- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03112304
Child STEPS for Youth Mental Health in Maine Sustainability
April 7, 2017 updated by: John Weisz, Harvard University
Child STEPS for Youth Mental Health in Maine: Sustainability of MATCH in the Public Sector
The overarching goal of this project is to study the sustainability of MATCH-ADTC within community mental health clinics, to learn what is needed for evidence-based practices (EBPs) to take root and thrive within a public system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this project, the investigators are randomizing children to Wave 1 (previously MATCH trained) or Wave 2 (newly MATCH trained) and using a clinical monitoring system (TRAC) to measure youth outcomes over time.
Participating therapists receive weekly MATCH consultation provided by the Judge Baker Children's Center/Harvard University research team or by Maine clinic supervisors who are MATCH Associate Consultants.
The investigators are also developing and testing new low-cost measures of MATCH treatment and consultation fidelity to explore the feasibility of more sustainable measures of MATCH adherence.
Study data will be used to answer questions about the sustainability of MATCH in the public sector.
Study Type
Interventional
Enrollment (Actual)
153
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
-
-
Massachusetts
-
Cambridge, Massachusetts, United States, 02138
- Harvard University
-
-
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
6 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 6 - 15 year old child and their caregivers
- seeking services at community mental health clinics
- primary problem or disorder related to anxiety, traumatic stress, depression, or conduct problems, or any combination of the four problems
Exclusion Criteria:
- child is younger than 6 years or older than 15 years on the day of the phone screen.
- child has attempted suicide within the past year.
- Schizophrenic spectrum disorder (including MDD with psychotic features)
- Autism or another Pervasive Developmental Disorder (E.g., PDD NOS, Asperger's Disorder, Child Disintegration 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 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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MATCH-ADTC Wave 1
Wave 1 clinicians received MATCH training at the beginning of the project and used MATCH to treat participating children from their clinic for two years, with weekly case consultation from MATCH experts who were part of the study team, and then received consultation from their own clinic supervisors who had been trained as MATCH Associate Consultants (ACs), supported by the TRAC system.
|
MATCH - ADTC (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems; Chorpita & Weisz, 2009) is a psychosocial intervention designed to treat children with multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD.
It is recommended for children aged 6-15.
MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs.
The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.
Other Names:
TRAC (Treatment Response Assessment for Children) is a web-based system that provides weekly monitoring of the MATCH modules used and the child's response to treatment.
Child's response to treatment is based on caregiver and child reports of (a) changes in problem severity on the standardized Brief Problem Checklist, and (b) changes in severity of the top treatment concerns identified by youths and caregivers.
At the end of treatment, TRAC provides a complete record of modules used, and child treatment response, across all the weeks of treatment, as illustrated in the "client dashboard."
|
|
Experimental: MATCH-ADTC Wave 2
Wave 2 clinicians provided treatment as usual (e.g., usual care) with the children they treated during the initial two years of the project.
Afterwards, they trained in MATCH and used it to treat children in their clinics with weekly case consultation from our study team of MATCH experts, supported by the TRAC system.
|
MATCH - ADTC (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems; Chorpita & Weisz, 2009) is a psychosocial intervention designed to treat children with multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD.
It is recommended for children aged 6-15.
MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs.
The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.
Other Names:
TRAC (Treatment Response Assessment for Children) is a web-based system that provides weekly monitoring of the MATCH modules used and the child's response to treatment.
Child's response to treatment is based on caregiver and child reports of (a) changes in problem severity on the standardized Brief Problem Checklist, and (b) changes in severity of the top treatment concerns identified by youths and caregivers.
At the end of treatment, TRAC provides a complete record of modules used, and child treatment response, across all the weeks of treatment, as illustrated in the "client dashboard."
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Brief Problem Checklist (BPC)
Time Frame: Change over time from Day 1 to Day 242 (end of treatment)
|
Change over time from Day 1 to Day 242 (end of treatment)
|
|
Top Problems Assessment (TPA)
Time Frame: Change over time from Day 1 to Day 534 (18 month follow-up)
|
Change over time from Day 1 to Day 534 (18 month follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Youth Self-Report and Child Behavior Checklist
Time Frame: Change over time from Day 1 to Day 534 (18 month follow-up)
|
Change over time from Day 1 to Day 534 (18 month follow-up)
|
|
Therapeutic Alliance Scale for Children (TASC)
Time Frame: Change over time from Day 1 to Day 267(end of treatment)
|
Change over time from Day 1 to Day 267(end of treatment)
|
|
Client Satisfaction Questionnaire- 8 (CSQ-8 )
Time Frame: Change over time from Day 1 to Day 267(end of treatment)
|
Change over time from Day 1 to Day 267(end of treatment)
|
|
Youth Satisfaction Questionnaire-8 (YSQ-8)
Time Frame: Change over time from Day 1 to Day 267(end of treatment)
|
Change over time from Day 1 to Day 267(end of treatment)
|
|
Therapist Satisfaction Inventory (TSI)
Time Frame: Change over time from Day 1 to Day 267(end of treatment)
|
Change over time from Day 1 to Day 267(end of treatment)
|
|
Evidence-Based Practice Attitudes Scale (EBPAS)
Time Frame: Change over time from Day 1 to Day 267(end of treatment)
|
Change over time from Day 1 to Day 267(end of treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John R Weisz, PhD, Harvard University
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, B.F., & Weisz, J.R. (2009). Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC). Satellite Beach, FL: PracticeWise, LLC.
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
September 1, 2011
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
March 28, 2017
First Submitted That Met QC Criteria
April 7, 2017
First Posted (Actual)
April 13, 2017
Study Record Updates
Last Update Posted (Actual)
April 13, 2017
Last Update Submitted That Met QC Criteria
April 7, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H030711
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.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
Fondation FondaMentalGYNOVNot yet recruitingDepression | Depression in Adults | Depression DisorderFrance
Clinical Trials on MATCH-ADTC
-
Harvard UniversityCompleted
-
University of GuelphCentre for Addiction and Mental Health; Canadian Institutes of Health Research...RecruitingDepressive Disorder | Mood Disorders | Anxiety Disorders | Trauma and Stressor Related Disorders | Conduct Disorder | Oppositional Defiant Disorder | Child Behavior Disorders | Regulation, EmotionCanada
-
Harvard UniversityCompletedDepression | Anxiety | Trauma | Behavior ProblemsUnited States
-
Harvard UniversityCompletedDepression | Anxiety | Trauma | Behavior ProblemsUnited States
-
University of Massachusetts, AmherstPatient-Centered Outcomes Research Institute; University at Albany; Psychological... and other collaboratorsCompletedMental IllnessUnited States
-
University of PennsylvaniaHarvard University; Carnegie Mellon University; incentaHEALTH; McKinsey & CompanyCompleted
-
University of California, San DiegoRady Children's Hospital, San Diego; Gordon and Marilyn Macklin FoundationRecruiting
-
University of ChicagoChicago Public Schools; U.S. Department of Justice; MacArthur Foundation; Crown... and other collaboratorsUnknownYouth Violence | Crime | Educational AchievementUnited States
-
University of Alabama at BirminghamCompletedDisability Physical | Physical InactivityUnited States
-
AstraZenecaCompleted