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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
203

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96822-2294
        • The University of Hawaii at Manoa
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Judge Baker Children's Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Case Management
  • Treatment As Usual (TAU)
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:
  • best practices
  • evidence-based practices
  • modular treatments

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.)
Change over time from Day 1 to Day 267
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.)
Change over time from Day 1 to Day 712 (24-mo follow-up)
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.)
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.)
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.)
post-treatment (Day 267)
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)
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.)
Change over time from Day 1 to Day 712 (24-mo follow-up)
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.)
Change over time from Day 1 to Day 267
Brief Symptom Inventory
Time Frame: Change over time from Day 1 to Day 267
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Judge Baker Children's Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Illinois at Chicago
University of Hawaii
MacArthur Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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