The Clinic Treatment Project (CTP)
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ClinicalTrials.gov Identifier: NCT01178554 |
Recruitment Status
:
Completed
First Posted
: August 10, 2010
Last Update Posted
: March 16, 2011
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Condition or disease | Intervention/treatment | Phase |
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Anxiety Depression Problem Behavior | Behavioral: psychotherapy Behavioral: evidence-based treatment Behavioral: modular evidence-based treatment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 203 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project - Phase II |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
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Active Comparator: Usual Care Treatment
Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.
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Behavioral: psychotherapy
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).
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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:
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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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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:
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- 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.
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)

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Ages Eligible for Study: | 7 Years to 13 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178554
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 |
Principal Investigator: | John R. Weisz, Ph.D. | Judge Baker Children's Center | |
Principal Investigator: | Bruce F. Chorpita, Ph.D. | University of Hawaii |
Additional Information:
Publications:
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 |
First Posted: | August 10, 2010 Key Record Dates |
Last Update Posted: | March 16, 2011 |
Last Verified: | March 2011 |
Keywords provided by Judge Baker Children's Center:
anxiety disorders depression depressive disorders disruptive behavioral problems conduct problems |
Additional relevant MeSH terms:
Depression Problem Behavior Behavioral Symptoms |