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Connecticut Child STEPs

Primary Purpose

Anxiety, Depression, Trauma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Monitoring and Feedback System

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, depression, trauma, behavior problems, evidence-based treatments, manualized treatments, cognitive-behavioral therapy, youth, mental health

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

7 to 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 outside of 7-15 age range
child does not have elevations in the areas of anxiety, depression, conduct, or posttraumatic stress
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
having been hospitalized for suicidal thoughts or behaviors within the past year
if the problem area of focus is beyond the scope of outpatient treatment and MATCH (e.g., severe aggression, psychosis, severe current suicidal ideation)
if child does not have a primary caregiver that can be involved in treatment and complete research assessments

Sites / Locations

Harvard University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MATCH Training plus MATCH Consultation

MATCH Training only

Arm Description

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.

Outcomes

Primary Outcome Measures

Brief Problem Monitor (BPM)

Secondary Outcome Measures

Therapist Satisfaction Inventory (TSI)

Youth Services Survey for Families (YSS-F)

Youth Self-Report and Child Behavior Checklist

Evidence-Based Practice Attitudes Scale (EBPAS)

Early Adolescent Temperament Questionnaire Revised (EATQ-R)

Child Satisfaction Survey (CSC)

Therapeutic Alliance Scale for Children (TASC)

Full Information

NCT ID

NCT03153904

First Posted

March 28, 2017

Last Updated

August 8, 2018

Sponsor

Harvard University

1. Study Identification

Unique Protocol Identification Number

NCT03153904

Brief Title

Connecticut Child STEPs

Official Title

Child STEPs for Youth Mental Health in Connecticut

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harvard University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Depression, Trauma, Behavior Problems

Keywords

anxiety, depression, trauma, behavior problems, evidence-based treatments, manualized treatments, cognitive-behavioral therapy, youth, mental health

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MATCH Training plus MATCH Consultation

Arm Type

Experimental

Arm Description

Arm Title

MATCH Training only

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

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

Other Intervention Name(s)

MATCH, MATCH - ADTC

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Monitoring and Feedback System

Other Intervention Name(s)

MFS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Brief Problem Monitor (BPM)

Time Frame

Weekly from baseline to the end of treatment, and every three months therafter until 18 month follow-up

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 7 to 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 outside of 7-15 age range child does not have elevations in the areas of anxiety, depression, conduct, or posttraumatic stress 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 having been hospitalized for suicidal thoughts or behaviors within the past year if the problem area of focus is beyond the scope of outpatient treatment and MATCH (e.g., severe aggression, psychosis, severe current suicidal ideation) if child does not have a primary caregiver that can be involved in treatment and complete research assessments

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John R Weisz, PhD

Organizational Affiliation

Harvard University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Harvard University

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02138

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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.

Results Reference

background

PubMed Identifier

33935825

Citation

Evans SC, Wei MA, Harmon SL, Weisz JR. Modular Psychotherapy Outcomes for Youth With Different Latent Profiles of Irritability and Emotion Dysregulation. Front Psychiatry. 2021 Apr 16;12:618455. doi: 10.3389/fpsyt.2021.618455. eCollection 2021.

Results Reference

derived

PubMed Identifier

33370131

Citation

Weisz JR, Thomassin K, Hersh J, Santucci LC, MacPherson HA, Rodriguez GM, Bearman SK, Lang JM, Vanderploeg JJ, Marshall TM, Lu JJ, Jensen-Doss A, Evans SC. Clinician training, then what? Randomized clinical trial of child STEPs psychotherapy using lower-cost implementation supports with versus without expert consultation. J Consult Clin Psychol. 2020 Dec;88(12):1065-1078. doi: 10.1037/ccp0000536.

Results Reference

derived

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Connecticut Child STEPs

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