AnxietyNCT03112265
Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes
A study testing Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems, Monitoring and Feedback System and Treatment as usual in people with Anxiety and Depression, run by Harvard University at 1 site in United States.
Trial summary
The study will compare the impact of Child STEPs versus usual school-based therapy on neural and companion behavioral measures of self-regulation. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Trauma
- What is being tested?
- Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems, Monitoring and Feedback System and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 31 Jul 2020
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- enrolled in grades 3-7
- have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress
- clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress Disorder Reaction Index.
Who cannot join
- Mental retardation
- Pervasive developmental disorder
- Eating disorder
- children for whom attention problems or hyperactivity are the primary referral concern
- active psychosis and/or a suicide attempt in the previous year
- To participate in the two neuroimaging tasks (Emotion Regulation Task; Emotional Go/No Go Task), participants must be healthy (no major medical illness), right-handed, fluent in English, have no history of neurological impairment (including but not limited to history of loss of consciousness for great than 20 minutes, seizures, stroke, etc.), have normal or corrected to normal vision, and have no contra-indications or risk factors for MRI research (such as braces or metal implants).
Trial locations and contacts
1 site in 1 country.
About this study
The study will compare the impact of Child STEPs versus usual school-based therapy on neural and companion behavioral measures of self-regulation.
Read the detailed description
This project will implement and evaluate the Child STEPs treatment approach as compared to "treatment as usual" (known as Usual Care or UC) through a randomized controlled trial (RCT) at eight K-8 public schools. The STEPs model has two components: (1) a modular protocol that combines 33 modules-i.e., descriptions of common elements within evidence-based therapies for anxiety, depression, post-traumatic stress, and conduct problems; and (2) a web-based system for monitoring student responses to treatment and providing weekly feedback to therapists to guide their selection and sequencing of the STEPs modules. The project will examine: (a) whether self-regulation skills at baseline are associated with baseline patterns of mental health and school problems; (b) whether self-regulation skills at baseline predict degree of improvement during treatment; (c) whether self-regulation skills improve from pre-to post treatment, and whether extent of this improvement differs by treatment condition; and (d) whether self-regulation improvement (from pre-to-post treatment) mediates the long-term benefit of treatment.
- Conditions
- Anxiety, Depression, Trauma, Behavior Problems
- Being tested
- Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems, Monitoring and Feedback System, Treatment as usual
- Keywords
- anxiety, depression, trauma, behavior problems, evidence-based treatments, manualized treatments, cognitive-behavioral therapy, youth, mental health, self-regulation, neuroimaging
- Medical subject headings
- Anxiety Disorders, Depression, Wounds and Injuries, Mental Disorders, Psychological Well-Being, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct ProblemsBehavioural
Also called MATCH, MATCH - ADTC
MATCH-ADTC 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.
Monitoring and Feedback SystemOther
Also called MFS
For each child, the web-based MFS system provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Behavior and Emotions Survey 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 the weeks of treatment.
Treatment as usualBehavioural
Also called Usual Care, UC
Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective.
| Study group | Role | What they receive |
|---|---|---|
| Child STEPS | Experimental | Child STEPs includes (1) a treatment protocol, Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems (MATCH-ADTC), and (2) a youth monitoring and feedback system (MFS). Receives: Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems; Other: Monitoring and Feedback System |
| Usual Care | Active comparator | Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective, and researchers will not influence their work. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Emotion Regulation Task at End of Treatment
Measured: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Emotional Go/No-Go Task at End of Treatment
Measured: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Secondary outcomes (4)
Change from Baseline Attentional Bias Task at End of Treatment
Measured: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Granularity Task at End of Treatment
Measured: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Behavior Rating Inventory of Executive Function (BRIEF) at End of Treatment
Measured: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Early Adolescent Temperament Questionnaire Revised (EATQ-R) at End of Treatment
Measured: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
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 startJan 2015
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 100 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
- NCT03112265
- Sponsor's protocol ID
- 313704
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2017
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weisz 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 22065252Chorpita, 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes
- ClinicalTrials.gov ID
- NCT03112265
- Acronym / sponsor ID
- 313704
- Conditions
- Anxiety, Depression, Trauma, Behavior Problems
- Keywords
- anxiety, depression, trauma, behavior problems, evidence-based treatments, manualized treatments, cognitive-behavioral therapy, youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (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 study will compare the impact of Child STEPs versus usual school-based therapy on neural and companion behavioral measures of self-regulation.
Detailed description
This project will implement and evaluate the Child STEPs treatment approach as compared to "treatment as usual" (known as Usual Care or UC) through a randomized controlled trial (RCT) at eight K-8 public schools. The STEPs model has two components: (1) a modular protocol that combines 33 modules-i.e., descriptions of common elements within evidence-based therapies for anxiety, depression, post-traumatic stress, and conduct problems; and (2) a web-based system for monitoring student responses to treatment and providing weekly feedback to therapists to guide their selection and sequencing of the STEPs modules. The project will examine: (a) whether self-regulation skills at baseline are associated with baseline patterns of mental health and school problems; (b) whether self-regulation skills at baseline predict degree of improvement during treatment; (c) whether self-regulation skills improve from pre-to post treatment, and whether extent of this improvement differs by treatment condition; and (d) whether self-regulation improvement (from pre-to-post treatment) mediates the long-term benefit of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child STEPS | Experimental | Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems, Other: Monitoring and Feedback SystemChild STEPs includes (1) a treatment protocol, Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems (MATCH-ADTC), and (2) a youth monitoring and feedback system (MFS). |
| Usual Care | Active comparator | Behavioral: Treatment as usualTreatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective, and researchers will not influence their work. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- enrolled in grades 3-7
- have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress
- clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress Disorder Reaction Index.
Key exclusion criteria (6 listed)
- Mental retardation
- Pervasive developmental disorder
- Eating disorder
- children for whom attention problems or hyperactivity are the primary referral concern
- active psychosis and/or a suicide attempt in the previous year
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 |
|---|---|---|
| Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct ProblemsAlso: MATCH, MATCH - ADTCMATCH-ADTC 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. | Behavioural | Child STEPS |
| Monitoring and Feedback SystemAlso: MFSFor each child, the web-based MFS system provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Behavior and Emotions Survey 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 the weeks of treatment. | Other | Child STEPS |
| Treatment as usualAlso: Usual Care, UCTreatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective. | Behavioural | Usual Care |
Primary outcome
Change from Baseline Emotion Regulation Task at End of Treatment
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Emotional Go/No-Go Task at End of Treatment
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
4 secondary outcomes
Change from Baseline Attentional Bias Task at End of Treatment
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Granularity Task at End of Treatment
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Behavior Rating Inventory of Executive Function (BRIEF) at End of Treatment
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Early Adolescent Temperament Questionnaire Revised (EATQ-R) at End of Treatment
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
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 10 Mar 2021.
- Background: 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.
- 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 Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems, Monitoring and Feedback System and Treatment as usual 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 6 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 10 Mar 2021. 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?
Change from Baseline Emotion Regulation Task at End of Treatment (time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks). 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 NCT03112265, which also lists 2 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 10 Mar 2021.