- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01178554
The Clinic Treatment Project (CTP)
March 15, 2011 updated by: Judge Baker Children's Center
Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project - Phase II
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
203
Phase
- 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
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Hawaii
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Honolulu, Hawaii, United States, 96822-2294
- The University of Hawaii at Manoa
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Massachusetts
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Boston, Massachusetts, United States, 02120
- Judge Baker Children's Center
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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
Ages Eligible for Study
7 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Care Treatment
Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.
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Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.
Other Names:
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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).
|
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:
|
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.
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Therapists used the Modular Approach to Therapy for Children with Anxiety, Depression, or Conduct Problems (MATCH-ADC; Chorpita & Weisz, 2004)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Problem Checklist (BPC, parent and child forms)
Time Frame: Change over time from Day 1 to Day 267
|
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.
|
Change over time from Day 1 to Day 267
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.)
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Change over time from Day 1 to Day 267
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Top Problems Assessment
Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up)
|
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.)
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Change over time from Day 1 to Day 712 (24-mo follow-up)
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Youth Self-Report Form (YSR)
Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up)
|
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.)
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Change over time from Day 1 to Day 712 (24-mo follow-up)
|
Child Behavior Checklist (CBCL)
Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up)
|
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.)
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Change over time from Day 1 to Day 712 (24-mo follow-up)
|
Therapeutic Alliance Scale for Children
Time Frame: post-treatment (Day 267)
|
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.)
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post-treatment (Day 267)
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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)
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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.)
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Change over time from Day 1 to Day 712 (24-mo follow-up)
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Revised Children's Anxiety and Depression Scale
Time Frame: Change over time from Day 1 to Day 267
|
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.)
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Change over time from Day 1 to Day 267
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Brief Symptom Inventory
Time Frame: Change over time from Day 1 to Day 267
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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.)
|
Change over time from Day 1 to Day 267
|
Brief Impairment Scale
Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up)
|
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.)
|
Change over time from Day 1 to Day 712 (24-mo follow-up)
|
Services for Children & Adolescents - Parent Interview (SCAPI)
Time Frame: Change over time from Day 1 to Day 712 (24-mo follow-up)
|
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.)
|
Change over time from Day 1 to Day 712 (24-mo follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John R. Weisz, Ph.D., Judge Baker Children's Center
- Principal Investigator: Bruce F. Chorpita, Ph.D., University of Hawaii
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
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
June 1, 2005
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
July 12, 2010
First Submitted That Met QC Criteria
August 9, 2010
First Posted (Estimate)
August 10, 2010
Study Record Updates
Last Update Posted (Estimate)
March 16, 2011
Last Update Submitted That Met QC Criteria
March 15, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 83423-0
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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