Adolescent BehaviorMTFS-FT-CBTNCT03722654
Measurement Training and Feedback System: Family Therapy and CBT
A study testing MTFS-I Installation in people with Adolescent Behavior, run by The National Center on Addiction and Substance Abuse at Columbia University at 3 sites in United States.
Trial summary
This study aims to advance the science of mental health services for adolescent externalizing problems (AEPs) by developing therapist training procedures to increase fidelity to evidence-based interventions (EBIs) in usual care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adolescent Behavior
- What is being tested?
- MTFS-I Installation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2020to 30 Jun 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Therapists treating adolescents aged 12-21 at partnering treatment sites
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roberto Clemente Center
New York, New York, 10009
The LGBT Community Center
New York, New York, 10011
Montefiore
New York, New York, 10461
About this study
Official title: Measurement Training and Feedback System for Implementation of Family Therapy and CBT for Adolescent Externalizing Problems
This study aims to advance the science of mental health services for adolescent externalizing problems (AEPs) by developing therapist training procedures to increase fidelity to evidence-based interventions (EBIs) in usual care. Two widely endorsed approaches are consistently effective for treating AEPs: family therapy and CBT. Importantly, stronger fidelity to core EBIs of these approaches predicts better outcomes in research and community settings. Yet these EBIs are not widely implemented with fidelity. To help close this quality gap in adolescent services, investigators will develop an online intervention to strengthen fidelity to these EBIs in routine care: Measurement Training and Feedback System for implementation (MTFS-I). MTFS-I will target two essential aspects of EBI fidelity: Training components will seek to improve EBI self-monitoring, and a Feedback component will seek to increase EBI utilization. In keeping with NIMH's Experimental Therapeutics paradigm, this study will examine whether an Intervention (MTFS-I) has direct impact on immediate Targets (EBI self-monitoring and utilization).
If promising, future R01 studies will examine links among intervention, targets, and ultimate outcomes (AEPs). The MTFS-I package will be an online quality assurance system completed by therapists and supervisors that can be readily sustained in usual care. Two weekly Training components will adapt gold-standard observational fidelity coding procedures to promote improved self-monitoring of the targeted EBIs, and a monthly Feedback component will adapt a measurement feedback system to promote increased utilization of these EBIs in everyday practice. To maximize provider investment, sites will delineate their own fidelity standards for family therapy and CBT and help design feedback report templates.
The proposed study will be among the first to (1) test whether training therapists in observational assessment of EBI fidelity increases the accuracy with which they self-monitor use of those EBIs and (2) adapt measurement feedback procedures to track and improve therapist utilization of EBIs. To achieve study aims the investigators will first partner with two community clinics to develop sustainable MTFS-I procedures using a three-phase Pilot process. Investigators will then initiate an experimental Trial during which therapists (n = 32, treating 192 clients) at four different clinics will be randomized to MTFS-I versus no-intervention Control. In both conditions two kinds of data will be collected: therapist-report checklists on use of core family therapy and CBT techniques with adolescent cases and treatment session audio recordings. MTFS-I uptake will be tracked electronically for online components (Aim 1: MTFS feasibility). Session recordings will be coded by observers for three facets of EBI fidelity: adherence (extent of EBI utilization), working alliance, and therapist competence. Observer ratings will measure the strength of EBI self-monitoring (Aim 2: therapist reliability and accuracy) and fidelity (Aim 3 [EBI utilization] \& Aim 4 [alliance, competence]). If effective, MTFS-I could be adapted to promote EBI fidelity for a variety of clinical populations and approaches.
Read the detailed description
Discovering and disseminating effective methods to improve the quality of available treatment services for adolescent externalizing problems is an urgent public health priority. Despite the strong legislative and policy focus on quality of care evident in the CHIP Reauthorization Act of 2009 and the Affordable Care Act of 2010, comprehensive reports underscore the enduring "quality chasm" between behavioral treatments proven in controlled research versus those commonly practiced in usual care. The quality gap is highly evident for adolescent externalizing problems (AEPs), which encompass serious conduct problems, delinquency, and substance misuse. AEPs are the most common adolescent behavioral issues in specialty care, which follows from high prevalence rates: conduct disorder has a 9.5% lifetime prevalence rate, and 19% of adolescents report past-year illicit drug use with 7% meeting criteria for psychiatric disorder. Yet standard treatment quality for AEPs is considered mediocre to inadequate due to a host of factors headlined by the absence or modest quality of evidence-based services, insufficient provider training, and little quality monitoring.
Two behavioral treatment approaches are prime candidates for upgrading the quality of AEP treatment services. Both family therapy (FT) and cognitive-behavioral therapy (CBT) have excellent efficacy evidence for AEPs in both research and community settings. Each has strong support for treating serious conduct problems, delinquency, and substance use, and each has several manualized versions proven efficacious across the AEP range. Due to this extensive evidence base, there is incentive from clinical providers and payers to deliver these approaches in routine care: Both are now approved for treating AEPs by federal and private insurance plans and by regulatory agencies that govern licensed treatment providers. Notably, therapists report that both approaches are highly valued in everyday practice.
By consensus, the most efficient pathway toward improving the quality of mental health services is to increase the adoption and delivery of evidence-based interventions (EBIs) in usual care. However, there is a caveat: For EBIs to be effective in frontline settings, they must be delivered with sufficient fidelity to the principles and procedures of the approaches they represent. This remains a most difficult challenge for which innovative solutions are sorely needed. With regard to AEPs, controlled studies have shown that strong fidelity to the FT and CBT approaches predicts improved client outcomes in both efficacy and effectiveness studies. Yet, at this time, neither FT nor CBT are widely implemented with fidelity in community clinics that treat AEPs. To promote EBI fidelity as a core virtue of the behavioral care system, the study team published a theoretical model in which EBI implementation is recognized as an essential driver of positive client outcomes. This model includes structural characteristics of care that directly influence both implementation and outcomes, as well as outcomes considered relevant within the "quality of care" framework. The middle section depicts elements of implementation that have proven salient for effective EBI delivery, including technical factors (adherence to core treatment techniques, therapist competence) and relational factors (e.g., alliance), given that both are related to outcomes. According to this model and similar others, EBI implementation fidelity is a multidimensional construct with three primary facets: Adherence (extent to which signature EBI techniques are utilized), Competence (skillfulness and responsiveness of EBI delivery), and Alliance (working relationship between provider and client). In AEP research, fidelity-outcome studies consistently find that stronger EBI adherence and stronger alliance predict better client outcomes. Evidence for competence-outcome effects is less consistent, in large part because competence remains difficult to operationalize reliably. According to this framework, innovations aimed at improving service quality should directly target EBI fidelity; stronger EBI fidelity will then boost client outcome.
- Conditions
- Adolescent Behavior
- Being tested
- MTFS-I Installation
- Keywords
- Adolescents, Conduct problems, Delinquency, Substance misuse
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTFS-I InstallationBehavioural
MTFS-I Installation will focus on introducing MTFS-I components including weekly training modules and mock video segments to be coded, as well as monthly feedback reports summarizing therapist self-reported FT and CBT implementation in active cases. Facilitation will also be included to review progress and provide regular support.
| Study group | Role | What they receive |
|---|---|---|
| MTFS | Experimental | MTFS-I Installation Receives: Behavioral: MTFS-I Installation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EBI Fidelity: ITT-ABP Therapist-Report
Inventory of Therapy Techniques for Adolescent Behavior Problems is a 24-item, post-session, therapist-report fidelity tool that meets key criteria for pragmatic measures: relevance to stakeholders, low burden, broad applicability, strong psychometrics, and useful for data-driven decision-making (actionable). It requires 2-3 minutes to complete and was derived from validated observational fidelity tools for manualized treatments via a stakeholder-informed instrument adaptation process. The FT and CBT items each measure the adherence (i.e., thoroughness and frequency) with which each technique was used based on a 5-point Likert-type scale: 0 = Not at all, 1 = A little bit, 2 = Moderately, 3 = Considerably, 4 = Extensively.
Measured: Conclusion of every session for 1 year
Secondary outcomes (1)
EBI Fidelity: ITT-ABP Observational Version
The ITT-ABP observational version mirrors the therapist-report version, with the addition of two items. To capture Competence, we will use a single item (identical 5-point scoring scale): "Please rate the extent to which you were skillful and responsive in today's session". Competence is difficult to judge reliably even for trained coders. Nonetheless, we have had moderate success in coding Competence with a single item for both EBIs via the observational version of ITT-ABP: ICC = .55 for FT and .56 for CBT, 58. To capture Alliance, we will use the VTAS-R Short Form, a 5-item observational measure of therapeutic alliance, defined as the collaborative working relationship in therapy. The VTAS-R Short Form has likewise shown strong internal consistency, high correlations with the full-length VTAS-R, and predictive validity for retention and clinical outcomes for AEPs.
Measured: Through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Sep 2020
- Primary completion1 Jun 2022
- Study completion30 Jun 2022
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 Adolescent BehaviorStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Aaron Hogue, PhD, Principal investigator, The Center on Addiction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722654
- Sponsor's protocol ID
- R34MH117212
- Acronym
- MTFS-FT-CBT
- Status last verified
- Aug 2023
- First submitted
- 24 Oct 2018
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hogue A, Bobek M, MacLean A, Porter N, Jensen-Doss A, Henderson CE. Measurement training and feedback system for implementation of evidence-based treatment for adolescent externalizing problems: protocol for a randomized trial of pragmatic clinician training. Trials. 2019 Dec 10;20(1):700. doi: 10.1186/s13063-019-3783-8.
PubMed 31822294
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement Training and Feedback System for Implementation of Family Therapy and CBT for Adolescent Externalizing Problems
- ClinicalTrials.gov ID
- NCT03722654
- Acronym / sponsor ID
- MTFS-FT-CBT / R34MH117212
- Conditions
- Adolescent Behavior
- Keywords
- Adolescents, Conduct problems, Delinquency, Substance misuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Oct 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.
This study aims to advance the science of mental health services for adolescent externalizing problems (AEPs) by developing therapist training procedures to increase fidelity to evidence-based interventions (EBIs) in usual care. Two widely endorsed approaches are consistently effective for treating AEPs: family therapy and CBT. Importantly, stronger fidelity to core EBIs of these approaches predicts better outcomes in research and community settings. Yet these EBIs are not widely implemented with fidelity. To help close this quality gap in adolescent services, investigators will develop an online intervention to strengthen fidelity to these EBIs in routine care: Measurement Training and Feedback System for implementation (MTFS-I). MTFS-I will target two essential aspects of EBI fidelity: Training components will seek to improve EBI self-monitoring, and a Feedback component will seek to increase EBI utilization. In keeping with NIMH's Experimental Therapeutics paradigm, this study will examine whether an Intervention (MTFS-I) has direct impact on immediate Targets (EBI self-monitoring and utilization).
If promising, future R01 studies will examine links among intervention, targets, and ultimate outcomes (AEPs). The MTFS-I package will be an online quality assurance system completed by therapists and supervisors that can be readily sustained in usual care. Two weekly Training components will adapt gold-standard observational fidelity coding procedures to promote improved self-monitoring of the targeted EBIs, and a monthly Feedback component will adapt a measurement feedback system to promote increased utilization of these EBIs in everyday practice. To maximize provider investment, sites will delineate their own fidelity standards for family therapy and CBT and help design feedback report templates.
The proposed study will be among the first to (1) test whether training therapists in observational assessment of EBI fidelity increases the accuracy with which they self-monitor use of those EBIs and (2) adapt measurement feedback procedures to track and improve therapist utilization of EBIs. To achieve study aims the investigators will first partner with two community clinics to develop sustainable MTFS-I procedures using a three-phase Pilot process. Investigators will then initiate an experimental Trial during which therapists (n = 32, treating 192 clients) at four different clinics will be randomized to MTFS-I versus no-intervention Control. In both conditions two kinds of data will be collected: therapist-report checklists on use of core family therapy and CBT techniques with adolescent cases and treatment session audio recordings. MTFS-I uptake will be tracked electronically for online components (Aim 1: MTFS feasibility). Session recordings will be coded by observers for three facets of EBI fidelity: adherence (extent of EBI utilization), working alliance, and therapist competence. Observer ratings will measure the strength of EBI self-monitoring (Aim 2: therapist reliability and accuracy) and fidelity (Aim 3 [EBI utilization] \& Aim 4 [alliance, competence]). If effective, MTFS-I could be adapted to promote EBI fidelity for a variety of clinical populations and approaches.
Detailed description
Discovering and disseminating effective methods to improve the quality of available treatment services for adolescent externalizing problems is an urgent public health priority. Despite the strong legislative and policy focus on quality of care evident in the CHIP Reauthorization Act of 2009 and the Affordable Care Act of 2010, comprehensive reports underscore the enduring "quality chasm" between behavioral treatments proven in controlled research versus those commonly practiced in usual care. The quality gap is highly evident for adolescent externalizing problems (AEPs), which encompass serious conduct problems, delinquency, and substance misuse. AEPs are the most common adolescent behavioral issues in specialty care, which follows from high prevalence rates: conduct disorder has a 9.5% lifetime prevalence rate, and 19% of adolescents report past-year illicit drug use with 7% meeting criteria for psychiatric disorder. Yet standard treatment quality for AEPs is considered mediocre to inadequate due to a host of factors headlined by the absence or modest quality of evidence-based services, insufficient provider training, and little quality monitoring.
Two behavioral treatment approaches are prime candidates for upgrading the quality of AEP treatment services. Both family therapy (FT) and cognitive-behavioral therapy (CBT) have excellent efficacy evidence for AEPs in both research and community settings. Each has strong support for treating serious conduct problems, delinquency, and substance use, and each has several manualized versions proven efficacious across the AEP range. Due to this extensive evidence base, there is incentive from clinical providers and payers to deliver these approaches in routine care: Both are now approved for treating AEPs by federal and private insurance plans and by regulatory agencies that govern licensed treatment providers. Notably, therapists report that both approaches are highly valued in everyday practice.
By consensus, the most efficient pathway toward improving the quality of mental health services is to increase the adoption and delivery of evidence-based interventions (EBIs) in usual care. However, there is a caveat: For EBIs to be effective in frontline settings, they must be delivered with sufficient fidelity to the principles and procedures of the approaches they represent. This remains a most difficult challenge for which innovative solutions are sorely needed. With regard to AEPs, controlled studies have shown that strong fidelity to the FT and CBT approaches predicts improved client outcomes in both efficacy and effectiveness studies. Yet, at this time, neither FT nor CBT are widely implemented with fidelity in community clinics that treat AEPs. To promote EBI fidelity as a core virtue of the behavioral care system, the study team published a theoretical model in which EBI implementation is recognized as an essential driver of positive client outcomes. This model includes structural characteristics of care that directly influence both implementation and outcomes, as well as outcomes considered relevant within the "quality of care" framework. The middle section depicts elements of implementation that have proven salient for effective EBI delivery, including technical factors (adherence to core treatment techniques, therapist competence) and relational factors (e.g., alliance), given that both are related to outcomes. According to this model and similar others, EBI implementation fidelity is a multidimensional construct with three primary facets: Adherence (extent to which signature EBI techniques are utilized), Competence (skillfulness and responsiveness of EBI delivery), and Alliance (working relationship between provider and client). In AEP research, fidelity-outcome studies consistently find that stronger EBI adherence and stronger alliance predict better client outcomes. Evidence for competence-outcome effects is less consistent, in large part because competence remains difficult to operationalize reliably. According to this framework, innovations aimed at improving service quality should directly target EBI fidelity; stronger EBI fidelity will then boost client outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTFS | Experimental | Behavioral: MTFS-I InstallationMTFS-I Installation |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Therapists treating adolescents aged 12-21 at partnering treatment sites
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| MTFS-I InstallationMTFS-I Installation will focus on introducing MTFS-I components including weekly training modules and mock video segments to be coded, as well as monthly feedback reports summarizing therapist self-reported FT and CBT implementation in active cases. Facilitation will also be included to review progress and provide regular support. | Behavioural | MTFS |
Primary outcome
Change in EBI Fidelity: ITT-ABP Therapist-Report
Time frame: Conclusion of every session for 1 year
Inventory of Therapy Techniques for Adolescent Behavior Problems is a 24-item, post-session, therapist-report fidelity tool that meets key criteria for pragmatic measures: relevance to stakeholders, low burden, broad applicability, strong psychometrics, and useful for data-driven decision-making (actionable). It requires 2-3 minutes to complete and was derived from validated observational fidelity tools for manualized treatments via a stakeholder-informed instrument adaptation process. The FT and CBT items each measure the adherence (i.e., thoroughness and frequency) with which each technique was used based on a 5-point Likert-type scale: 0 = Not at all, 1 = A little bit, 2 = Moderately, 3 = Considerably, 4 = Extensively.
1 secondary outcome
EBI Fidelity: ITT-ABP Observational Version
Time frame: Through study completion, approximately 1 year
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 31 Aug 2023.
- Derived from this study: PubMed 31822294Hogue A, Bobek M, MacLean A, Porter N, Jensen-Doss A, Henderson CE. Measurement training and feedback system for implementation of evidence-based treatment for adolescent externalizing problems: protocol for a randomized trial of pragmatic clinician training. Trials. 2019 Dec 10;20(1):700. doi: 10.1186/s13063-019-3783-8.
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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.
Aaron Hogue, PhD principal investigator
The Center on Addiction
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTFS-I Installation in people with Adolescent Behavior, run by The National Center on Addiction and Substance Abuse at Columbia University at 3 sites 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 1 inclusion and 1 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 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 in EBI Fidelity: ITT-ABP Therapist-Report (time frame: Conclusion of every session for 1 year). 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 NCT03722654, 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 31 Aug 2023.