Substance Use Disorders Clinical Trial
— MTFS-FBSOfficial 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. 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.
Status | Completed |
Enrollment | 84 |
Est. completion date | March 31, 2020 |
Est. primary completion date | March 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 21 Years |
Eligibility | Inclusion Criteria: - Therapists treating adolescents aged 12-21 at partnering treatment sites Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United States | Outreach | Brentwood | New York |
United States | Horizon Health | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
The National Center on Addiction and Substance Abuse at Columbia University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Once per month for 1 year | |
Primary | 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. | Conclusion of every session for 1 year | |
Primary | 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. | Baseline and 1-year follow-up |
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