Overall Functioning Clinical Trial
— STEPSOfficial title:
Improving Practice in Community-based Settings: A Randomized Trial of Supervision Strategies
The primary goal of this study is to examine the impact of varying supervision strategies on
clinician fidelity and client outcomes in a community-based setting. Prior research has
established that training approaches that do not include a period of intervention-specific
supervision or consultation are ineffective and that implementation efforts that include
only an initial period of supervision show an eventual attenuation of gains in knowledge and
fidelity in practice. Ongoing supervision may be required for effective and sustained
implementation of evidence-based practices (EBPs) in community-based settings. However,
supervision is one of the least investigated aspects of training. "Gold standard" elements
of supervision from efficacy trials include review of sessions, standardized procedures for
monitoring client outcomes and model fidelity, and ongoing skill-building (e.g., behavioral
rehearsal). The degree (e.g., frequency, intensity) to which these strategies are used in
community-based settings is unknown.
There are a growing number of national and statewide efforts to increase the reach of EBPs
through dissemination and implementation initiatives. There are 18 statewide initiatives to
implement Trauma-focused Cognitive Behavioral Therapy (TF-CBT), an EBP for child trauma
exposure and sequelae. Many of the community based TF-CBT implementation efforts, and those
for other EBPs, include a specific focus on supervisors. However, the limited scientific
literature provides very little guidance for these efforts. Aims of the current trial
include 1) studying supervision with existing implementation supports; particularly presence
of gold standard elements; 2) evaluating the effects of varying supervision strategies on
fidelity and client outcomes; and 3) testing the mediating effect of treatment fidelity on
the relationship between supervision type and client outcomes. We propose a two-phased,
within-subjects and between subjects design. In Phase I (9 months), we examined supervision
with implementation support. In Phase II (30 months), we will examine two specific
supervision conditions, each including varying EBP supervision elements.
| Status | Recruiting |
| Enrollment | 1280 |
| Est. completion date | March 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - Children between the ages of 6-17 who are starting Trauma-focused Cognitive Behavioral Therapy (TF-CBT) with one of our enrolled clinicians.They must also have significant Post Traumatic Stress symptoms as measured by a score of 21 or higher on the UCLA PTSD-RI, and live with a parent or guardian who is willing to participate in the study. - Community-based mental health clinicians who are employed in Regional Support Network agencies (state Medicaid clinics) who have participated in the Washington State Initiative for TF-CBT and are supervised by a participating supervisor, or have completed the TF-CBT web training and been supervised on a case. - Community-based mental health supervisors trained in the WA State Initiative in TF-CBT and employed at participating clinics in WA. Exclusion Criteria: - Non-English speaking child. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Washington Department of Psychology | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| University of Washington | National Institute of Mental Health (NIMH), University of Medicine and Dentistry of New Jersey |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Coding Therapy Sessions to Assess Clinician Fidelity to TF-CBT Strategy. | Evidence-Based Practices such as Trauma-focused Cognitive Behavioral Therapy (TF-CBT) usually include ongoing supervision to assess how true (e.g. fidelity) clinicians stay to their training in the specific treatment. We will be coding therapy audio recordings using an adapted TF-CBT Therapy Process Observational Coding System for Children (TF-CBT TPOCS-S) scoring manual. We will also use clinician self-report of fidelity using the Washington State Evidence Based Practice (EBP) Toolkit, and supervisor-report of fidelity in the EBP Toolkit. We will ultimately be assessing how fidelity serves as a mediator for the relationship between supervision condition and client outcomes. |
2 years | No |
| Secondary | Client outcomes for Post-Traumatic Stress and overall functioning | We will complete phone interviews with children and guardians to assess the client outcomes at baseline, 3 months post-baseline, and 6 months post-baseline. We will use the UCLA Post Traumatic Stress Disorder Reaction Index (PTSD RI) to assess trauma exposure and post-traumatic stress symptoms. We will use the Strengths and Difficulties Questionnaire (SDQ), a short behavioral screening survey, to assess overall functioning. | 6 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01499797 -
The CareWell-programme for Community-dwelling Frail Elderly Persons.
|
N/A |