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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01308879
Other study ID # 070342
Secondary ID R01MH068589
Status Completed
Phase N/A
First received March 2, 2011
Last updated March 3, 2011
Start date May 2004
Est. completion date June 2009

Study information

Verified date March 2011
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 356
Est. completion date June 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 11 Years to 18 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States 28 sites in 10 states affiliated with Providence Service Corporation (location info is for corporate office) Tucson Arizona

Sponsors (3)

Lead Sponsor Collaborator
Vanderbilt University Leon Lowenstein Foundation Inc., National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 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). No
Secondary 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). 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). No
Secondary 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. 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). No
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