NCT03342872

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

August 3, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

October 30, 2017

Last Update Submit

August 2, 2021

Conditions

Keywords

AdolescentsSubstance Use Disorders

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

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

Interventions

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 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.

Core Training & Facilitation

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Therapists treating adolescents aged 12-21 at partnering treatment sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Outreach

Brentwood, New York, 11706, United States

Location

Horizon Health

Buffalo, New York, 14203, United States

Location

Related Publications (4)

  • 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.

  • Hogue 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.

  • Hogue 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.

  • Hogue 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Aaron Hogue, PhD

    The National Center on Addiction and Substance Abuse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 17, 2017

Study Start

April 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

August 3, 2021

Record last verified: 2021-01

Locations