Anxiety DisordersNCT03610373
Testing Psychosocial Treatment Planning Methods for Youth Anxiety and Depression
A study testing Modular Approach to Therapy for Children (MATCH) in people with Anxiety Disorders and Depressive Disorder, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Youth depression and anxiety represent a serious public health concern, with affected youth often experiencing social, familial, and academic impairment. Research evidence supports a growing array of effective treatments for youth depression and anxiety, yet as the collection of evidence-based treatments expands, so… Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder
- What is being tested?
- Modular Approach to Therapy for Children (MATCH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2016to 27 Aug 2019
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a current DSM-5 principal diagnosis of a Major Depressive Disorder, Dysthymic Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, or Specific Phobia
- if receiving psychiatric medication, dose will be stable for at least 3 months at enrollment with ability to maintain medication
- youth and caregiver speak fluent English
Who cannot join
- active suicidality
- history of severe physical or mental impairments (e.g., mental retardation, autism spectrum disorders) in youth or caregiver
- participation in additional psychosocial treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalizing Treatment Through Shared Decision Making for Youth Psychotherapy
Youth depression and anxiety represent a serious public health concern, with affected youth often experiencing social, familial, and academic impairment. Research evidence supports a growing array of effective treatments for youth depression and anxiety, yet as the collection of evidence-based treatments expands, so do the challenges of utilizing the evidence: clinicians must be able to (1) access, integrate, and apply the available evidence, and (2) engage in a collaborative process with each family to develop a plan that is responsive to each family's unique characteristics, preferences, and goals. Engaging caregivers and youths as active collaborators in the treatment planning process is a patient-centered approach with the potential to improve the process and outcome of youth mental health care by facilitating the personalization of established evidence-based treatment approaches. Such collaboration, frequently referred to as shared decision-making (SDM), is a hallmark of evidence-based practice and a key feature of federal guidelines for health care delivery. However, despite growing rhetorical support for SDM, empirical support is lacking, particularly in the area of youth mental health treatment. The absence of such research is unfortunate, given the potential for SDM to facilitate the dissemination and implementation of evidence-based treatments, and to personalize the use of established treatments to increase acceptability, retention, satisfaction, and overall effectiveness.
The present project tests the feasibility and acceptability of SDM through a pilot randomized controlled trial of 40 youths (ages 7-15) meeting diagnostic criteria for an anxiety or depressive disorder. The trial will compare an evidence-based treatment that is planned collaboratively with youths and caregivers using the SDM protocol, to an evidence-based treatment that is planned by the clinician and supervisor using pretreatment assessment data. Eligible youths will received up to 26 treatment sessions at no cost and complete assessments prior to the start of treatment, at the end of treatment, and six months following the end of treatment.
- Conditions
- Anxiety Disorders, Depressive Disorder
- Being tested
- Modular Approach to Therapy for Children (MATCH)
- Keywords
- anxiety, depression, childhood, therapy, treatment, medical decision making
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Depression
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 (MATCH)Behavioural
MATCH is a collection of 31 modules that correspond to the treatment procedures included in standard evidence-based treatments for youth depression, anxiety, and behavioral disorders.
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making | Experimental | In this arm, parents and children will participate in a shared decision-making protocol with the clinician to plan their treatment. The treatment options available are established, evidence-based treatment techniques. The shared decision-making protocol was developed for this research project. Receives: Behavioral: Modular Approach to Therapy for Children (MATCH) |
| Clinician Guided | Active comparator | In this arm, the clinician will plan the treatment in consultation with their supervisor, and share the treatment plan with the parent and child. The parent and child will have the opportunity to ask questions about the treatment plan (and, if they do not agree, reject the treatment plan), but they are not actively involved in making each decision. This is more typical of usual care. Receives: Behavioral: Modular Approach to Therapy for Children (MATCH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent
The Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent is an extensively tested semi-structured interview assessing the major anxiety, mood, and externalizing disorders.
Measured: Through completion of treatment, anticipated to be an average of 5 months
Secondary outcomes (1)
Satisfaction with Decision Scale
The 6-item Satisfaction with Decision Scale assesses satisfaction with treatment-related decisions. The scale score ranges from 6 (very low satisfaction) to 30 (very high satisfaction).
Measured: At the start of treatment, anticipated to be an average of 3 weeks after the initial assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start4 Oct 2016
- Primary completion20 Feb 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to receive a treatment planned primarily by the clinician (clinician guided) or planned collaboratively by the clinician, parent, and child (shared decision-making).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David A. Langer, Boston University Charles River Campus
- Investigators
- David A Langer, Ph.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610373
- Sponsor's protocol ID
- 3462
- Other IDs
- K23MH101238
- Status last verified
- Jan 2020
- First submitted
- 29 Jun 2018
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Treatment Through Shared Decision Making for Youth Psychotherapy
- ClinicalTrials.gov ID
- NCT03610373
- Acronym / sponsor ID
- 3462
- Conditions
- Anxiety Disorders, Depressive Disorder
- Keywords
- anxiety, depression, childhood, therapy, treatment, medical decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 1 Aug 2018 (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.
Youth depression and anxiety represent a serious public health concern, with affected youth often experiencing social, familial, and academic impairment. Research evidence supports a growing array of effective treatments for youth depression and anxiety, yet as the collection of evidence-based treatments expands, so do the challenges of utilizing the evidence: clinicians must be able to (1) access, integrate, and apply the available evidence, and (2) engage in a collaborative process with each family to develop a plan that is responsive to each family's unique characteristics, preferences, and goals. Engaging caregivers and youths as active collaborators in the treatment planning process is a patient-centered approach with the potential to improve the process and outcome of youth mental health care by facilitating the personalization of established evidence-based treatment approaches. Such collaboration, frequently referred to as shared decision-making (SDM), is a hallmark of evidence-based practice and a key feature of federal guidelines for health care delivery. However, despite growing rhetorical support for SDM, empirical support is lacking, particularly in the area of youth mental health treatment. The absence of such research is unfortunate, given the potential for SDM to facilitate the dissemination and implementation of evidence-based treatments, and to personalize the use of established treatments to increase acceptability, retention, satisfaction, and overall effectiveness.
The present project tests the feasibility and acceptability of SDM through a pilot randomized controlled trial of 40 youths (ages 7-15) meeting diagnostic criteria for an anxiety or depressive disorder. The trial will compare an evidence-based treatment that is planned collaboratively with youths and caregivers using the SDM protocol, to an evidence-based treatment that is planned by the clinician and supervisor using pretreatment assessment data. Eligible youths will received up to 26 treatment sessions at no cost and complete assessments prior to the start of treatment, at the end of treatment, and six months following the end of treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to receive a treatment planned primarily by the clinician (clinician guided) or planned collaboratively by the clinician, parent, and child (shared decision-making).
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making | Experimental | Behavioral: Modular Approach to Therapy for Children (MATCH)In this arm, parents and children will participate in a shared decision-making protocol with the clinician to plan their treatment. The treatment options available are established, evidence-based treatment techniques. The shared decision-making protocol was developed for this research project. |
| Clinician Guided | Active comparator | Behavioral: Modular Approach to Therapy for Children (MATCH)In this arm, the clinician will plan the treatment in consultation with their supervisor, and share the treatment plan with the parent and child. The parent and child will have the opportunity to ask questions about the treatment plan (and, if they do not agree, reject the treatment plan), but they are not actively involved in making each decision. This is more typical of usual care. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- a current DSM-5 principal diagnosis of a Major Depressive Disorder, Dysthymic Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, or Specific Phobia
- if receiving psychiatric medication, dose will be stable for at least 3 months at enrollment with ability to maintain medication
- youth and caregiver speak fluent English
Key exclusion criteria (3 listed)
- active suicidality
- history of severe physical or mental impairments (e.g., mental retardation, autism spectrum disorders) in youth or caregiver
- participation in additional psychosocial treatment
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 (MATCH)MATCH is a collection of 31 modules that correspond to the treatment procedures included in standard evidence-based treatments for youth depression, anxiety, and behavioral disorders. | Behavioural | Clinician Guided, Shared Decision Making |
Primary outcome
Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent
Time frame: Through completion of treatment, anticipated to be an average of 5 months
The Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent is an extensively tested semi-structured interview assessing the major anxiety, mood, and externalizing disorders.
1 secondary outcome
Satisfaction with Decision Scale
Time frame: At the start of treatment, anticipated to be an average of 3 weeks after the initial assessment
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 28 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
David A Langer, Ph.D. principal investigator
Boston 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 (MATCH) in people with Anxiety Disorders and Depressive Disorder, run by Boston University Charles River Campus 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 3 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 28 Jan 2020. 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?
Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent (time frame: Through completion of treatment, anticipated to be an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2020.