The Clinic Treatment Project

Study Overview
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Brief Summary
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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
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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.

Official Title
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Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project - Phase II

Conditions
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Anxiety, Depression, Problem Behavior

Intervention / Treatment
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* Behavioral: psychotherapy
* Behavioral: evidence-based treatment
* Behavioral: modular evidence-based treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Treatment<br>Usual Care therapists could use any treatment procedures they used regularly in their clinical practice. | Behavioral: psychotherapy<br>* Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.<br>* Other names: Case Management;|
| Experimental: Standard Manual Treatment (SMT)<br>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<br>* 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).<br>* Other names: treatment manuals;|
| Experimental: Modular Maual Treatment (MMT)<br>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<br>* Therapists used the Modular Approach to Therapy for Children with Anxiety, Depression, or Conduct Problems (MATCH-ADC; Chorpita & Weisz, 2004)<br>* Other names: evidence-based practices;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Problem Checklist (BPC, parent and child forms) | 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) | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety disorders, depression, depressive disorders, disruptive behavioral problems, conduct problems