Clinical trial NCT02820623: Project FACTS (Fidelity Accuracy: Comparing Three Strategies)
Official title: Increasing Accuracy and Efficiency of Fidelity Measurement in CBT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assess Fidelity to Cognitive-behavioral Therapy for Youth
Keywords: implementation
fidelity
cognitive behavioral therapy
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2016-07-01
Enrollment: 126
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective is to compare the accuracy, costs, and cost-effectiveness of three fidelity measurement methods to assess fidelity to cognitive-behavioral therapy for youth. The investigators will randomize 135 therapists, implementing cognitive-behavioral therapy, to 3 conditions: self-report, chart stimulated recall, and behavioral rehearsal (N = 45 for each group). To calculate the outcomes of interest, each condition will be compared to the gold-standard fidelity measurement method, direct observation.

Detailed description: To achieve the primary objective, the investigators plan to (1) identify the most accurate fidelity measurement method; (2) estimate the economic costs and cost-effectiveness of the fidelity measurement methods; and (3) compare stakeholders' motivation to use each method, as well as identify their perceived barriers and facilitators to use of each method. This study will have a significant positive impact in two ways. First, it will validate fidelity measurement methods that can be used for research. Second, it will produce tools that can be used by community mental health clinics to monitor therapist fidelity, an indicator of therapy quality.

Eligibility criteria: Inclusion Criteria: Therapists

* they provide mental health treatment services in community mental health agencies in the City of Philadelphia participating in this study and

  * have been trained in cognitive-behavioral therapy (CBT) through the City-sponsored CBT evidence-based practice initiatives, and/or
  * respond to a brief screening survey that they use CBT; and/or
  * are nominated by a supervisor as a therapist who uses CBT.

Exclusion Criteria: Therapists

* n/a

Inclusion Criteria: Supervisors

* they are supervisors or administrators (i.e., they hold leadership positions) in community mental health agencies in the City of Philadelphia participating in this study.

Exclusion Criteria: Supervisors

* n/a

Inclusion Criteria: Youth and their Legal Guardians

* Youth and their legal guardians will be eligible to participate in this study if the youth

  * is 3-24 years old and
  * has completed at least one session with a therapist who has enrolled to participate in this study.

Exclusion Criteria: Youth and their Legal Guardians

* if the child does not have a legal guardian who is able to consent (e.g., the Department of Human Services (DHS) is the guardian).

Primary outcomes:
measure: Total Fidelity Scores for Each Study Condition Measured Via Direct Observation (TPOCS-RS) and Study Arm Fidelity Method Scores
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Rinad S Beidas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Emily M Becker-Haimes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Becker-Haimes EM, Marcus SC, Klein MR, Schoenwald SK, Fugo PB, McLeod BD, Dorsey S, Williams NJ, Mandell DS, Beidas RS. A Randomized Trial to Identify Accurate Measurement Methods for Adherence to Cognitive-Behavioral Therapy. Behav Ther. 2022 Nov;53(6):1191-1204. doi: 10.1016/j.beth.2022.06.001. Epub 2022 Jun 10.
citation: Beidas RS, Maclean JC, Fishman J, Dorsey S, Schoenwald SK, Mandell DS, Shea JA, McLeod BD, French MT, Hogue A, Adams DR, Lieberman A, Becker-Haimes EM, Marcus SC. A randomized trial to identify accurate and cost-effective fidelity measurement methods for cognitive-behavioral therapy: project FACTS study protocol. BMC Psychiatry. 2016 Sep 15;16(1):323. doi: 10.1186/s12888-016-1034-z.