AnxietyNCT03112304
Child STEPS for Youth Mental Health in Maine Sustainability
A study testing MATCH-ADTC and TRAC in people with Anxiety and Depression, run by Harvard University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Trauma
- What is being tested?
- MATCH-ADTC and TRAC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Aug 2015
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression, Trauma, Behavior Problems
- Being tested
- MATCH-ADTC, TRAC
- Keywords
- children, youth, adolescents, anxiety, depression, trauma, behavior problems, evidence-based treatments, manualized, cognitive-behavioral therapy, mental health
- Medical subject headings
- Anxiety Disorders, Depression, Wounds and Injuries, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MATCH-ADTCBehavioural
Also called MATCH
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.
TRACOther
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."
| Study group | Role | What they receive |
|---|---|---|
| MATCH-ADTC Wave 1 | Experimental | 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. Receives: Behavioral: MATCH-ADTC; Other: TRAC |
| MATCH-ADTC Wave 2 | Experimental | 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. Receives: Behavioral: MATCH-ADTC; Other: TRAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Problem Checklist (BPC)
Measured: Change over time from Day 1 to Day 242 (end of treatment)
Top Problems Assessment (TPA)
Measured: Change over time from Day 1 to Day 534 (18 month follow-up)
Secondary outcomes (6)
Youth Self-Report and Child Behavior Checklist
Measured: Change over time from Day 1 to Day 534 (18 month follow-up)
Therapeutic Alliance Scale for Children (TASC)
Measured: Change over time from Day 1 to Day 267(end of treatment)
Client Satisfaction Questionnaire- 8 (CSQ-8 )
Measured: Change over time from Day 1 to Day 267(end of treatment)
Youth Satisfaction Questionnaire-8 (YSQ-8)
Measured: Change over time from Day 1 to Day 267(end of treatment)
Therapist Satisfaction Inventory (TSI)
Measured: Change over time from Day 1 to Day 267(end of treatment)
Evidence-Based Practice Attitudes Scale (EBPAS)
Measured: Change over time from Day 1 to Day 267(end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startSep 2011
- Primary completionJul 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Weisz, Harvard University
- Investigators
- John R Weisz, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112304
- Sponsor's protocol ID
- H030711
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child STEPS for Youth Mental Health in Maine: Sustainability of MATCH in the Public Sector
- ClinicalTrials.gov ID
- NCT03112304
- Acronym / sponsor ID
- H030711
- Conditions
- Anxiety, Depression, Trauma, Behavior Problems
- Keywords
- children, youth, adolescents, anxiety, depression, trauma, behavior problems, evidence-based treatments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MATCH-ADTC Wave 1 | Experimental | Behavioral: MATCH-ADTC, Other: TRACWave 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 Wave 2 | Experimental | Behavioral: MATCH-ADTC, Other: TRACWave 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. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| MATCH-ADTCAlso: MATCHMATCH - 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. | Behavioural | MATCH-ADTC Wave 1, MATCH-ADTC Wave 2 |
| TRACTRAC (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." | Other | MATCH-ADTC Wave 1, MATCH-ADTC Wave 2 |
Primary outcome
Brief Problem Checklist (BPC)
Time frame: 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)
6 secondary outcomes
Youth Self-Report and Child Behavior Checklist
Time frame: 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)
Client Satisfaction Questionnaire- 8 (CSQ-8 )
Time frame: 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)
Therapist Satisfaction Inventory (TSI)
Time frame: 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)
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 13 Apr 2017.
- BackgroundChorpita, 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.
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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, PhD principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MATCH-ADTC and TRAC in people with Anxiety and Depression, run by Harvard University at 1 site 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 10 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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) (time frame: Change over time from Day 1 to Day 242 (end of treatment)). The study lists 2 primary outcomes in all. 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 NCT03112304, which also lists 1 linked publication.
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 13 Apr 2017.