Serious Emotional Disturbance of Youth Clinical Trial
Official title:
Development, Usability Testing, and Effectiveness Evaluation of Wraparound Team Monitoring System
| Verified date | October 2016 |
| Source | University of Washington |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this Phase II Small Business Technology Transfer (STTR) project is to
complete development and evaluate usability and effectiveness of the Wraparound Team
Monitoring System (Wrap-TMS), a web-based, electronic behavioral health information system
(EBHIS) for the most widely implemented care coordination model in children's behavioral
health, the wraparound process. Though wraparound is now considered "evidence-based,"
implementation in the real world often fails to conform to standards of fidelity and/or use
objective data to guide management, supervision, and clinical decision making. Availability
of such a system will support efficiency, implementation quality and fidelity, and outcomes
for youths enrolled in wraparound. Wrap-TMS features functionality for data entry,
management, and basic reporting for the full array of data and information elements needed
to manage an integrated care coordination initiative for youths with serious emotional and
behavioral disorder (SEBD). In light of our success in Phase I, subsequent partnerships with
federal agencies, and inquiries of interest from several states and over 20 provider and
managed care organizations, in this Phase II STTR the investigators will complete
development of Wrap-TMS, followed by a randomized controlled effectiveness study comparing
n=25 wraparound facilitators who use Wrap-TMS serving n=100 families to 25 non-user
facilitators serving 100 families on practitioner, implementation, and youth/family
outcomes. The evaluation will test two primary hypotheses:
1. Compared to facilitators in the control group, wraparound facilitators trained to use
Wrap-TMS will demonstrate (a) greater use of data and feedback in service delivery; (b)
greater fidelity to the wraparound process; (c) higher self-reported teamwork, working
alliance, and satisfaction with the intervention; and (d) more positive attitudes
toward standardized assessment.
2. Compared to the control group, parents of youths receiving services from facilitators
trained to use TMS will report (a) greater goal clarity, (b) more data collection and
use (c) greater satisfaction with services and progress, (d) better fidelity to
wraparound, (e) more effective team functioning, (f) greater treatment alliance, and
(f) better youth outcomes including greater progress and improved symptoms and
functioning.
| Status | Active, not recruiting |
| Enrollment | 160 |
| Est. completion date | January 2017 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Parent or legal guardian of a youth aged 6-17 with SEBD (serious emotional and behavioral disorder): at least one MH (mental health) diagnosis that results in long-term (>6 mos) impairment in home, school and/or community functioning). Exclusion Criteria: - Non English speaking parents - Foster parents |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Washington | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| University of Washington |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | more effective teamwork (Team Climate Inventory (TCI) | Team Climate Inventory (TCI). The TCI is a 38-item survey that evaluates five relevant aspects of health care teamwork (Shared Vision, Participation safety, Support for Innovation, Task orientation, Interaction frequency) using a 5 point Likert scale. Assessed at 4 mos. post enrollment | 6 months | No |
| Primary | treatment alliance (Working Alliance Inventory (WAI) | Working Alliance Inventory (WAI) is a widely used rating scale designed to measure the working alliance between counselors and clients. Assessed at 4 mos. post enrollment | 6 months | No |
| Primary | improved youth functioning (Top Problem Assessment (TPA) | Top Problem Assessment (TPA) is a consumer-focused index the severity of the top three problems nominated by the parent, on a scale of 0-10. Assessed at BL, 1, 2, 3, 4 mos. | 6 months | No |
| Secondary | parent and provider satisfaction (Parent and Child Satisfaction Scales) | Parent and Child 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, satisfaction with progress, and (5) global satisfaction. Assessed at 4 mos post enrollment | 3 months | No |
| Secondary | attitudes toward standardized assessment (Attitudes toward Standardized Assessment Scale (ASA)105) | Attitudes toward Standardized Assessment Scale (ASA)105. A 22-item measure of clinician 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 yield 3 subscales with adequate or better reliabilities: Benefit over Clinical Judgment, Psychometric Quality, and Practicality. Administered to practitioners at baseline and 4 mos. | 3 months | No |