- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01308879
Effects of Routine Feedback to Clinicians on Youth Mental Health Outcomes: A Randomized Cluster Design
March 3, 2011 updated by: Vanderbilt University
The purpose of this clinical trial was to test the hypothesis that clients of clinicians who were scheduled to receive weekly feedback on their clients' progress would improve faster than clients of clinicians who were not scheduled to receive weekly feedback.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary approach to improving psychosocial treatment for youths has been to implement evidence-supported treatments (ESTs) in community services.
However, this approach has not produced clear cut results of effectiveness.
A recently developed alternative is to improve outcomes through routine measurement and feedback to clinicians and supervisors.
The investigators used a cluster randomized experiment with 28 sites affiliated with a national behavioral health organization to assess whether clients of clinicians who were scheduled to receive weekly feedback on their clients' progress would improve faster than clients of clinicians who were not scheduled to receive weekly feedback.
Study Type
Interventional
Enrollment (Actual)
356
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85701
- 28 sites in 10 states affiliated with Providence Service Corporation (location info is for corporate office)
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all youths 11-18 years old, entering treatment as usual, home-based services through the service provider. Youths' primary caregiver and clinician also participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Weekly feedback
After clinical questionnaires are entered into the system (CFStm), an automated online report is available weekly to clinicians in the experimental group that shows current mental health status of youths, alerts, and trends over time based on youth, caregiver, and clinician responses.
Reports also show some clinical data on caregivers.
|
After clinical questionnaires are entered, an automated feedback report is available online weekly to clinicians (and supervisors) in the experimental group.
The report shows current mental health status of youths, alerts, and trends over time.
Reports also show some clinical data on youths' caregivers.
|
Other: No feedback
Clinicians in the control group do not have access to weekly feedback.
Instead, they receive reports every 90 days after the youth is enrolled in CFStm.
Because the average duration of CFS enrollment was 3.8 months, many youths would have been discharged before the first 90-day report became available three months after treatment start.
Thus, we considered the 90-day feedback group to be essentially a no-feedback group.
|
After clinical questionnaires are entered, an automated feedback report is available online weekly to clinicians (and supervisors) in the experimental group.
The report shows current mental health status of youths, alerts, and trends over time.
Reports also show some clinical data on youths' caregivers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms and Functioning Severity Scale
Time Frame: The SFSS is completed at intake by youths and caregivers, then by youths, caregivers, and clinicians at the 1st treatment session and every other session (week) thereafter for as long as the youth is enrolled in the intervention (CFS).
|
The SFSS is part of a battery of clinical measures (Peabody Treatment Progress Battery:PTPB) developed by the researchers.
It assesses change in closely-timed repeated measurements.
Parallel forms are completed by youths, caregivers, and clinicians at the end of treatment sessions.
The SFSS includes 32 items that ask the respondent to rate how frequently in the last two weeks the youth experienced emotions or exhibited behaviors linked to typical mental health disorders for youths (e.g., ADHD, conduct disorder, depression).
|
The SFSS is completed at intake by youths and caregivers, then by youths, caregivers, and clinicians at the 1st treatment session and every other session (week) thereafter for as long as the youth is enrolled in the intervention (CFS).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Multidimensional Students' Life Satisfaction Scale-CEPI (BMSLSS-CEPI)
Time Frame: The BMSLSS-CEPI is completed by the youth at intake, at the 2nd treatment session, and every 8 weeks thereafter for as long as the youth is enrolled in the intervention (CFS).
|
The BMSLSS-CEPI is a revised version of the Brief Multidimensional Students' Life Satisfaction Scale (Seligson, Huebner, & Valois, 2003).
The BMSLSS-CEPI was designed to assess global life satisfaction as well as domain specific satisfaction with family, friends, school, self and living environment.
Life satisfaction may be targeted directly or indirectly with treatment and thus can be thought of as a positive, or strengths-based, indicator of treatment progress (outcome).
|
The BMSLSS-CEPI is completed by the youth at intake, at the 2nd treatment session, and every 8 weeks thereafter for as long as the youth is enrolled in the intervention (CFS).
|
The Children's Hope Scale (CHS)
Time Frame: The CHS is completed by the youth at intake and every 8 weeks thereafter for as long as the youth is enrolled in the intervention (CFS).
|
The CHS (Snyder et al., 1997), a public domain measure used with youth in this study, assesses youth hopefulness.
The measure asks youths to report on their ability to generate paths toward goals and persevere toward those goals.
Youth hopefulness is conceptually an important factor in the successful treatment of emotional or behavioral disorders, constituting an outcome that may be affected by the treatment process.
|
The CHS is completed by the youth at intake and every 8 weeks thereafter for as long as the youth is enrolled in the intervention (CFS).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leonard Bickman, Ph.D., Center for Evaluation and Program Improvement, Vanderbilt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
March 2, 2011
First Submitted That Met QC Criteria
March 3, 2011
First Posted (Estimate)
March 4, 2011
Study Record Updates
Last Update Posted (Estimate)
March 4, 2011
Last Update Submitted That Met QC Criteria
March 3, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 070342
- R01MH068589 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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