Connecticut Child STEPs

August 8, 2018 updated by: John Weisz, Harvard University

Child STEPs for Youth Mental Health in Connecticut

Connecticut Child STEPS is a randomized controlled trail investigating the effectiveness of MATCH-ADTC in treating anxiety, depression, trauma, and/or behavioral problems in children seeking services at four Department of Children and Families (DCF) funded clinics in the state of Connecticut. The study will evaluate child outcomes following two forms of therapist training in the MATCH model.

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

This randomized controlled trial (RCT) will investigate the effectiveness of a modular, transdiagnostic treatment protocol for youth with anxiety, depression, trauma, and/or behavioral problems (MATCH-ADTC) in four DCF funded clinics in the state of Connecticut. MATCH synthesizes common elements found across dozens of evidence-based treatments into one model that is flexible and responsive to the complex needs of children and families. The RCT will evaluate child outcomes following two forms of therapist training in the MATCH model: (1) the 6-day MATCH training only; (2) the 6-day MATCH training plus weekly ongoing case consultation with a MATCH consultant. Participating children are between the ages of 7 and 15.

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.
210

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
    • 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

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 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 7 to 15 year old child and their caregivers
  2. seeking services at community mental health clinics
  3. primary problem or disorder related to anxiety, traumatic stress, depression, or conduct problems, or any combination of the four problems

Exclusion Criteria:

  1. child is outside of 7-15 age range
  2. child does not have elevations in the areas of anxiety, depression, conduct, or posttraumatic stress

  3. child is experiencing other primary clinical problems outside of MATCH focus such as:

    • ADHD identified as primary reason for seeking treatment
    • Schizophrenic spectrum disorder including Major Depressive Disorder with psychotic features
    • Autism spectrum disorder including Pervasive Developmental Disorder, Asperger's Disorder, Child Disintegrative Disorder, Rett's Disorder
    • Eating disorder including Anorexia Nervosa and Bulimia Nervosa
    • Mental Retardation
  4. having been hospitalized for suicidal thoughts or behaviors within the past year
  5. if the problem area of focus is beyond the scope of outpatient treatment and MATCH (e.g., severe aggression, psychosis, severe current suicidal ideation)
  6. if child does not have a primary caregiver that can be involved in treatment and complete research assessments

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.
Experimental: MATCH Training plus MATCH Consultation
Therapists at local, community clinics attend a 6-day training on the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems (MATCH; Chorpita & Weisz, 2009). After the training, therapists participate in weekly consultation meetings that are led by a MATCH Consultant from the study team. MATCH Consultants review sessions and the clinical monitoring and feedback system, provide recommendations for upcoming sessions, and review MATCH modules via role-plays and models.
Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems
MATCH-ADTC (Chorpita & Weisz, 2009) is designed for children aged 6-15. Unlike most evidence-based treatments (EBTs), which focus on single disorder categories (e.g., anxiety only), MATCH is designed for multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD. 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:
  • MATCH
  • MATCH - ADTC
Other: Monitoring and Feedback System
For each child, the web-based MFS provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Brief Problem Monitor (BPM) and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, the MFS provides a complete record of modules used, and child treatment response, across all weeks of treatment.
Other Names:
  • MFS
Active Comparator: MATCH Training only
Therapists at local, community clinics attend a 6-day training on the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems (MATCH; Chorpita & Weisz, 2009). After the training, therapists use MATCH as they think best and receive supervision from supervisors at the clinic.
Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems
MATCH-ADTC (Chorpita & Weisz, 2009) is designed for children aged 6-15. Unlike most evidence-based treatments (EBTs), which focus on single disorder categories (e.g., anxiety only), MATCH is designed for multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD. 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:
  • MATCH
  • MATCH - ADTC
Other: Monitoring and Feedback System
For each child, the web-based MFS provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Brief Problem Monitor (BPM) and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, the MFS provides a complete record of modules used, and child treatment response, across all weeks of treatment.
Other Names:
  • MFS

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
Time Frame
Brief Problem Monitor (BPM)
Time Frame: Weekly from baseline to the end of treatment, and every three months therafter until 18 month follow-up
Weekly from baseline to the end of treatment, and every three months therafter until 18 month follow-up
Top Problems Assessment (TPA)
Time Frame: Weekly from baseline to the end of treatment, and every three months therafter until 18 month follow-up
Weekly from baseline to the end of treatment, and every three months therafter until 18 month follow-up

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
Time Frame
Therapist Satisfaction Inventory (TSI)
Time Frame: Change over time from Day 1 to end of treatment, an average of 22 weeks after baseline
Change over time from Day 1 to end of treatment, an average of 22 weeks after baseline
Youth Services Survey for Families (YSS-F)
Time Frame: Post-treatment, an average of 22 weeks after baseline
Post-treatment, an average of 22 weeks after baseline
Youth Self-Report and Child Behavior Checklist
Time Frame: Change over time from Day 1 to 18 month follow-up
Change over time from Day 1 to 18 month follow-up
Evidence-Based Practice Attitudes Scale (EBPAS)
Time Frame: Post-treatment, an average of 22 weeks after baseline
Post-treatment, an average of 22 weeks after baseline
Early Adolescent Temperament Questionnaire Revised (EATQ-R)
Time Frame: Change over time from Day 1 to 18 month follow-up
Change over time from Day 1 to 18 month follow-up
Child Satisfaction Survey (CSC)
Time Frame: Post-treatment, an average of 22 weeks after baseline
Post-treatment, an average of 22 weeks after baseline
Therapeutic Alliance Scale for Children (TASC)
Time Frame: Post-treatment, an average of 22 weeks after baseline
Post-treatment, an average of 22 weeks after baseline

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.
Harvard University

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, 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

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.
October 1, 2013

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.
June 1, 2018

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, 2018

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).
March 28, 2017

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.
May 12, 2017

First Posted (Actual)

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.
May 15, 2017

Study Record Updates

Last Update Posted (Actual)

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.
August 9, 2018

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.
August 8, 2018

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.
August 1, 2018

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.
  • 13-1904

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

Clinical Trials on Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings