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OpenTrials
Completed

NCT Number: NCT02820623

Project FACTS (Fidelity Accuracy: Comparing Three Strategies)

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.

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Key information

Conditions

Assess Fidelity to Cognitive-behavioral Therapy for Youth

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Self-report

Behavioral

Chart-Stimulated Recall

Behavioral

Behavioral Rehearsal

Behavioral

Primary outcomes

  1. Total Fidelity Scores for Each Study Condition Measured Via Direct Observation (TPOCS-RS) and Study Arm Fidelity Method Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study title

Increasing Accuracy and Efficiency of Fidelity Measurement in CBT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2016
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.