AnxietyCTPNCT01178554
The Clinic Treatment Project
A study testing psychotherapy, evidence-based treatment and modular evidence-based treatment in people with Anxiety and Depression, run by Judge Baker Children's Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Anxiety, Depression, Problem Behavior
- What is being tested?
- psychotherapy, evidence-based treatment and modular evidence-based treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2005to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Judge Baker Children's Center
Boston, Massachusetts, 02120
The University of Hawaii at Manoa
Honolulu, Hawaii, 96822-2294
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression, Problem Behavior
- Being tested
- psychotherapy, evidence-based treatment, modular evidence-based treatment
- Keywords
- anxiety disorders, depression, depressive disorders, disruptive behavioral problems, conduct problems
- Medical subject headings
- Anxiety Disorders, Depression, Problem Behavior, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapyBehavioural
Also called Treatment As Usual (TAU), Case Management
Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.
evidence-based treatmentBehavioural
Also called best practices, evidence-based practices, treatment manuals
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).
modular evidence-based treatmentBehavioural
Also called modular treatments, best practices, evidence-based practices
Therapists used the Modular Approach to Therapy for Children with Anxiety, Depression, or Conduct Problems (MATCH-ADC; Chorpita \& Weisz, 2004)
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Treatment | Active comparator | Usual Care therapists could use any treatment procedures they used regularly in their clinical practice. Receives: Behavioral: psychotherapy |
| Standard Manual Treatment (SMT) | Experimental | 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). Receives: Behavioral: evidence-based treatment |
| Modular Maual Treatment (MMT) | Experimental | 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. Receives: Behavioral: modular evidence-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change over time from Day 1 to Day 267
Secondary outcomes (10)
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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: Change over time from Day 1 to Day 712 (24-mo follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startJun 2005
- Primary completionMay 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Judge Baker Children's Center
- Sponsor type
- University, hospital or other
- Collaborators
- MacArthur Foundation, University of Hawaii, University of Illinois at Chicago
- Investigators
- John R. Weisz, Ph.D., Principal investigator, Judge Baker Children's CenterBruce F. Chorpita, Ph.D., Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178554
- Sponsor's protocol ID
- 83423-0
- Acronym
- CTP
- Status last verified
- Mar 2011
- First submitted
- 12 Jul 2010
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17987376Borntrager 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.
PubMed 19411357Ebesutani 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.
PubMed 20700377Chorpita 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.
PubMed 20658809Ebesutani 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.
PubMed 19830545Ho 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.
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.
PubMed 18586990Weisz 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.
PubMed 22065252
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project - Phase II
- ClinicalTrials.gov ID
- NCT01178554
- Acronym / sponsor ID
- CTP / 83423-0
- Conditions
- Anxiety, Depression, Problem Behavior
- Keywords
- anxiety disorders, depression, depressive disorders, disruptive behavioral problems, conduct problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Judge Baker Children's CenterUniversity, hospital or other
- Collaborators
- MacArthur Foundation, University of Hawaii, University of Illinois at Chicago
- Study start
- Jun 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care Treatment | Active comparator | Behavioral: psychotherapyUsual Care therapists could use any treatment procedures they used regularly in their clinical practice. |
| Standard Manual Treatment (SMT) | Experimental | Behavioral: evidence-based treatmentEvidence-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). |
| Modular Maual Treatment (MMT) | Experimental | Behavioral: modular evidence-based treatmentTherapists 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. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychotherapyAlso: Treatment As Usual (TAU), Case ManagementUsual Care therapists could use any treatment procedures they used regularly in their clinical practice. | Behavioural | Usual Care Treatment |
| evidence-based treatmentAlso: best practices, evidence-based practices, treatment manualsEvidence-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). | Behavioural | Standard Manual Treatment (SMT) |
| modular evidence-based treatmentAlso: modular treatments, best practices, evidence-based practicesTherapists used the Modular Approach to Therapy for Children with Anxiety, Depression, or Conduct Problems (MATCH-ADC; Chorpita \& Weisz, 2004) | Behavioural | Modular Maual Treatment (MMT) |
Primary outcome
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.
10 secondary outcomes
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
Top Problems Assessment
Time frame: 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)
Child Behavior Checklist (CBCL)
Time frame: Change over time from Day 1 to Day 712 (24-mo follow-up)
Therapeutic Alliance Scale for Children
Time frame: 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)
Revised Children's Anxiety and Depression Scale
Time frame: Change over time from Day 1 to Day 267
Brief Symptom Inventory
Time frame: 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)
Services for Children & Adolescents - Parent Interview (SCAPI)
Time frame: Change over time from Day 1 to Day 712 (24-mo follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
- Background: PubMed 17987376Chorpita 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.
- Background: PubMed 19411357Borntrager 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.
- Background: PubMed 20700377Ebesutani 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.
- Background: PubMed 20658809Chorpita 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.
- Background: PubMed 19830545Ebesutani 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.
- BackgroundHo 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.
- BackgroundMartin 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.
- BackgroundPalinkas 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.
- Background: PubMed 18586990Palinkas 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.
- Derived from this study: PubMed 22065252Weisz 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.
- Child System and Treatment Enhancement ProjectsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R. Weisz, Ph.D. principal investigator
Judge Baker Children's Center
Bruce F. Chorpita, Ph.D. principal investigator
University of Hawaii
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychotherapy, evidence-based treatment and modular evidence-based treatment in people with Anxiety and Depression, run by Judge Baker Children's Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Problem Checklist (BPC, parent and child forms) (time frame: Change over time from Day 1 to Day 267). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01178554, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2011.