Serious Emotional Disturbance of YouthPhase 1/2NCT02421874
Development and Testing of an Electronic Behavioral Health Record Specific to the Wraparound Care Coordination Process
A Phase 1/2 study testing Wraparound Team Monitoring System electronic health record and Education about fidelity maintenance and monitoring in people with Serious Emotional Disturbance of Youth, run by University of Washington at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Serious Emotional Disturbance of Youth
- What is being tested?
- Wraparound Team Monitoring System electronic health record and Education about fidelity maintenance and monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jan 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Non English speaking parents
- Foster parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Usability Testing, and Effectiveness Evaluation of Wraparound Team Monitoring System
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:
- 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.
- 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.
- Conditions
- Serious Emotional Disturbance of Youth
- Being tested
- Wraparound Team Monitoring System electronic health record, Education about fidelity maintenance and monitoring
- Keywords
- Patient care team, Care management, Electronic health records
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wraparound Team Monitoring System electronic health recordBehavioural
Wraparound Team Monitoring System (Wrap-TMS) is 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
Education about fidelity maintenance and monitoringBehavioural
As an active comparator, we will educate practitioners randomized to the control condition about the importance of maintaining fidelity and monitoring fidelity and progress via a 3 hour training.
| Study group | Role | What they receive |
|---|---|---|
| Use of electronic health record / outcomes monitoring | Experimental | Use of electronic health record / outcomes monitoring via a specified electronic behavioral health information system Receives: Behavioral: Wraparound Team Monitoring System electronic health record |
| education about outcomes monitoring | Active comparator | Care coordination as usual with education about fidelity and outcomes monitoring but no use of EBHIS Receives: Behavioral: Education about fidelity maintenance and monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (2)
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
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Serious Emotional Disturbance of YouthStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Bruns, University of Washington
- Investigators
- Eric J Bruns, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421874
- Sponsor's protocol ID
- 2R42MH095516
- Status last verified
- Oct 2016
- First submitted
- 10 Apr 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bruns EJ, Hook AN, Parker EM, Esposito I, Sather A, Parigoris RM, Lyon AR, Hyde KL. Impact of a Web-Based Electronic Health Record on Behavioral Health Service Delivery for Children and Adolescents: Randomized Controlled Trial. J Med Internet Res. 2018 Jun 14;20(6):e10197. doi: 10.2196/10197.
PubMed 29903701
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Usability Testing, and Effectiveness Evaluation of Wraparound Team Monitoring System
- ClinicalTrials.gov ID
- NCT02421874
- Acronym / sponsor ID
- 2R42MH095516
- Conditions
- Serious Emotional Disturbance of Youth
- Keywords
- Patient care team, Care management, Electronic health records
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of electronic health record / outcomes monitoring | Experimental | Behavioral: Wraparound Team Monitoring System electronic health recordUse of electronic health record / outcomes monitoring via a specified electronic behavioral health information system |
| education about outcomes monitoring | Active comparator | Behavioral: Education about fidelity maintenance and monitoringCare coordination as usual with education about fidelity and outcomes monitoring but no use of EBHIS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- Non English speaking parents
- Foster parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wraparound Team Monitoring System electronic health recordWraparound Team Monitoring System (Wrap-TMS) is 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 | Behavioural | Use of electronic health record / outcomes monitoring |
| Education about fidelity maintenance and monitoringAs an active comparator, we will educate practitioners randomized to the control condition about the importance of maintaining fidelity and monitoring fidelity and progress via a 3 hour training. | Behavioural | education about outcomes monitoring |
Primary outcome
more effective teamwork (Team Climate Inventory (TCI)
Time frame: 6 months
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
treatment alliance (Working Alliance Inventory (WAI)
Time frame: 6 months
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
improved youth functioning (Top Problem Assessment (TPA)
Time frame: 6 months
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.
2 secondary outcomes
parent and provider satisfaction (Parent and Child Satisfaction Scales)
Time frame: 3 months
attitudes toward standardized assessment (Attitudes toward Standardized Assessment Scale (ASA)105)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 29903701Bruns EJ, Hook AN, Parker EM, Esposito I, Sather A, Parigoris RM, Lyon AR, Hyde KL. Impact of a Web-Based Electronic Health Record on Behavioral Health Service Delivery for Children and Adolescents: Randomized Controlled Trial. J Med Internet Res. 2018 Jun 14;20(6):e10197. doi: 10.2196/10197.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Bruns, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Wraparound Team Monitoring System electronic health record and Education about fidelity maintenance and monitoring in people with Serious Emotional Disturbance of Youth, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
more effective teamwork (Team Climate Inventory (TCI) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02421874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.