The Clinic Treatment Project (CTP)

This study has been completed.
Sponsor:
Collaborators:
John D. and Catherine T. MacArthur Foundation
University of Hawaii
University of Illinois at Chicago
Information provided by:
Judge Baker Children's Center
ClinicalTrials.gov Identifier:
NCT01178554
First received: July 12, 2010
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Anxiety
Depression
Problem Behavior
Behavioral: psychotherapy
Behavioral: evidence-based treatment
Behavioral: modular evidence-based treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project - Phase II

Resource links provided by NLM:


Further study details as provided by Judge Baker Children's Center:

Primary Outcome Measures:
  • Brief Problem Checklist (BPC, parent and child forms) [ Time Frame: Change over time from Day 1 to Day 267 ] [ Designated as safety issue: No ]
    Youth and parents were contacted weekly to report changes in youth functioning. Each person was asked to rate their own or their child's behavior on 12 items (6 internalizing and 6 externalizing behaviors) that were adapted from the Youth Self Report and the Child Behavior Checklist. Children and caregivers completed the pre-treatment assessment on Day 1, every week during treatment, and at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment.


Secondary Outcome Measures:
  • The Children's Interview for Psychiatric Syndromes-Child and Parent Forms (ChIPS/P-ChIPS) [ Time Frame: Change over time from Day 1 to Day 267 ] [ Designated as safety issue: Yes ]
    The ChIPS/P-ChIPS are structured psychiatric interviews designed to assess psychopathology according to DSM-IV criteria in children and adolescents ages 6-18 years. ChIPS/P-ChIPS assess twenty behavioral, anxiety, mood, and other syndromes as well as psychosocial stressors the child might have experienced. Symptoms are assessed using a "yes/no" question format. Onset, offset and duration data are gathered for each disorder. On average, youth and caregivers completed the post-treatment assessment 267 days (SD=124 days) after the pre-treatment assessment.(Used as a measure of clinical outcome.)

  • Top Problems Assessment [ Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up) ] [ Designated as safety issue: No ]
    Youths and parents were asked to identify "The three most important problems for which you need [or "your child needs"] help." at the intake assessment. The six resulting problems (3 from youth, 3 from parent) were then rated on a scale of 0 ("Not serious at all") to 10 ("Very serious problem") by youth and parent. Youths and parents completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment, and at 3-, 6-, 9-, 12- and 24-month follow-up from Day 1. (Used as a measure of clinical outcome.)

  • Youth Self-Report Form (YSR) [ Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up) ] [ Designated as safety issue: Yes ]
    The YSR assesses problems in children on eight narrow-band scales (Withdrawn, Somatic Complaints, Anxious, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, Aggressive Behavior), three broad-band scales (Internalizing, Externalizing, and Total problems), and six DSM-oriented scales. Children completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment, and at 3-, 6-, 9-, 12- and 24-month follow-up from Day 1.(Used as a measure of clinical outcome.)

  • Child Behavior Checklist (CBCL) [ Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up) ] [ Designated as safety issue: Yes ]
    The CBCL assesses problems in children on eight narrow-band scales (Withdrawn, Somatic Complaints, Anxious, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, Aggression), three broad-band scales (Internalizing, Externalizing, and Total problems), and six DSM-oriented scales. Caregivers completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment, and at 3-, 6-, 9-, 12- and 24-month follow-up from Day 1. (Used as a measure of clinical outcome.)

  • Therapeutic Alliance Scale for Children [ Time Frame: post-treatment (Day 267) ] [ Designated as safety issue: No ]
    The quality of youths' working alliance with their therapists was assessed via the Therapeutic Alliance Scale for Children (TASC, Shirk & Saiz, 1992). The 7-item scale comes in both a youth-report form and a parent-report form (parents reporting on their youth's relationship with the therapist). On average, children and caregivers completed the post-treatment assessment 267 days (SD = 124 days) after the pre-treatment assessment. (Available for supplemental analyses.)

  • Service Assessment for Children and Adolescents: Treatment and Auxiliary Service Use Scales [ Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up) ] [ Designated as safety issue: No ]
    The SACA (Horwitz et al., 2001)is a standardized interview for youths and parents that measures use of mental health services across a broad spectrum (including outpatient, inpatient, and school-based). SACA reliability and validity data are well-documented. Caregivers completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment, and at 12- and 24-month follow-up from Day 1.(Available for supplemental analyses.)

  • Revised Children's Anxiety and Depression Scale [ Time Frame: Change over time from Day 1 to Day 267 ] [ Designated as safety issue: Yes ]
    The RCADS is a 47-item child self-report measure that assesses symptoms of several DSM-IV anxiety and depressive disorders (i.e., separation anxiety disorder, social phobia, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, and major depressive disorder). On average, children and caregivers completed the post-treatment assessment 267 days (SD = 124 days) after the pre-treatment assessment.(Available for supplemental analyses.)

  • Brief Symptom Inventory [ Time Frame: Change over time from Day 1 to Day 267 ] [ Designated as safety issue: No ]
    The Brief Symptom Inventory (BSI) is a parent self-report form that is the short form of the Symptom Checklist-90 Revised instrument. The BSI provides a screen for psychological problems. This inventory reports profiles of nine primary symptom dimensions and three global indices of distress (Derogatis, 1993). It can also be used to measuring patient progress during treatment or in the assessment of treatment outcomes. On average, caregivers completed the post-treatment assessment 267 days (SD = 124 days) after the pre-treatment assessment. (Available for supplemental analyses.)

  • Brief Impairment Scale [ Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up) ] [ Designated as safety issue: No ]
    The BIS is a 23-item instrument that evaluates three domains of functioning: interpersonal relations, school/work functioning, and self-care/self-fulfillment. Its advantages over other global impairment instruments are that it is respondent based, short in administration time, and multidimensional. Caregivers completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment, and at 12- and 24-month follow-up from Day 1.(Available for supplemental analyses.)

  • Services for Children & Adolescents - Parent Interview (SCAPI) [ Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up) ] [ Designated as safety issue: No ]
    The SCAPI is a measure that tracks child's use of medication as reported by the parent. Caregivers completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment, and at 3-, 6-, 9-, 12- and 24-month follow-up from Day 1.(Available for supplemental analyses.)


Enrollment: 203
Study Start Date: June 2005
Study Completion Date: June 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care Treatment
Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.
Behavioral: psychotherapy
Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.
Other Names:
  • Treatment As Usual (TAU)
  • Case Management
Experimental: Standard Manual Treatment (SMT)
Evidence-based treatment manuals were used for anxiety (Coping Cat Manual; Kendall, 1994; Kendall et al., 1994 ), depression (Primary and Secondary Control Enhancement Training; Weisz et al., 1997, 1998), and conduct problems (Defiant Children Manual; Barkley, 1997).
Behavioral: evidence-based treatment
Evidence-based treatment manuals were used for anxiety (Coping Cat Manual; Kendall, 1994; Kendall et al., 1994 ), depression (Primary and Secondary Control Enhancement Training; Weisz et al., 1997, 1998), and conduct problems (Defiant Children Manual; Barkley, 1997).
Other Names:
  • best practices
  • evidence-based practices
  • treatment manuals
Experimental: Modular Maual Treatment (MMT)
Therapists used a modular manual (Modular Approach to Therapy for Children with Anxiety, Depression, or Conduct Problems; Chorpita & Weisz, 2004) to help children with primary problems of anxiety, depression, and conduct.
Behavioral: modular evidence-based treatment
Therapists used the Modular Approach to Therapy for Children with Anxiety, Depression, or Conduct Problems (MATCH-ADC; Chorpita & Weisz, 2004)
Other Names:
  • modular treatments
  • best practices
  • evidence-based practices

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

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178554

Locations
United States, Hawaii
The University of Hawaii at Manoa
Honolulu, Hawaii, United States, 96822-2294
United States, Massachusetts
Judge Baker Children's Center
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Judge Baker Children's Center
John D. and Catherine T. MacArthur Foundation
University of Hawaii
University of Illinois at Chicago
Investigators
Principal Investigator: John R. Weisz, Ph.D. Judge Baker Children's Center
Principal Investigator: Bruce F. Chorpita, Ph.D. University of Hawaii
  More Information

Additional Information:
Publications:
Chorpita BF, Reise SP, Weisz JR, Grubbs K, Becker KD, Krull J. Evaluation of the Brief Problem Checklist: Child and caregiver Interviews to measure clinical progress. Journal of Consulting and Clinical Psychology. In press.
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.
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.
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John R. Weisz, Judge Baker Children's Center
ClinicalTrials.gov Identifier: NCT01178554     History of Changes
Other Study ID Numbers: 83423-0
Study First Received: July 12, 2010
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Judge Baker Children's Center:
anxiety disorders
depression
depressive disorders
disruptive behavioral problems
conduct problems

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 22, 2014