed pilot intervention aims to reduce social isolation and promote engagement in health promoting enrichment and activities, by embedding a community health worker assisted forum in a community-driven mobile communications (using a platform supported by the company txtwire).
The investigators propose a two-arm, pilot study enrolling 100 parents of children age 0-5 years old who reside in the Roxbury, Dorchester, and Mattapan neighborhoods of Boston. Participants will be recruited from Boston Medical Center and community sites in Roxbury, Dorchester, and Mattapan. The investigators will use quality improvement methods to improve the utilization of the mobile communications shared through txtwire to build collective efficacy for children and social support and engagement that will optimize family resiliency and thereby promote child well-being, as well as, assess the acceptability of the intervention, and logistics of the field implementation to ultimately inform an appropriately powered RCT. Participants will receive compensation for participation at baseline and follow-up interviews.
The intent of this study is to support developement of mobile social communications to reduce social isolation.
Detailed description
The investigators propose a two-arm, pilot study enrolling 100 parents of children age 0-5 years old who reside in the Dudley Square neighborhood of Boston. Participants will be recruited from Boston Medical Center and community sites in Dudley Square. After completing the baseline survey, 50% of participants will be randomized to receive access to a free mobile communications and a web-based informational platform supported by txtwire. A simple randomization technique will be used.
The investigators will engage a group of community residents (who are not study participants) in the process of designing the social network content for the txtwire site and features.
The investigators will use quality improvement methods to improve the utilization of the txtwire mobile communications to improve social support and engagement that will optimize family resiliency and thereby promote child well-being, as well as, assess the acceptability of the intervention, and logistics of the field implementation to ultimately inform an appropriately powered RCT.
Recruitment will take place at Boston Medical Center in the outpatient pediatric primary care clinic and at public, community sites in Dorchester, Roxbury and Mattapan. The investigators will have a trained research assistant approach and recruit parents who are presenting for well-child care visits. The locations will be selected to maximize convenience for the families. A trained research assistant, following this standard procedure will screen parents presenting with a child between the ages of 0 and 5 years old for a routine health care maintenance visit from the clinical waiting areas at BMC and from public community sites.
Participants will be approached by a trained research assistant who will share a 1-page flyer about the study (see attached) and ask if they would like to proceed with the eligibility screening. For patients who meet inclusion/exclusion criteria, formal consent and contact information will be obtained. In order to proceed with the interview parents must agree to a follow-up interview in 6-months via phone or in-person.
Participants will be approached in the clinic waiting area at Boston Medical Center and in open community sites in the Dorchester, Roxbury, and Mattapan neighborhoods.
- First, the investigators will conduct a preliminary eligibility screen to determine participant eligibility using the criteria described below.
- Next, each participant will complete a contact information form that includes name, cell phone number, home address, and email address.
- Next, Each participant will complete a baseline survey.
After completing the baseline survey, the investigators will randomize 50% of participants to the intervention arm: the free txtwire social mobile communications. The investigators will randomize 100 caregivers with a child between the ages of 0-5 years old and have a primary residence in the Dorchester, Roxbury, or Mattapan neighborhoods of Boston. 50% of participants will be randomized to the free txtwire mobile communications. With the exception of cellphone number there will be no identifying data recorded by txtwire.
Subjects will be randomly allocated to study arms to eliminate unmeasured confounding. For those who consent, the investigators will randomize 1:1, according to a pre-made, concealed schedule. Subjects will be randomized to txtwire mobile communications or no intervention. Fifty caregivers in the intervention arm will receive a brief, in-person, training on how to use the txtwire mobile communications and assistance with setting it up on their mobile devices. Fifty caregivers will be randomized to the control arm. Members of the control arm will not receive any additional training or app. For both arms, the investigators will track engagement with community resources and services for child health and enrichment, social support and networks, and child and family well-being over a 6 month period using brief monthly electronic surveys completed on the mobile phone. These surveys will be administered using Mobile Commons. At the end of the 6 month period all subjects will complete a follow-up survey. They will receive compensation for completion. If an in-person interview is not possible, the investigators will conduct a phone interview.
The investigators will meet with community members who are not study participants to receive feedback on the content, layout, txtwire platform.
The investigators will meet biweekly as a team with the Community Health Worker, Research Assistant, Dr. Boynton-Jarrett and data manager. Using the Institute for Healthcare Improvement's Model for Improvement Plan-Do-Study-Act (PDSA) methodology, the investigators will review the use of the txtwire mobile communications and attempt to improve functioning of the community health worker mediated forum in an iterative fashion. Intervention study participants will be able to provide feedback on the utility of information provided through the txtwire mobile communications using the online platform. The investigators will plan for a change in one facet of the intervention, implement that change (do), study whether the desired effect was achieved, and act to determine if further optimization is needed. The investigators hope to engage in two or three PDSA cycles during the intervention period.
The investigators will conduct a semi-structured qualitative interviews with our intervention subjects to better understand engagement with the txtwire mobile communications at the time of the follow-up survey. The investigators intend to use the qualitative interview techniques to understand attitudes, behaviors, and motivations for interacting with the system.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project NOW | Experimental | Behavioral: Project NOWParticipants in the intervention arm receive access to free mobile communications and a web-based informational platform supported by txtwire. |
| Control | No intervention | –Participants in the control arm do not receive access to the txtwire platform. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be a parent or primary caregiver for child five years or younger
- Participant has a smart phone that is text message and web enabled
- Participant resides in the Dorchester, Mattapan, or Roxbury neighborhoods of Boston, within the 02119, 02121, 02122, 02124, 02125, 02126 zip codes
- Fluent in English language
- Able to participate in English.
Key exclusion criteria (4 listed)
- Does not have a smart phone or the ability to navigate a mobile application
- Participant does not reside Dorchester, Mattapan, or Roxbury neighborhoods of Boston, within the 02119, 02121, 02122, 02124, 02125, 02126 zip codes
- Not identified as a parent or caregiver of a child age five years old or younger
- Not identified as a parent or caregiver of a child age five years old or younger
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 |
|---|---|---|
| Project NOWThis intervention aims to reduce social isolation and promote engagement in health promoting enrichment and activities, by embedding a community health worker-assisted forum in a community-driven mobile communications through a private, secure, and confidential platform supported by txtwire. The principal innovation is harnessing both the behavioral change utility of a mobile health application and the social support potential of an online social network the investigators can deliver more timely and dynamic reinforcement to caregivers and social support more in rhythm with the pace of community events and stressors. | Behavioural | Project NOW |
Primary outcome
Reduction in social isolation
Time frame: 6 months
This will be measured by change in baseline to follow-up survey on measures of social isolation.
3 secondary outcomes
Decrease in parental stress
Time frame: 6 months
Increase in parental social support
Time frame: 6 months
increase in parental knowledge of and use of community resources for child enrichment and well-being
Time frame: 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 28 Aug 2017.
- 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.
Renee Boynton-Jarrett, MD, ScD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project NOW in people with Social Isolation, 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 5 inclusion and 4 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 28 Aug 2017. 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?
Reduction in social isolation (time frame: 6 months). 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 28 Aug 2017.