Substance Use DisordersMTFS-FBSNCT03342872
Measurement Training and Feedback System: Family-Based Services
A study testing Core Training: FBS System Mapping and MTFS-I Installation and Core Training & Facilitation: FBS System Mapping and MTFS-I Installation plus monthly on-site meetings in people with Substance Use Disorders, run by The National Center on Addiction and Substance Abuse at Columbia University at 2 sites in United States.
Trial summary
National mandates for increasing accountability in behavioral healthcare have created an urgent need for effective quality assurance (QA) procedures featuring pragmatic measures of treatment implementation quality in usual care (UC). Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Core Training: FBS System Mapping and MTFS-I Installation and Core Training & Facilitation: FBS System Mapping and MTFS-I Installation plus monthly on-site meetings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2019to 31 Mar 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Therapists treating adolescents aged 12-21 at partnering treatment sites
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Outreach
Brentwood, New York, 11706
Horizon Health
Buffalo, New York, 14203
About this study
Official title: Measurement Training and Feedback System for Implementation of Family-Based Services for Adolescent Substance Use: A Cluster Randomized Trial Protocol
National mandates for increasing accountability in behavioral healthcare have created an urgent need for effective quality assurance (QA) procedures featuring pragmatic measures of treatment implementation quality in usual care (UC). The most practical method for assessing treatment quality in UC is therapist self-report; unfortunately, therapist-report measures of fidelity to evidence-based practices (EBPs) have demonstrated weak validity to date. This study addresses this need for effective QA procedures by first developing treatment quality assurance procedures designed to increase the adoption and quality of empirically supported family-based services (FBS) for adolescent substance use (ASU) in usual care, and then testing two system-level implementation strategies for installing the new quality procedures in ASU treatment sites.
FBS have achieved the strongest evidence base for treating ASU and are a prime candidate for upgrading the quality of ASU services in various systems of care. FBS comprise both family participation in services, the systemic parameters wherein family members are included in assessment and treatment activities; and family therapy techniques, the specific interventions that clinicians use to directly target family members and family functioning for change. For FBS to fulfill their potential to enhance ASU treatment systems, FBS implementation must be supported by effective quality assurance procedures designed to ensure that FBS are delivered with fidelity. The proposed study will leverage a strong research-government partnership between the applicant organization and the New York single-state agency for SU services.
Read more
The study will first develop innovative quality procedures (Aim 1) that use existing FBS quality metrics to promote high-fidelity FBS: Measurement Training and Feedback System for Implementation (MTFS-I), a pragmatic evidence-based method for increasing FBS quality by providing monthly feedback on therapist-reported FBS delivery along with brief online FBS training modules. The study will then experimentally compare two system-level implementation strategies designed to foster MTFS-I utilization in usual care for ASU. Core Training Only will contain two 3-hour training sessions: Mapping existing FBS and identifying site goals for FBS improvement; and Installing and sustaining the MTFS-I. Core + Facilitation is an additive strategy that will begin with the Core Training sessions and then continue with monthly facilitation meetings for one year to promote MTFS-I use and progress toward FBS improvement.
The study will feature a three-group cluster randomized trial testing Core Training Only versus Core + Facilitation versus no-intervention Control in 9 ASU clinics across New York State. MTFS-I utilization data will be collected from Core Training and Core + Facilitation sites for one-year follow-up (after initial Core Training); FBS quality data on family participation and family therapy technique use will be collected from all sites over one-year follow-up; observational coding methods will verify therapist reports of FBS quality; and client outcome data for all sites will be retrieved from administrative data warehouses over one-year baseline and one-year follow-up. These data will enable between-condition comparisons of FBS delivery (Aim 2: MTFS-I utilization, family participation, family therapy technique use) and client outcomes (Aim 3: therapeutic goal achievement, substance use change). If study aims are achieved, investigators would be positioned to mount a fully powered RCT to test the effectiveness of these FBS quality improvement procedures at scale.
Read the detailed description
Discovering and disseminating effective methods to improve the quality of treatment services for adolescent substance use (ASU) within the national behavioral healthcare system is an urgent public health priority. Despite the strong legislative and policy focus on quality of care evident in the Children's Health Insurance Program Reauthorization Act of 2009 and the Affordable Care Act of 2010, recent comprehensive reports underscore the enduring "quality chasm" between behavioral treatments proven in controlled research versus those commonly practiced in usual care. ASU treatment quality in particular is considered mediocre to inadequate, due to a host of factors headlined by the absence or modest quality of evidence-based services, along with inadequate provider training, little quality monitoring, inattention to data-driven decision-making, and ineffective system-level policies for promoting existing quality mandates.
Family-based services (FBS) are a prime candidate for upgrading the quality of the ASU treatment system. FBS comprise both family participation in services, the systemic parameters wherein family members are included in assessment and treatment activities; and family therapy techniques, the specific interventions that clinicians use to directly target family members and family functioning for change. FBS have reached the highest levels of empirical validation for ASU, posting an exemplary record of success in comparison to alternative evidence-based treatments as well as usual care, and FBS produce the largest average effect sizes by a large margin. Due in large part to this extensive evidence base, FBS have long been strongly endorsed by federal agencies, national associations, and policy-making groups. There is also incentive from ASU clinical providers and payers to deliver FBS, which are now approved for treating ASU and disruptive behavior disorders by federal and private insurance plans and regulatory agencies that govern licensed treatment providers. FBS are also widely endorsed by therapists treating youth in routine care. Thus there is impetus from all corners to expand FBS implementation in usual care for ASU.
There are several well-documented barriers to dissemination of manualized FBS models, including the cost and complexity of delivering these models in everyday settings. In addition, for FBS to fulfill their potential to enhance the quality of ASU treatment in usual care, FBS implementation must be supported by effective quality assurance (QA) procedures designed to ensure that FBS are delivered with fidelity, that is, to the target population, by appropriately trained providers, and in accord with specified procedures. The time is propitious for developing such procedures in the current healthcare market, which is incentivized to establish reliable standards for quality care. First, there is growing demand for innovative quality indicators of behavioral treatment that assess appropriateness and potential effectiveness of care. Conventional quality indicators capture broad principles of behavioral care such as treatment assignment, retention and follow-up rates, referrals for ancillary care, and client safety. However, the emerging quality-of-care implementation framework advocates that fidelity to evidence-based treatments itself be considered a quality indicator. Second, in order to properly monitor treatment fidelity in usual care, there is urgent need to develop quality metrics that can reliably and pragmatically measure fidelity in front-line treatment settings. The implications of emerging scientific and policy mandates for improving treatment quality are clear with regard to FBS for ASU: Pragmatic QA procedures for ensuring high-fidelity FBS need to be developed, and these procedures need to be anchored by reliable FBS fidelity metrics.
This study will develop pragmatic QA procedures designed to promote FBS adoption and quality in ASU treatment systems using a measurement feedback system (MFS). MFS is a performance feedback loop in which a given quality indicator is continuously monitored by the clinician to gauge case progress and support clinical decision-making. MFS feedback loops usually take the form of easy-to-digest data reports that provide summary appraisals of individual client progress on selected indicators in comparison to a desired benchmark. To date MFS has been used in mental health care to enable monitoring of client outcomes primarily-for example, therapists tracking weekly client-report depression scores compared to age-adjusted norms on a depression inventory. With adults, utilizing MFS has led to impressive gains in outcomes with diverse samples: preventing early treatment failure, reversing symptom deterioration, and enhancing overall outcomes. MFS research on youth is in its early stages but growing rapidly, with strong enthusiasm about reaping comparable benefits. Importantly, clinicians trained in MFS develop positive attitudes toward it.
MFS successes for client outcomes have generated enthusiastic support for the value of developing complementary MFS procedures that provide measurement Training along with data-based Feedback on implementation: MTFS-I. Due to streamlined administration procedures and emerging evidence, MTFS-I has been labeled a promising QA strategy with broad dissemination potential for youth. MTFS-I has already been incorporated into manualized QA procedures to bolster fidelity to several varieties of manualized treatment; in a few of these instances, feedback reports contain data input from therapists on fidelity indicators. One study found that MTFS-I for clinician-reported session content during youth therapy increased the likelihood and rapidity of addressing that same content in future sessions. In keeping with primary goals of the R34 mechanism, this study will test a pragmatic MTFS-I designed to improve the quality of FBS implementation in ASU treatment sites. The MTFS-I will draw on technology from existing feedback systems, but also, be the first to target system-level FBS delivery for ASU. The four MTFS-I components, described in C4, are designed to increase the extensiveness (i.e., amount and frequency of) FBS implementation.
- Conditions
- Substance Use Disorders
- Being tested
- Core Training: FBS System Mapping and MTFS-I Installation, Core Training & Facilitation: FBS System Mapping and MTFS-I Installation plus monthly on-site meetings
- Keywords
- Adolescents, Substance Use Disorders
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Training: FBS System Mapping and MTFS-I InstallationBehavioural
Core Training will be a blended strategy wherein multiple interventions targeting multiple agency roles are combined to help ASU treatment providers increase their FBS quality. Core Training will be conducted with administrators, supervisors, data managers, and clinical staff. It will contain two 3-hour sessions focusing on FBS System Mapping and MTFS-I Installation. FBS System Mapping will focus on process mapping of existing site policies and practices for assessing family functioning at intake, educating families about intervention strategies and activities, including family members in treatment sessions, and hiring and supporting clinicians trained in and routinely delivering FBS. MTFS-Installation will focus on introducing MTFS-I components and integrating principles of DDDM.
Core Training & Facilitation: FBS System Mapping and MTFS-I Installation plus monthly on-site meetingsBehavioural
Facilitation will consist of monthly on-site meetings to review progress toward FBS improvements, discuss MTFS-I feedback reports and online resource use, and provide intensive technical assistance for progressing toward site-selected FBS improvement goals. Meetings will involve a subset of site-delegated participants from Core Training sessions to serve as a local change team (quality improvement team). The efficacy of facilitation-guided change teams has been established. Although there are several models for creating change teams, at least three features are common: (1) members represent multiple organizational roles (supervisors, data managers, line staff); (2) focus on data-driven decisions; and (3) use of external expert advisors.
| Study group | Role | What they receive |
|---|---|---|
| Core Training | Experimental | Not described Receives: Behavioral: Core Training: FBS System Mapping and MTFS-I Installation |
| Core Training & Facilitation | Experimental | Not described Receives: Behavioral: Core Training & Facilitation: FBS System Mapping and MTFS-I Installation plus monthly on-site meetings |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Family Participation
The Clinical Practice Standards for Adolescent Programs (CPS-AP) is a manualized set of ASU service delivery guidelines co-developed by OASAS and CASA. The Manual describes each of 12 Standards using the following format: (a) theoretical background illustrating the clinical and programmatic salience of the Standard for delivering quality ASU treatment; (b) 4-8 main components of the given Standard, with a cross-Standard focus on developmental science-based differences between adolescent versus adult treatment practices; (c) brief clinical descriptions and exemplars of each Standard. Throughout the study therapists will be asked to complete a web-based form to report on family participation via the CPS-AP (once per month).
Measured: Once per month for 1 year
Change in Family Therapy Techniques
The proposed study will utilize the 7-item Family Therapy (FT) scale from the 27-item Inventory of Therapy Techniques for Adolescent Behavior Problems (ITT-ABP). The ITT-ABP is a QA tool designed to collect post-session therapist-report data on implementation of four treatment approaches commonly deployed in front-line ASU care: FT, cognitive-behavioral therapy (CBT), motivational interviewing (MI), and drug counseling (DC). The ITT-ABP observational version mirrors the therapist-report version, containing the same 7 FT scale items. We will collect session audio recordings with all study families, and from among all recordings we will randomly select one session from the Early and Later phase of each case for coding with the observer version of the ITT-ABP.
Measured: Conclusion of every session for 1 year
Change in Treatment Goals and Reduction in Substance Use
Client outcomes will be extracted from the OASAS Client Data System. For analyses, we will extract non-identified data on all clients admitted to the 9 study sites during the one-year Baseline and FU periods. The categories to be analyzed under Outcome 3 are achievement of therapeutic goals and reduction of substance use. Treatment goal achievement is rated on a 3-point scale (1 = achieved; 2 = partially achieved; 3 = not achieved) for the following categories as applicable to a given client: Overall program goals; Alcohol use; Drug use; Education/Vocation; Social functioning; Emotional functioning; Family situation; Medical. To rate client change in SU during the course of treatment, therapists confer with clients and compare SU during the 30 days prior to discharge with SU reported at admission for up to three substances on the following scale: 1 = abstinence achieved; 2 = reduced usage; 3 = no change; 4 = increased usage; 5 = unknown usage.
Measured: Baseline and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Apr 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance Use 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a cluster randomized trial testing two additive implementation strategies for installing FBS quality improvement procedures in ASU outpatient treatment. Nine ASU treatment sites will be yoked and randomized into three conditions to enhance ecological validity; 1) Core Training Only; 2) Core Training and Facilitation; and 3) Control (no intervention). The implementation strategies (i.e., Core Training Only, Core + Facilitation), are system-level strategies for translating evidence-based interventions into multi-site service settings.
- Masking
- None (open label)
- Enrolment
- 84 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 on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Aaron Hogue, PhD, Principal investigator, The National Center on Addiction and Substance Abuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342872
- Sponsor's protocol ID
- 1R34DA044740-01
- Other IDs
- R34DA044740
- Acronym
- MTFS-FBS
- Status last verified
- Jan 2021
- First submitted
- 30 Oct 2017
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hogue A, MacLean A, Bobek M, Porter N, Bruynesteyn L, Jensen-Doss A, Henderson CE. Pilot Trial of Online Measurement Training and Feedback in Family Therapy for Adolescent Behavior Problems. J Clin Child Adolesc Psychol. 2023 Nov-Dec;52(6):850-865. doi: 10.1080/15374416.2022.2051529. Epub 2022 Apr 6.
PubMed 35384750Hogue A, Bobek M, Porter N, MacLean A, Bruynesteyn L, Jensen-Doss A, Henderson CE. Therapist Self-Report of Fidelity to Core Elements of Family Therapy for Adolescent Behavior Problems: Psychometrics of a Pragmatic Quality Indicator Tool. Adm Policy Ment Health. 2022 Mar;49(2):298-311. doi: 10.1007/s10488-021-01164-0. Epub 2021 Sep 2.
PubMed 34476623Hogue A, Porter N, Bobek M, MacLean A, Bruynesteyn L, Jensen-Doss A, Dauber S, Henderson CE. Online Training of Community Therapists in Observational Coding of Family Therapy Techniques: Reliability and Accuracy. Adm Policy Ment Health. 2022 Jan;49(1):139-151. doi: 10.1007/s10488-021-01152-4. Epub 2021 Jul 23.
PubMed 34297259Hogue A, Dauber S, Bobek M, Jensen-Doss A, Henderson CE. Measurement Training and Feedback System for Implementation of family-based services for adolescent substance use: protocol for a cluster randomized trial of two implementation strategies. Implement Sci. 2019 Mar 11;14(1):25. doi: 10.1186/s13012-019-0874-6.
PubMed 30866967
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement Training and Feedback System for Implementation of Family-Based Services for Adolescent Substance Use: A Cluster Randomized Trial Protocol
- ClinicalTrials.gov ID
- NCT03342872
- Acronym / sponsor ID
- MTFS-FBS / 1R34DA044740-01
- Conditions
- Substance Use Disorders
- Keywords
- Adolescents, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 17 Nov 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.
National mandates for increasing accountability in behavioral healthcare have created an urgent need for effective quality assurance (QA) procedures featuring pragmatic measures of treatment implementation quality in usual care (UC). The most practical method for assessing treatment quality in UC is therapist self-report; unfortunately, therapist-report measures of fidelity to evidence-based practices (EBPs) have demonstrated weak validity to date. This study addresses this need for effective QA procedures by first developing treatment quality assurance procedures designed to increase the adoption and quality of empirically supported family-based services (FBS) for adolescent substance use (ASU) in usual care, and then testing two system-level implementation strategies for installing the new quality procedures in ASU treatment sites.
FBS have achieved the strongest evidence base for treating ASU and are a prime candidate for upgrading the quality of ASU services in various systems of care. FBS comprise both family participation in services, the systemic parameters wherein family members are included in assessment and treatment activities; and family therapy techniques, the specific interventions that clinicians use to directly target family members and family functioning for change. For FBS to fulfill their potential to enhance ASU treatment systems, FBS implementation must be supported by effective quality assurance procedures designed to ensure that FBS are delivered with fidelity. The proposed study will leverage a strong research-government partnership between the applicant organization and the New York single-state agency for SU services.
The study will first develop innovative quality procedures (Aim 1) that use existing FBS quality metrics to promote high-fidelity FBS: Measurement Training and Feedback System for Implementation (MTFS-I), a pragmatic evidence-based method for increasing FBS quality by providing monthly feedback on therapist-reported FBS delivery along with brief online FBS training modules. The study will then experimentally compare two system-level implementation strategies designed to foster MTFS-I utilization in usual care for ASU. Core Training Only will contain two 3-hour training sessions: Mapping existing FBS and identifying site goals for FBS improvement; and Installing and sustaining the MTFS-I. Core + Facilitation is an additive strategy that will begin with the Core Training sessions and then continue with monthly facilitation meetings for one year to promote MTFS-I use and progress toward FBS improvement.
The study will feature a three-group cluster randomized trial testing Core Training Only versus Core + Facilitation versus no-intervention Control in 9 ASU clinics across New York State. MTFS-I utilization data will be collected from Core Training and Core + Facilitation sites for one-year follow-up (after initial Core Training); FBS quality data on family participation and family therapy technique use will be collected from all sites over one-year follow-up; observational coding methods will verify therapist reports of FBS quality; and client outcome data for all sites will be retrieved from administrative data warehouses over one-year baseline and one-year follow-up. These data will enable between-condition comparisons of FBS delivery (Aim 2: MTFS-I utilization, family participation, family therapy technique use) and client outcomes (Aim 3: therapeutic goal achievement, substance use change). If study aims are achieved, investigators would be positioned to mount a fully powered RCT to test the effectiveness of these FBS quality improvement procedures at scale.
Detailed description
Discovering and disseminating effective methods to improve the quality of treatment services for adolescent substance use (ASU) within the national behavioral healthcare system is an urgent public health priority. Despite the strong legislative and policy focus on quality of care evident in the Children's Health Insurance Program Reauthorization Act of 2009 and the Affordable Care Act of 2010, recent comprehensive reports underscore the enduring "quality chasm" between behavioral treatments proven in controlled research versus those commonly practiced in usual care. ASU treatment quality in particular is considered mediocre to inadequate, due to a host of factors headlined by the absence or modest quality of evidence-based services, along with inadequate provider training, little quality monitoring, inattention to data-driven decision-making, and ineffective system-level policies for promoting existing quality mandates.
Family-based services (FBS) are a prime candidate for upgrading the quality of the ASU treatment system. FBS comprise both family participation in services, the systemic parameters wherein family members are included in assessment and treatment activities; and family therapy techniques, the specific interventions that clinicians use to directly target family members and family functioning for change. FBS have reached the highest levels of empirical validation for ASU, posting an exemplary record of success in comparison to alternative evidence-based treatments as well as usual care, and FBS produce the largest average effect sizes by a large margin. Due in large part to this extensive evidence base, FBS have long been strongly endorsed by federal agencies, national associations, and policy-making groups. There is also incentive from ASU clinical providers and payers to deliver FBS, which are now approved for treating ASU and disruptive behavior disorders by federal and private insurance plans and regulatory agencies that govern licensed treatment providers. FBS are also widely endorsed by therapists treating youth in routine care. Thus there is impetus from all corners to expand FBS implementation in usual care for ASU.
There are several well-documented barriers to dissemination of manualized FBS models, including the cost and complexity of delivering these models in everyday settings. In addition, for FBS to fulfill their potential to enhance the quality of ASU treatment in usual care, FBS implementation must be supported by effective quality assurance (QA) procedures designed to ensure that FBS are delivered with fidelity, that is, to the target population, by appropriately trained providers, and in accord with specified procedures. The time is propitious for developing such procedures in the current healthcare market, which is incentivized to establish reliable standards for quality care. First, there is growing demand for innovative quality indicators of behavioral treatment that assess appropriateness and potential effectiveness of care. Conventional quality indicators capture broad principles of behavioral care such as treatment assignment, retention and follow-up rates, referrals for ancillary care, and client safety. However, the emerging quality-of-care implementation framework advocates that fidelity to evidence-based treatments itself be considered a quality indicator. Second, in order to properly monitor treatment fidelity in usual care, there is urgent need to develop quality metrics that can reliably and pragmatically measure fidelity in front-line treatment settings. The implications of emerging scientific and policy mandates for improving treatment quality are clear with regard to FBS for ASU: Pragmatic QA procedures for ensuring high-fidelity FBS need to be developed, and these procedures need to be anchored by reliable FBS fidelity metrics.
This study will develop pragmatic QA procedures designed to promote FBS adoption and quality in ASU treatment systems using a measurement feedback system (MFS). MFS is a performance feedback loop in which a given quality indicator is continuously monitored by the clinician to gauge case progress and support clinical decision-making. MFS feedback loops usually take the form of easy-to-digest data reports that provide summary appraisals of individual client progress on selected indicators in comparison to a desired benchmark. To date MFS has been used in mental health care to enable monitoring of client outcomes primarily-for example, therapists tracking weekly client-report depression scores compared to age-adjusted norms on a depression inventory. With adults, utilizing MFS has led to impressive gains in outcomes with diverse samples: preventing early treatment failure, reversing symptom deterioration, and enhancing overall outcomes. MFS research on youth is in its early stages but growing rapidly, with strong enthusiasm about reaping comparable benefits. Importantly, clinicians trained in MFS develop positive attitudes toward it.
MFS successes for client outcomes have generated enthusiastic support for the value of developing complementary MFS procedures that provide measurement Training along with data-based Feedback on implementation: MTFS-I. Due to streamlined administration procedures and emerging evidence, MTFS-I has been labeled a promising QA strategy with broad dissemination potential for youth. MTFS-I has already been incorporated into manualized QA procedures to bolster fidelity to several varieties of manualized treatment; in a few of these instances, feedback reports contain data input from therapists on fidelity indicators. One study found that MTFS-I for clinician-reported session content during youth therapy increased the likelihood and rapidity of addressing that same content in future sessions. In keeping with primary goals of the R34 mechanism, this study will test a pragmatic MTFS-I designed to improve the quality of FBS implementation in ASU treatment sites. The MTFS-I will draw on technology from existing feedback systems, but also, be the first to target system-level FBS delivery for ASU. The four MTFS-I components, described in C4, are designed to increase the extensiveness (i.e., amount and frequency of) FBS implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a cluster randomized trial testing two additive implementation strategies for installing FBS quality improvement procedures in ASU outpatient treatment. Nine ASU treatment sites will be yoked and randomized into three conditions to enhance ecological validity; 1) Core Training Only; 2) Core Training and Facilitation; and 3) Control (no intervention). The implementation strategies (i.e., Core Training Only, Core + Facilitation), are system-level strategies for translating evidence-based interventions into multi-site service settings.
| Arm | Type | Receives |
|---|---|---|
| Core Training | Experimental | Behavioral: Core Training: FBS System Mapping and MTFS-I Installation |
| Core Training & Facilitation | Experimental | Behavioral: Core Training & Facilitation: FBS System Mapping and MTFS-I Installation plus monthly on-site meetings |
| Control | No intervention | – |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| Core Training: FBS System Mapping and MTFS-I InstallationCore Training will be a blended strategy wherein multiple interventions targeting multiple agency roles are combined to help ASU treatment providers increase their FBS quality. Core Training will be conducted with administrators, supervisors, data managers, and clinical staff. It will contain two 3-hour sessions focusing on FBS System Mapping and MTFS-I Installation. FBS System Mapping will focus on process mapping of existing site policies and practices for assessing family functioning at intake, educating families about intervention strategies and activities, including family members in treatment sessions, and hiring and supporting clinicians trained in and routinely delivering FBS. MTFS-Installation will focus on introducing MTFS-I components and integrating principles of DDDM. | Behavioural | Core Training |
| Core Training & Facilitation: FBS System Mapping and MTFS-I Installation plus monthly on-site meetingsFacilitation will consist of monthly on-site meetings to review progress toward FBS improvements, discuss MTFS-I feedback reports and online resource use, and provide intensive technical assistance for progressing toward site-selected FBS improvement goals. Meetings will involve a subset of site-delegated participants from Core Training sessions to serve as a local change team (quality improvement team). The efficacy of facilitation-guided change teams has been established. Although there are several models for creating change teams, at least three features are common: (1) members represent multiple organizational roles (supervisors, data managers, line staff); (2) focus on data-driven decisions; and (3) use of external expert advisors. | Behavioural | Core Training & Facilitation |
Primary outcome
Change in Family Participation
Time frame: Once per month for 1 year
The Clinical Practice Standards for Adolescent Programs (CPS-AP) is a manualized set of ASU service delivery guidelines co-developed by OASAS and CASA. The Manual describes each of 12 Standards using the following format: (a) theoretical background illustrating the clinical and programmatic salience of the Standard for delivering quality ASU treatment; (b) 4-8 main components of the given Standard, with a cross-Standard focus on developmental science-based differences between adolescent versus adult treatment practices; (c) brief clinical descriptions and exemplars of each Standard. Throughout the study therapists will be asked to complete a web-based form to report on family participation via the CPS-AP (once per month).
Change in Family Therapy Techniques
Time frame: Conclusion of every session for 1 year
The proposed study will utilize the 7-item Family Therapy (FT) scale from the 27-item Inventory of Therapy Techniques for Adolescent Behavior Problems (ITT-ABP). The ITT-ABP is a QA tool designed to collect post-session therapist-report data on implementation of four treatment approaches commonly deployed in front-line ASU care: FT, cognitive-behavioral therapy (CBT), motivational interviewing (MI), and drug counseling (DC). The ITT-ABP observational version mirrors the therapist-report version, containing the same 7 FT scale items. We will collect session audio recordings with all study families, and from among all recordings we will randomly select one session from the Early and Later phase of each case for coding with the observer version of the ITT-ABP.
Change in Treatment Goals and Reduction in Substance Use
Time frame: Baseline and 1-year follow-up
Client outcomes will be extracted from the OASAS Client Data System. For analyses, we will extract non-identified data on all clients admitted to the 9 study sites during the one-year Baseline and FU periods. The categories to be analyzed under Outcome 3 are achievement of therapeutic goals and reduction of substance use. Treatment goal achievement is rated on a 3-point scale (1 = achieved; 2 = partially achieved; 3 = not achieved) for the following categories as applicable to a given client: Overall program goals; Alcohol use; Drug use; Education/Vocation; Social functioning; Emotional functioning; Family situation; Medical. To rate client change in SU during the course of treatment, therapists confer with clients and compare SU during the 30 days prior to discharge with SU reported at admission for up to three substances on the following scale: 1 = abstinence achieved; 2 = reduced usage; 3 = no change; 4 = increased usage; 5 = unknown usage.
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 3 Aug 2021.
- Derived from this study: PubMed 35384750Hogue A, MacLean A, Bobek M, Porter N, Bruynesteyn L, Jensen-Doss A, Henderson CE. Pilot Trial of Online Measurement Training and Feedback in Family Therapy for Adolescent Behavior Problems. J Clin Child Adolesc Psychol. 2023 Nov-Dec;52(6):850-865. doi: 10.1080/15374416.2022.2051529. Epub 2022 Apr 6.
- Derived from this study: PubMed 34476623Hogue A, Bobek M, Porter N, MacLean A, Bruynesteyn L, Jensen-Doss A, Henderson CE. Therapist Self-Report of Fidelity to Core Elements of Family Therapy for Adolescent Behavior Problems: Psychometrics of a Pragmatic Quality Indicator Tool. Adm Policy Ment Health. 2022 Mar;49(2):298-311. doi: 10.1007/s10488-021-01164-0. Epub 2021 Sep 2.
- Derived from this study: PubMed 34297259Hogue A, Porter N, Bobek M, MacLean A, Bruynesteyn L, Jensen-Doss A, Dauber S, Henderson CE. Online Training of Community Therapists in Observational Coding of Family Therapy Techniques: Reliability and Accuracy. Adm Policy Ment Health. 2022 Jan;49(1):139-151. doi: 10.1007/s10488-021-01152-4. Epub 2021 Jul 23.
- Derived from this study: PubMed 30866967Hogue A, Dauber S, Bobek M, Jensen-Doss A, Henderson CE. Measurement Training and Feedback System for Implementation of family-based services for adolescent substance use: protocol for a cluster randomized trial of two implementation strategies. Implement Sci. 2019 Mar 11;14(1):25. doi: 10.1186/s13012-019-0874-6.
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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 National Center on Addiction and Substance Abuse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Training: FBS System Mapping and MTFS-I Installation and Core Training & Facilitation: FBS System Mapping and MTFS-I Installation plus monthly on-site meetings in people with Substance Use Disorders, run by The National Center on Addiction and Substance Abuse at Columbia University at 2 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Family Participation (time frame: Once per month for 1 year). The study lists 3 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 NCT03342872, which also lists 4 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 3 Aug 2021.