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Project FACTS (Fidelity Accuracy: Comparing Three Strategies)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02820623
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : July 2, 2020
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Assess Fidelity to Cognitive-behavioral Therapy for Youth Behavioral: Self-report Behavioral: Chart-Stimulated Recall Behavioral: Behavioral Rehearsal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing Accuracy and Efficiency of Fidelity Measurement in CBT
Study Start Date : November 2016
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: 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.
Behavioral: Self-report
Experimental: 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.
Behavioral: Chart-Stimulated Recall
Experimental: 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.
Behavioral: Behavioral Rehearsal

Primary Outcome Measures :
  1. Total fidelity t-score of direct observation when compared to randomized fidelity method [ Time Frame: through study completion, an average of 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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., DHS is the guardian).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02820623

Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: Rinad S Beidas, PhD University of Pennsylvania
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Pennsylvania Identifier: NCT02820623    
Other Study ID Numbers: R01MH108551 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by University of Pennsylvania:
cognitive behavioral therapy