Pilot Test of a Mobile Text Approach to Measurement and Feedback for Wraparound Care Coordination (SMART-Wrap)

December 6, 2024 updated by: 3-C Institute for Social Development

A Mobile Text Approach to Measurement and Feedback for Wraparound Care Coordination

This SBIR Phase I study will test the acceptability and feasibility of a novel measurement and feedback system tailored to Wraparound service model (WSM) for emotional disorders to produce a feasible, cost-efficient, and scalable software system to meet the pressing public health need for Measurement-based Care in care coordination for youth behavioral health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this SBIR is to test a novel mobile and text-based measurement and feedback system tailored to WSM. Investigators will recruit 10 care teams (50 care team members total: 10 managers/administrators, 10 supervisors, and 30 care coordinators), 30 caregivers, and 15 youth/young adults (14+ yo) with SED currently enrolled in WSM. Caregivers of minor children aged 5-17 and caregivers of young adults 18-26 will be invited to participate. However, only parents with youth aged 14-17 will be invited to consider participation for their children, as well, and young adults age 18-26 will have the opportunity to participate without a caregiver If a caregiver has multiple children enrolled in Wraparound, we will select one child to invite to participate. Of those eligible, investigators will select 30 caregivers and up to 15 youth/young adults (14+) that have access to a mobile device. These participants will be informed of the project by members of their care team and asked to complete a consent to contact if they are interested in learning more about the research study. Interested families will be asked to review consent materials and sign up online. Caregivers and youth/young adults will participate in a 30-minute study orientation meeting and then interact independently with the system over a 4-week period. During this time, care team members will have access to the SMART-Wrap website, where they can view the survey feedback from their families. Care team members will be expected to interact with the system throughout the test period and may adjust care based on the feedback they receive. Within 5 days of the last text message, caregivers and youth/young adults will complete a brief survey evaluating the prototype in the following areas of usability, acceptability, and feasibility, as well as complete the 10-item System Usability Survey (SUS). Care team members will complete a similar survey that asks about these same areas, but also includes items about compatibility with existing wraparound treatment planning and implementation, interoperability with existing electronic record management systems, duplicative vs. complementary with existing systems, and added value over existing methods. Following completion of their evaluation, participants will be invited to take part in 45-minute interviews or virtual focus groups (separately for care team members, caregivers, and youth/young adults). Of the participants that agree, 10 care team members, 10 caregivers, and 10 youth/young adults will be selected to complete the virtual focus group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • 3C Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Wraparound Service Model Care teams (each consisting of 1 manager or administrator, 1 supervisor, and up to 3 care coordinators) must coordinate the care of one youth/young adult (ages 5-26).
  • Wraparound Service Model enrolled families can consist of either (a) a caregiver of a youth/young adult age 5-26 (participating without their child), (b) a caregiver of a youth/young adult age 14-26 (participating with their child - adult children sign separate consent to contact forms and enroll separately), or (c) a young adult age 18-26 participating without their caregiver.

Exclusion Criteria:

  • youth/young adults known to providers to have expressed risk of harm to themselves or others within the 6 months prior to the recruitment period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SMART-Wrap
SMART-Wrap is a prototype measurement and feedback software system tailored to Wraparound service model (WSM) for emotional disorders to provide measurement-based care in care coordination for youth behavioral health.
Other: SMART-Wrap
This intervention, SMS (short message system)-based augmentation, seeks to improve the impact and approach of the Wraparound service model by utilizing SMS, which has been shown to increase treatment adherence and sustained engagement. This intervention will facilitate regular, repeated evaluation of intermediate outcomes through self-report assessments.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prototype Evaluation for Families
Time Frame: 5-week follow-up post messaging protocol
Caregivers, youth, and young adults will complete this 12-item measure, rating the extent to which they agree with statements about the usability, acceptability, and feasibility of the SMART-Wrap system. The measure includes 9 Likert items and 3 open-ended items. Responses to the Likert items range from 1 (Completely Disagree) to 5 (Completely Agree). Total scores are based on the Likert items are range from 0 to 45. Higher scores reflect more positive opinions.
5-week follow-up post messaging protocol
Prototype Evaluation for Care Team Members
Time Frame: 5-week follow-up post messaging protocol
Care team members will complete this 34-item measure, rating the extent to which they agree with statements about the SMART-Wrap system. The measure includes 7 open-ended items, one yes/no item, and 26 Likert-scale items about the usability, acceptability, and feasibility of the system, and items about the system's interoperability with existing electronic record management systems, whether it is duplicative or complementary with existing systems, and its added value over existing methods of collecting feedback from families in Wraparound. Responses to the Likert items range from 1 (Completely Disagree) to 5 (Completely Agree). Total scores are based on the Likert items and range from 0 to 130. Higher scores reflect more positive opinions.
5-week follow-up post messaging protocol
System Usability Survey
Time Frame: 5-week follow-up post messaging protocol
Caregivers, youth, young adults, and care team members will complete this 10-item measure, rating the extent to which they agree with statements about the usability of the SMART-Wrap system. Responses range from 1 (Completely Disagree) to 5 (Completely Agree). For items 1, 3, 5, 7, and 9, higher scores reflect more positive outcomes. For items 2, 4, 6, 8, and 10, higher scores reflect more negative outcomes. Items 2, 4, 6, 8, and 10 are reverse coded, and all survey items are rescaled from 0 to 4 and multiplied by 2.5 to calculate total scores, which range from 0 to 100.
5-week follow-up post messaging protocol

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Results from Caregiver Text Message Items
Time Frame: 4-item sets of survey items administered weekly over a 4-week period
Caregivers will complete this 16-item measure, rating the extent to which they agree with statements about therapeutic alliance with their Wraparound care team, their satisfaction with Wraparound, the care team's fidelity to the Wraparound care model, and their outcomes because of participating in Wraparound. Responses range from 0 (Not at All) to 4 (Absolutely). Total scores range from 0 to 64. Higher scores reflect greater satisfaction, therapeutic alliance, and fidelity and better outcomes.
4-item sets of survey items administered weekly over a 4-week period
Results from Youth Text Message Items
Time Frame: 2-item sets of surveys items administered weekly over a 4-week period
Youth and young adults will complete this 8-item measure, rating the extent to which they agree with statements about their satisfaction with Wraparound and their outcomes as a result of participating in Wraparound. Responses range from 0 (Not at All) to 4 (Absolutely). Total scores range from 0 to 32. Higher scores reflect greater satisfaction and better outcomes.
2-item sets of surveys items administered weekly over a 4-week period
Usage Metrics from the SMART-Wrap system for families
Time Frame: 4-week period
The SMART-Wrap software will track whether each text message is opened, the length of time between delivery and opening, and length of time between opening and submission of item response. These metrics are measured in seconds. In all cases, a shorter time span indicates more positive outcomes.
4-week period
Usage Metrics from the SMART-Wrap system for care team members
Time Frame: the period in which any families served by the care team are interacting with the SMART-Wrap system, approximately 8-weeks
The SMART-Wrap software will track usage of the SMART-Wrap dashboard by the care team, including number of logins, amount of time spent (in seconds), and number/type of technical assistance requests. Number of logins and number of technical requests are measured as counts. Higher numbers of logins indicates a more positive outcome, higher time spent indicates a more positive outcome, and lower number of technical requests represents a more positive outcome.
the period in which any families served by the care team are interacting with the SMART-Wrap system, approximately 8-weeks
Results from focus groups / interviews with families
Time Frame: 45-minutes, completed after the test of the SMART-Wrap system
10 caregivers and 10 youth/young adults will participate in either focus groups or individual interviews. They will be asked about their experience with the SMART-Wrap system, strengths and weaknesses of SMART-Wrap, and challenges to using SMART-Wrap. Comments will be combined and grouped based on themes in a qualitative summary.
45-minutes, completed after the test of the SMART-Wrap system
Results from focus groups / interviews with care team members
Time Frame: 45-minutes, completed after the test of the SMART-Wrap system
10 care team members will participate in either focus groups or individual interviews. They will be asked about strengths and weaknesses of SMART-Wrap, and challenges to using SMART-Wrap, and recommendations for revisions to SMART-Wrap. Comments will be combined and grouped based on themes in a qualitative summary.
45-minutes, completed after the test of the SMART-Wrap system

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
3-C Institute for Social Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melissa DeRosier, PhD, 3C Institute
  • Principal Investigator: Eric Bruns, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3CG079Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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