Measurement Training and Feedback System: Family-Based Services

NCT03342872 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-08-03

No results posted yet for this study

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). 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.

Conditions

Interventions

BEHAVIORAL

Core Training: FBS System Mapping and MTFS-I Installation

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.

BEHAVIORAL

Core Training & Facilitation: FBS System Mapping and MTFS-I Installation plus monthly on-site meetings

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • The National Center on Addiction and Substance Abuse at Columbia University

    lead OTHER

Principal Investigators

  • Aaron Hogue, PhD · The National Center on Addiction and Substance Abuse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03342872 on ClinicalTrials.gov