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

NCT07300930 | Not Yet Recruiting

• 2 other identifiers: SMARTwrap PII2R44MH126793-03
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

This SBIR Phase II proposal will fully develop and test the acceptability, feasibility, and efficacy of a novel measurement and feedback system, SMART-Wrap, tailored to Wraparound service model (WSM) for youth with serious emotional disorders (SED). SMART-Wrap will be 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. Results from pilot testing will determine SMART-Wrap's feasibility, usability, and efficacy in improving care quality and family outcomes, in addition to preparing the product for commercialization.

Conditions

Mental Health Services; Mobile Technologies; Technology Development

Outcome Measures

Primary Outcomes (30)

• Short Message Service (SMS) Outreach - Caregiver

  Caregiver Short Message Service (SMS) outreach includes 27 self-report Likert items (4 pt scale- 0= Not at all to 3= Absolutely) capturing feedback on six different themes (Therapeutic Alliance, Wraparound Fidelity, Satisfaction with Care, Making Progress, Caregiver and Family Outcomes, and Youth Outcomes). Caregivers will be asked to complete 4 items from the bank of 27, each week over the course of 16 weeks. Items will be resampled across the 4-month interval with 64 items being delivered. A mean score will be computed. SMS score means will range from 0 to 3 and lower scores indicate increased Wraparound needs.

  Weekly, ongoing for 4 months

• Short Message Service (SMS) Open Rate (SMARTWrap open rate) - Caregiver

  Short Message Service (SMS) open rate will be calculated from the 16 SMS's that are delivered. Rates will be computed as percentage opened (0-100%) and higher rates indicated more consistent system usage.

  ongoing, over a 4-month period

• Item Completion Rate (SMARTWrap item completion rate) - Caregiver

  Item completion rate will be calculated from the 64 items that are delivered. Rates will be computed as percentages (0-100%) and higher rates indicated more consistent item completion.

  ongoing, over a 4-month period

• Time to Complete (SMARTWrap time) - Caregiver

  Time to complete the 16 SMS delivered surveys will be calculated and reported as a mean in seconds ranging from 0 to 600, with higher scores showing longer completion times.

  ongoing, over a 4-month period

• SMART-Wrap User Survey - Caregiver

  The SMART-Wrap User Survey-Caregiver version is a 15-item study team developed survey to evaluate "real world" user perceptions of SMART-Wrap. Items will focus on the user experience of the Caregiver. The items will be scored using a 5-pt Likert scale (1- Strongly disagree to 5- Strongly Agree). Items will be summed and a mean computed (range 1 to 5) and higher scores indicating higher usability.

  4-month

• SMART-Wrap System Usability Scale - Caregiver

  The System Usability Scale (SUS) is a widely used 10-item measure of usability considered highly sensitive and robust. Items will be completed using a 5-pt Likert scale (0- Strongly disagree to 4- Strongly Agree). The sum of the scores is multiplied by 2.5 to derive the final score. Scores range from 0-100: \<50 indicates unacceptable usability, 50-70 marginal, and \>70 indicating acceptable.

  4-month

• Monthly Caregiver Report (MPR) - Caregiver

  Caregivers will report via 5-item monthly survey related to use of data in treatment, e.g., reviewed plan with care coordinator (CC), problem-solved concerns with CC, reviewed data, revised treatment goals and/or strategies, contracted by CC about concerns. Ratings will be completed using a 4-pt Likert scale (0= Not at all to 3= Absolutely). Scores will be summed and a mean computed (range 0 to 3) and higher scores indicating greater report of data used in treatment.

  Baseline, 1-month, 2-month, 3-month, 4-month

• Working Alliance Inventory- Short Revised (WAI-SR) - Caregiver

  The Working Alliance Inventory-Short Revised (WAI-SR) is a widely used rating scale designed to measure the working alliance between counselors and clients. Both versions have 12 5-point Likert items covering three domains: bond, goals, and tasks. As done in previous studies by the investigators, the WAI will be revised to reflect alliance between the Care Team and family. Scores range from 12 to 60, with higher scores indicating better alliance.

  4-month

• The Parent Satisfaction Scales - Caregiver

  The Parent Satisfaction Scales reliably measure five dimensions of satisfaction, each with 1 Likert scale item, including: (1) access and convenience, (2) child's treatment process and relationship with providers,(3) parent and family services, (4) satisfaction with progress, and (5) global satisfaction. Respondents rate each statement using a 4-point Likert scale (1-No, Definitely Not to 4-Yes, definitely). The responses are summed, and then an average is calculated (range 1 to 4). A higher score indicates greater satisfaction with services.

  4-month

• Top Problem Assessment (TPA) - Caregiver

  The Top Problem Assessment (TPA) is a consumer-focused index of the severity of the top three problems nominated by the caregiver, on a scale of 0-10. The three ratings are combined (range 0-30) and a higher score indicates higher perceived problems. TPA has good reliability and validity and sensitivity to treatment changes.

  Baseline, 1-month, 2-month, 3-month, 4-month

• Brief Problem Checklist (BPC) - Caregiver

  The Brief Problem Checklist (BPC) is a 12-item checklist of internalizing and, externalizing, rated on a 2-pt Likert scale (0-Not true to 2-Very true). Scores are summed (range 0-24) and higher scores indicate more problem behaviors.

  Baseline, 4-month

• Caregiver Strain Questionnaire (CGSQ) - Caregiver

  The Caregiver Strain Questionnaire (CGSQ) is a 21-item measure of the parent/caregiver's stress related to caregiving for a youth with emotional problems. Responses are made on a 5-point Likert Scale (0- Not at all to 4- Very much). Scores range from 0 to 84 and higher scores indicate greater caregiver strain.

  Baseline, 4-month

• Wraparound Fidelity Index Brief Version WFI-EZ - Caregiver

  The Wraparound Fidelity Index Brief Version (WFI-EZ) is a widely used 25-item self-report measure using a 5-pt Likert scale (0-strongly disagree to 4-strongly agree) that assesses fidelity to the Wraparound process. Research shows the WFI-EZ is reliable, valid, and discriminates against groups with differing support to WSM implementation. Scores range from 0 to 100, with higher scores indicating better satisfaction.

  4-month

• WSM Attrition and Dropout - Caregiver

  Attrition and dropout will be indexed by project staff through chart review. Each family will receive a rating of 0- Dropped out of Care/ Lost to Attrition, or 1- Participated in Care for each week of the 4 month study period. Scores will range from 0 to 16 and higher scores indicating persistent treatment.

  4-month

• WSM Attendance - Caregiver

  Attendance will be indexed by project staff through chart review, using a standard checklist to tally: team meetings, service encounters, therapy events, no shows and cancellations. For each attended event, 1 point will be assigned. For each, cancellation or no show, 1 point will be deducted. The range of scores will be based on participant behavior and higher scores indicating more robust program participation.

  4-month

• Short Message Service (SMS) Outreach - Youth

  Youth Short Message Service (SMS) outreach includes 20 self-report Likert items (4 pt scale- 0= Not at all to 3= Absolutely) capturing feedback on six different themes (Therapeutic Alliance, Wraparound Fidelity, Satisfaction with Care, Making Progress, Caregiver and Family Outcomes, and Youth Outcomes). Youth will be asked to complete 3 items from the bank of 20, each week. Items will be resampled across the 4-month interval with 48 items being delivered. A mean score will be computed. SMS score means will range from 0 to 3 and lower scores indicate increased Wraparound needs.

  Weekly, ongoing for 4-months

• WSM Attrition and Dropout - Youth

  Attrition and dropout will be indexed by project staff through chart review. Each family will receive a rating of 0- Dropped out of Care/ Lost to Attrition, or 1- Participated in care for each week of the 4 month study period. Scores will range from 0 to 16 and higher scores indicating persistent treatment.

  4-month

• WSM Attendance - Youth

  Attendance will be indexed by project staff through chart review, using a standard checklist to tally: team meetings, service encounters, therapy events, no shows and cancellations. For each attended event, 1 point will be assigned. For each, cancellation or no show, 1 point will be deducted. The range of scores will be based on participant behavior and higher scores indicating more robust program participation.

  4-month

• Short Message Service (SMS) Open Rate (SMARTWrap open rate) - Youth

  Short Message Service (SMS) open rate will be calculated from the 16 SMS's that are delivered. Rates will be computed as percentage opened (0-100%) and higher rates indicated more consistent system usage.

  ongoing, over a 4-month period

• Item Completion Rate (SMARTWrap item completion rate) - Youth

  Item completion rate will be calculated from the 48 items that are delivered. Rates will be computed as percentages (0-100%) and higher rates indicated more consistent item completion.

  ongoing, over a 4-month period

• Time to Complete (SMARTWrap time) - Youth

  Time to complete the 16 Short Message Service (SMS) delivered item surveys will be calculated, and reported as a mean in seconds ranging from 0 to 600, with higher scores showing longer completion times.

  ongoing, over a 4-month period

• System Logins (SMARTWrap login) - Care Team

  The number of care team logins will be summed across the implementation period. The scores will range from 0 to an undefined number (based on user behavior) and higher values indicating more system use.

  ongoing, over a 4-month period

• SMART-Wrap User Survey - Care Team

  The SMART-Wrap User Survey-Care Team version is a 20-item study team developed survey to evaluate "real world" user perceptions of SMART-Wrap. Items will focus on the user experience around the Care Team dashboard/features. The items will be scored using a 5-pt Likert scale (1- Strongly disagree to 5- Strongly Agree). Items will be summed and a mean computed (range 1 to 5) and higher scores indicating higher usability.

  4-month

• SMART-Wrap System Usability Scale - Care Team

  The System Usability Scale (SUS) is a widely used 10-item measure of usability considered highly sensitive and robust. Items will be completed using a 5-pt Likert scale (0- Strongly disagree to 4- Strongly Agree). The sum of the scores is multiplied by 2.5 to derive the final score. Scores range from 0-100: \<50 indicates unacceptable usability, 50-70 marginal, and \>70 indicating acceptable.

  4-month

• Current Assessment Practice Evaluation-Revised (CAPER) - Care Team

  Care teams will complete the Current Assessment Practice Evaluation-Revised (CAPER), a 7-item monthly survey asking about target measurement-based care (MBC) behaviors used in their delivery of care, e.g., reviewed data (with a family or supervisor), presented data or information in a meeting, referred to an evidence-based practice. Ratings will be completed using a 4-pt Likert scale (1= None (0%), 2= Some (1-39%), 3= Half 40-60%), and 4= Most (61-100%). Scores will be summed and a mean computed (range 1 to 4) and higher scores indicating greater report of measurement-based care.

  Baseline, 1-month, 2-month, 3-month, 4-month

• Working Alliance Inventory- Short Revised (WAI-SR) - Care Team

  The Working Alliance Inventory (WAI) is a widely used rating scale designed to measure the working alliance between counselors and clients. Both versions have 12 5-point Likert items covering three domains: bond, goals, and tasks. As done in previous studies by the investigators, the WAI will be revised to reflect alliance between the Care Team and family. Scores range from 12 to 60, with higher scores indicating better alliance.

  4-month

• Wraparound Fidelity Index Brief Version WFI-EZ - Care Team

  The Wraparound Fidelity Index Brief Version (WFI-EZ) is a widely used 25-item self-report measure using a 5-pt Likert scale (0-strongly disagree to 4-strongly agree) that assesses fidelity to the Wraparound process. Research shows the WFI-EZ is reliable, valid, and discriminates against groups with differing support to WSM implementation. Scores range from 0 to 100, with higher scores indicating better satisfaction.

  4-month

• Therapist Satisfaction Inventory (TSI) - Care Team

  The Therapist Satisfaction Inventory (TSI) is a 16-item self-report measure using a 5-pt Likert scale (1- Strongly disagree to 5- Strongly agree) that encompasses therapists' affinity for the intervention being used, perceived effectiveness, capacity for individualization and flexibility, and applicability to youths they work with. Ratings are summed and a mean is computed (range 1 to 5) with higher scores indicating greater therapist satisfaction.

  4-month

• Supervision Process Questionnaire (SPQ) - Care Team

  The Supervision Process Questionnaire (SPQ) measures care team ratings of supervision time spent in 8 areas: crisis assessment, administrative tasks, case management issues, case conceptualization, interventions, client relationship, supervisory relationship, and reviewing data on progress. The ratings are made on a 3pt Likert scale (1- Too little, 2- About right, and 3- Too much). Scores are summed across the 8 areas, and an average is computed (range 1 to 3). Overall scores 2 and above indicate adequate supervision.

  Baseline, 4-month

• Attitudes toward Standardized Assessment Scale (ASA) - Care Team

  The Attitudes toward Standardized Assessment Scale (ASA) is a 22-item measure of practitioner perceptions and attitudes about using standardized assessments in their clinical practice. Items are scored on a 1 (Strongly Disagree) to 5 (Strongly Agree) scale , and summed to create a total score (range 22 to 110). Higher rating ratings have been associated with a greater likelihood of standardized assessment use.

  4-month

Study Arms (2)

SMART wrap

EXPERIMENTAL

In the treatment of youth with SED, integrated, multi-model treatment as well as the Wraparound service model (WSM) have been cited as effective community treatments. WSM, like other evidence-based practices, relies on consistently measured data to not only inform care, but also ensure positive outcomes of care. However, research on WSM suggests that the measurement and use of data from participants is inconsistent at best. This intervention, SMS-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. This will provide more consistently gathered data to inform care, improving therapeutic outcomes for participants with SED.

Behavioral: SMARTwrap

Service-As-Usual (SAU)

NO INTERVENTION

Participants assigned to the Services-As-Usual Arm (SAU) will receive Wraparound care as set forth in their clinical organization only. They will not receive the SMS messages that the experimental group is receiving.

Interventions

SMARTwrap BEHAVIORAL

An SMS-based intervention to facilitate regular, repeated evaluation of intermediate outcomes through self-report assessments for youth under Wraparound service model (WSM) care.

SMART wrap

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• be youth with SED aged 8-17 or caregivers of youth with SED age 8-17
• have access to a mobile device

You may not qualify if:

• To reduce heterogeneity and increase interpretability however, youth (approximately 10%) in foster care served by Wraparound provider organizations will be excluded.
• must agree to use SMART-Wrap over an 8-month period to participate
• must include supervisors and care coordinators

Sponsors & Collaborators

• 3-C Institute for Social Development: lead
• University of Washington: collaborator
• National Institute of Mental Health (NIMH): collaborator

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

Central Study Contacts

Melissa DeRosier, PhD

CONTACT

984-316-0406; derosier@3cisd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Investigators will draw a sample of 24 care teams from across three large WPOs (see letters of support). Each care team will have one CC serving at least 5 families initiating WSM during the 4-month study enrollment period. SMART-Wrap (n=12) and SAU (n=12) care teams will be randomly selected from this pool, stratifying by supervisor to balance clustering effects. Each WPO supervisor will have equal numbers of CCs assigned to each condition (approx. 2 CCs for each supervisor), yielding 6 supervisors in each condition. Investigators will only seek to recruit, consent, and enroll n=5 caregivers per CC who will be the primary focus of data collection. This will yield a total recruited sample of N=120 (n=60 per group) caregivers of youth with SED. Eligible participants may be English or Spanish speaking and a caregiver/guardian of a youth aged 8-17 with SED \[defined as at least one MH diagnosis and long-term (\>6 mos) impairment in home, school and/or community functioning.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: December 24, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)