Project FACTS (Fidelity Accuracy: Comparing Three Strategies)

Not Applicable

Completed

• Conditions: Assess Fidelity to Cognitive-behavioral Therapy for Youth
• Interventions: Behavioral: Behavioral Rehearsal; Behavioral: Self-report; Behavioral: Chart-Stimulated Recall

• Registration Number: NCT02820623
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-01
• Study Start: 2016-11
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Results First Submitted: 2022-08-18
• Results First Submitted QC: 2023-01-11
• Results First Posted: 2023-01-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Rehearsal	Behavioral Rehearsal	Therapists randomized to this condition will be asked to engage in role-plays demonstrating the CBT strategies used with the three enrolled youth. The investigators will provide therapists with a list of the TPOCS-S CBT strategies and ask them to identify the CBT strategies used in their recorded encounter. The investigators will randomly select one of the strategies they report for each role-play. The investigators will then tell them, "Please role-play how you used this strategy in session with your client, with the trained actor in front of you." Later, an independent rater will rate therapists' adherence and skill based on established scoring criteria.
Self-report	Self-report	Therapists randomized to this condition will complete a brief self-report measure, the Therapy Process Observational Coding System for Child Psychotherapy Strategies Scale-Self Report version (TPOCS-SR) for each of the recorded clinical encounters with enrolled youth. The TPOCS-SR will be a self-report version of the Therapy Process Observational Coding System for Child Psychotherapy-Strategies Scale (TPOCS-S) and will be created in collaboration with the instrument developer (McLeod). In this condition, the investigators will (a) provide an operational definition for each item on the TPOCS-SR (e.g., cognitive education: teaches client the cognitive model (e.g., thoughts influence behavior)/identifies how the cognitive model applies to a specific aspects of the client's life), and (b) provide therapists with a 30-minute training session that includes sample vignettes of particular behaviors and information about how those vignettes should be rated.
Chart Stimulated Recall	Chart-Stimulated Recall	Therapists randomized to this condition will be asked to bring the charts of three enrolled youth to the chart-stimulated recall interview. A trained interviewer will ask the therapists how well they recall the encounter (rating of memory quality) followed by an open-ended question ("Talk me through your last session with your client. Tell me what you did."). While the therapists are speaking, the interviewer will note any elements that represent a prescribed CBT strategy. The interviewer will go through a list of cognitive-behavioral strategies based upon the TPOCS-S and probe to determine if the therapists completed any of the strategies. Follow-up questions will be used to explore to what degree an element was used and how skillfully and responsively the strategies were used.

Primary Outcome Measures

Name	Time	Method
Total Fidelity Scores for Each Study Condition Measured Via Direct Observation (TPOCS-RS) and Study Arm Fidelity Method Scores	through study completion, an average of 1 month	Client sessions for all 3 conditions were scored for CBT adherence via direct observation using the Therapy Process Observational Coding System-Revised Strategies (TPOCS-RS) Scale (McLeod et al., 2015) on a 7-point Likert Scale (1='not at all,' 7='extensively'). We analyzed the TPOCS-RS' Maximum CBT score (highest coded intervention technique across all 12 possible interventions in a given session).; We also measured CBT adherence during client sessions using the strategies from each study condition (described in 'Arms/Groups' below). All 3 conditions used parallel 7-point scales to the TPOCS-RS.; Higher scores for the 3 study condition strategies indicate greater reported use, and higher scores on the TPOCS-RS indicate greater observed use of CBT interventions. Our goal was to compare the study condition methods of assessing CBT adherence to direct observation (TPOCS-RS), the gold standard.