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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
356

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85701
        • 28 sites in 10 states affiliated with Providence Service Corporation (location info is for corporate office)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Contextualized Feedback Systems (CFS)tm
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.
Behavioral: Contextualized Feedback Systems (CFS)tm
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Leon Lowenstein Foundation Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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