NCT05743712

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 1, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

February 7, 2023

Last Update Submit

December 6, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Prototype Evaluation for Families

    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

    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

    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 Outcomes (6)

  • Results from Caregiver Text Message Items

    4-item sets of survey items administered weekly over a 4-week period

  • Results from Youth Text Message Items

    2-item sets of surveys items administered weekly over a 4-week period

  • Usage Metrics from the SMART-Wrap system for families

    4-week period

  • Usage Metrics from the SMART-Wrap system for care team members

    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

    45-minutes, completed after the test of the SMART-Wrap system

  • +1 more secondary outcomes

Study Arms (1)

SMART-Wrap

EXPERIMENTAL

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

Interventions

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.

SMART-Wrap

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3C Institute

Durham, North Carolina, 27713, United States

Location

Study Officials

  • Melissa DeRosier, PhD

    3C Institute

    PRINCIPAL INVESTIGATOR
  • Eric Bruns, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 24, 2023

Study Start

February 1, 2023

Primary Completion

November 20, 2023

Study Completion

January 31, 2024

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations