Clinical trial NCT01178554: The Clinic Treatment Project
Official title: Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project - Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Problem Behavior
Keywords: anxiety disorders
depression
depressive disorders
disruptive behavioral problems
conduct problems
Lead sponsor: Judge Baker Children's Center
Sponsor class: OTHER
Collaborators: name: MacArthur Foundation
name: University of Hawaii
name: University of Illinois at Chicago
First posted: 2010-08-10
Enrollment: 203
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Clinic Treatment Project tested two alternative methods of delivering evidence-based practices within public community-based mental health clinics, using training and supervision procedures designed for the settings and users.

Detailed description: The Clinic Treatment Project focused on ethnically diverse youths aged 7-13 who were referred to community-based mental health clinics for problems involving disruptive behaviors, depression, anxiety, and any combination of these. Using a randomized block design, therapists were randomly assigned to deliver usual treatment procedures (usual care, or UC) in their clinics or evidence-based practices deployed in two forms: (a) standard manual treatment (SMT), using full treatment manuals, one at a time, exactly as they have been tested in clinical trials, and (b) modular manual treatment (MMT) in which therapists learn the component practices of the standard manuals but individualize the use of the components for each child using a guiding clinical algorithm. Unlike the SMT approach, the MMT approach allows the duration and sequencing of techniques to be individualized in an effort to fit the child's needs and allows the clinician to draw techniques from outside the target disorder domain when needed (e.g., to address noncompliance during the course of treating depression). Both SMT and MMT were supported by training and supervision procedures designed to fit providers and their clinic contexts. Assessments were carried out at pre-treatment, at post-treatment, and at 3-, 6-, 9-, 12-, 18-, and 24-month follow-ups. Assessments carried out at pre-treatment included(a) individual youth problems and disorders; (b) individual youth functioning at home and school; and (c) clinic staff beliefs and attitudes toward their work and workplace. Assessments carried out at post-treatment and follow-up only included measures of (a) youth, parent, and therapist satisfaction with treatment; (b) youth, parent and therapist views on the quality of the therapeutic relationship; and (c) treatment costs. Assessments carried out at follow-up only included (a) parent reports of any mental health service use following project treatment, and (b) therapist reports on the extent to which the treatment procedures they used in the project are continued after project termination. Analyses will address critical questions about deployment of evidence-based youth practices to clinical care settings.

Eligibility criteria: Inclusion Criteria:

* 7 - 13 year olds and their parents
* seeking services at community mental health clinics
* primary problem or disorder related to anxiety, depression, or conduct problems

Exclusion Criteria:

* Child is younger than 7 years, 9 months or older than 13 on the day of the phone screen.
* Child has attempted suicide within the past year.
* Schizophrenic spectrum diagnosis (including MDD w/ psychotic features)
* Autism or another Pervasive Developmental Disorder (e.g., PDD NOS, Asperger's Disorder, Child Disintegrative Disorder, Rett's Disorder).
* Anorexia Nervosa
* Bulimia Nervosa
* Mental Retardation
* No relevant T-scores validate target disorders.
* ADHD identified as primary reason for seeking treatment at phone screen
* Child's sibling already included
* Child's medication has not been regulated for one month or longer

Primary outcomes:
measure: Brief Problem Checklist (BPC, parent and child forms)
timeFrame: Change over time from Day 1 to Day 267
Secondary outcomes:
measure: The Children's Interview for Psychiatric Syndromes-Child and Parent Forms (ChIPS/P-ChIPS)
timeFrame: Change over time from Day 1 to Day 267
measure: Top Problems Assessment
timeFrame: Change over time from Day 1 to Day 712 (24-mo follow-up)
measure: Youth Self-Report Form (YSR)
timeFrame: Change over time from Day 1 to Day 712 (24-mo follow-up)
measure: Child Behavior Checklist (CBCL)
timeFrame: Change over time from Day 1 to Day 712 (24-mo follow-up)
measure: Therapeutic Alliance Scale for Children
timeFrame: post-treatment (Day 267)
measure: Service Assessment for Children and Adolescents: Treatment and Auxiliary Service Use Scales
timeFrame: Change over time from Day 1 to Day 712 (24-mo follow-up)
measure: Revised Children's Anxiety and Depression Scale
timeFrame: Change over time from Day 1 to Day 267
measure: Brief Symptom Inventory
timeFrame: Change over time from Day 1 to Day 267
measure: Brief Impairment Scale
timeFrame: Change over time from Day 1 to Day 712 (24-mo follow-up)
measure: Services for Children & Adolescents - Parent Interview (SCAPI)
timeFrame: Change over time from Day 1 to Day 712 (24-mo follow-up)
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: The University of Hawaii at Manoa
state: Hawaii
city: Boston
country: United States
facility: Judge Baker Children's Center
state: Massachusetts
Study officials:
affiliation: Judge Baker Children's Center
name: John R. Weisz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hawaii
name: Bruce F. Chorpita, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chorpita BF, Bernstein A, Daleiden EL; Research Network on Youth Mental Health. Driving with roadmaps and dashboards: using information resources to structure the decision models in service organizations. Adm Policy Ment Health. 2008 Mar;35(1-2):114-23. doi: 10.1007/s10488-007-0151-x. Epub 2007 Nov 6.
citation: Borntrager CF, Chorpita BF, Higa-McMillan C, Weisz JR. Provider attitudes toward evidence-based practices: are the concerns with the evidence or with the manuals? Psychiatr Serv. 2009 May;60(5):677-81. doi: 10.1176/ps.2009.60.5.677.
citation: Ebesutani C, Bernstein A, Nakamura BJ, Chorpita BF, Higa-McMillan CK, Weisz JR; The Research Network on Youth Mental Health. Concurrent Validity of the Child Behavior Checklist DSM-Oriented Scales: Correspondence with DSM Diagnoses and Comparison to Syndrome Scales. J Psychopathol Behav Assess. 2010 Sep;32(3):373-384. doi: 10.1007/s10862-009-9174-9. Epub 2009 Nov 27.
citation: Chorpita BF, Reise S, Weisz JR, Grubbs K, Becker KD, Krull JL; Research Network on Youth Mental Health. Evaluation of the Brief Problem Checklist: child and caregiver interviews to measure clinical progress. J Consult Clin Psychol. 2010 Aug;78(4):526-36. doi: 10.1037/a0019602.
citation: Ebesutani C, Bernstein A, Nakamura BJ, Chorpita BF, Weisz JR; Research Network on Youth Mental Health. A psychometric analysis of the revised child anxiety and depression scale--parent version in a clinical sample. J Abnorm Child Psychol. 2010 Feb;38(2):249-60. doi: 10.1007/s10802-009-9363-8.
citation: Ho A, Weisz JR, Austin AA, Chorpita BF, Southam-Gerow M, Wells K, the Research Network on Youth Mental Health. Bridging science and community practice: Clinician and organizational engagement in community clinics in the clinic treatment project. Emotional and Behavioral Disorders in Youth. Winter 2006;7:13-19.
citation: Martin JL, Weisz JR, Chorpita BF, Higa CK, Southam-Gerow M, Wells K, the Research Network on Youth Mental Health. Moving evidence-based practices into everyday clinical care settings: Addressing challenges associated with pathways to treatment, child characteristics, and structure of treatment. Emotional and Behavioral Disorders in Youth. Winter 2006;7:5-21.
citation: Palinkas LA, Aarons GA, Chorpita BF, Hoagwood K, Landsverk J, Weisz JR; Research Network on Youth Mental Health. Cultural exchange and the implementation of evidence-based practice: two case studies. J Evidence-Based Social Work. 2009 September;19(5):602-612.
citation: Palinkas LA, Schoenwald SK, Hoagwood K, Landsverk J, Chorpita BF, Weisz JR; Research Network on Youth Mental Health. An ethnographic study of implementation of evidence-based treatments in child mental health: first steps. Psychiatr Serv. 2008 Jul;59(7):738-46. doi: 10.1176/ps.2008.59.7.738.
citation: Weisz JR, Chorpita BF, Palinkas LA, Schoenwald SK, Miranda J, Bearman SK, Daleiden EL, Ugueto AM, Ho A, Martin J, Gray J, Alleyne A, Langer DA, Southam-Gerow MA, Gibbons RD; Research Network on Youth Mental Health. Testing standard and modular designs for psychotherapy treating depression, anxiety, and conduct problems in youth: a randomized effectiveness trial. Arch Gen Psychiatry. 2012 Mar;69(3):274-82. doi: 10.1001/archgenpsychiatry.2011.147. Epub 2011 Nov 7.