Mental Health Wellness 1NCT01308879
Effects of Routine Feedback to Clinicians on Youth Mental Health Outcomes: A Randomized Cluster Design
A study testing Contextualized Feedback Systems (CFS)tm in people with Mental Health Wellness 1 and Psychosocial Problem, run by Vanderbilt University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Mental Health Wellness 1, Psychosocial Problem
- What is being tested?
- Contextualized Feedback Systems (CFS)tm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Jun 2009
- Phase
- Interventional
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all youths 11-18 years old, entering treatment as usual, home-based services through the service provider. Youths' primary caregiver and clinician also participate.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
28 sites in 10 states affiliated with Providence Service Corporation (location info is for corporate office)
Tucson, Arizona, 85701
About this study
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.
Read the 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.
- Conditions
- Mental Health Wellness 1, Psychosocial Problem
- Being tested
- Contextualized Feedback Systems (CFS)tm
- Keywords
- Contextualized Feedback System (CFS), Mental health outcomes, Quality improvement, Feedback, Clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contextualized Feedback Systems (CFS)tmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Weekly feedback | Experimental | 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. Receives: Behavioral: Contextualized Feedback Systems (CFS)tm |
| No feedback | Other | 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. Receives: Behavioral: Contextualized Feedback Systems (CFS)tm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and Functioning Severity Scale
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).
Measured: 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 outcomes (2)
Brief Multidimensional Students' Life Satisfaction Scale-CEPI (BMSLSS-CEPI)
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).
Measured: 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)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMay 2004
- Primary completionDec 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Leon Lowenstein Foundation Inc.
- Investigators
- Leonard Bickman, Ph.D., Principal investigator, Center for Evaluation and Program Improvement, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308879
- Sponsor's protocol ID
- 070342
- Other IDs
- R01MH068589
- Status last verified
- Mar 2011
- First submitted
- 2 Mar 2011
- Last updated
- 4 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Routine Feedback to Clinicians on Youth Mental Health Outcomes: A Randomized Cluster Design
- ClinicalTrials.gov ID
- NCT01308879
- Acronym / sponsor ID
- 070342
- Conditions
- Mental Health Wellness 1, Psychosocial Problem
- Keywords
- Contextualized Feedback System (CFS), Mental health outcomes, Quality improvement, Feedback, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Leon Lowenstein Foundation Inc.
- Study start
- May 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Mar 2011 (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 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly feedback | Experimental | Behavioral: Contextualized Feedback Systems (CFS)tmAfter 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. |
| No feedback | Other | Behavioral: Contextualized Feedback Systems (CFS)tmClinicians 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. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all youths 11-18 years old, entering treatment as usual, home-based services through the service provider. Youths' primary caregiver and clinician also participate.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Contextualized Feedback Systems (CFS)tmAfter 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. | Behavioural | No feedback, Weekly feedback |
Primary outcome
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).
2 secondary outcomes
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 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
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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.
Leonard Bickman, Ph.D. principal investigator
Center for Evaluation and Program Improvement, Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contextualized Feedback Systems (CFS)tm in people with Mental Health Wellness 1 and Psychosocial Problem, run by Vanderbilt University 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 0 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: finished, as of the sponsor's last update on 4 Mar 2011. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2011.