NCT02622399

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

November 16, 2015

Last Update Submit

August 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in social isolation

    This will be measured by change in baseline to follow-up survey on measures of social isolation.

    6 months

Secondary Outcomes (3)

  • Decrease in parental stress

    6 months

  • Increase in parental social support

    6 months

  • increase in parental knowledge of and use of community resources for child enrichment and well-being

    6 months

Study Arms (2)

Project NOW

EXPERIMENTAL

Participants in the intervention arm receive access to free mobile communications and a web-based informational platform supported by txtwire.

Behavioral: Project NOW

Control

NO INTERVENTION

Participants in the control arm do not receive access to the txtwire platform.

Interventions

Project NOWBEHAVIORAL

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.

Project NOW

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Renee Boynton-Jarrett, MD, ScD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BMC Attending Physician

Study Record Dates

First Submitted

November 16, 2015

First Posted

December 4, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 28, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations