NCT03722654

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 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 24, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

October 24, 2018

Last Update Submit

August 29, 2023

Conditions

Keywords

AdolescentsConduct problemsDelinquencySubstance misuse

Outcome Measures

Primary Outcomes (1)

  • 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.

    Conclusion of every session for 1 year

Secondary Outcomes (1)

  • EBI Fidelity: ITT-ABP Observational Version

    Through study completion, approximately 1 year

Study Arms (2)

MTFS

EXPERIMENTAL

MTFS-I Installation

Behavioral: MTFS-I Installation

Control

NO INTERVENTION

Interventions

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.

MTFS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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 (3)

Roberto Clemente Center

New York, New York, 10009, United States

Location

The LGBT Community Center

New York, New York, 10011, United States

Location

Montefiore

New York, New York, 10461, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Aaron Hogue, PhD

    The Center on Addiction

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 29, 2018

Study Start

September 1, 2020

Primary Completion

June 1, 2022

Study Completion

June 30, 2022

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations