Assess Fidelity to Cognitive-behavioral Therapy for Youth
Conditions
Keywords
implementation, fidelity, cognitive behavioral therapy
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.
Interventions
BEHAVIORALSelf-report
BEHAVIORALChart-Stimulated Recall
BEHAVIORALBehavioral Rehearsal
Sponsors
University of Pennsylvania
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Pre-assignment details
We enrolled 126 therapists in the study; these participants consented and were randomized to treatment. We assessed 304 therapists for enrollment in the study; of the therapists who were not enrolled, 86 did not meet inclusion criteria, 84 declined to participate, and 8 were excluded for other reasons.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Self-report | 41 |
| 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.
Chart-Stimulated Recall | 42 |
| 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 Rehearsal | 43 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Clients declined, piloting condition, or only telehealth | 0 | 0 | 3 |
| Overall Study | Participation interrupted due to COVID-19 | 3 | 3 | 2 |
| Overall Study | Therapist unable to enroll clients | 1 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 3 |
Baseline characteristics
| Characteristic | Chart Stimulated Recall | Total | Behavioral Rehearsal | Self-report |
|---|---|---|---|---|
| Age, Continuous | 37.42 years STANDARD_DEVIATION 12.13 | 37.33 years STANDARD_DEVIATION 12.66 | 34.76 years STANDARD_DEVIATION 11.76 | 39.93 years STANDARD_DEVIATION 13.81 |
| Education Bachelor's Degree | 2 Participants | 4 Participants | 2 Participants | 0 Participants |
| Education Doctorate | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Education Master's Degree | 37 Participants | 116 Participants | 39 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 12 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 110 Participants | 37 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 0 Participants | 2 Participants |
| Number of client sessions recorded in the study | 2.29 sessions STANDARD_DEVIATION 1.17 | 2.29 sessions STANDARD_DEVIATION 1.19 | 2.14 sessions STANDARD_DEVIATION 1.32 | 2.44 sessions STANDARD_DEVIATION 1.05 |
| Participated in city sponsored Evidence-Based Practice training initiative | 25 Participants | 82 Participants | 28 Participants | 29 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 22 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 12 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 32 Participants | 84 Participants | 29 Participants | 23 Participants |
| Region of Enrollment United States | 42 participants | 103 participants | 43 participants | 41 participants |
| Sex: Female, Male Female | 32 Participants | 94 Participants | 37 Participants | 25 Participants |
| Sex: Female, Male Male | 8 Participants | 28 Participants | 5 Participants | 15 Participants |
| Type of Employee Fee for service | 18 Participants | 54 Participants | 18 Participants | 18 Participants |
| Type of Employee No response | 4 Participants | 8 Participants | 3 Participants | 1 Participants |
| Type of Employee Salaried | 20 Participants | 64 Participants | 22 Participants | 22 Participants |
| Years Experience | 10.55 years STANDARD_DEVIATION 10.29 | 10.00 years STANDARD_DEVIATION 10.22 | 8.12 years STANDARD_DEVIATION 9.76 | 11.44 years STANDARD_DEVIATION 10.57 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 42 | 0 / 43 |
| other Total, other adverse events | 0 / 41 | 0 / 42 | 0 / 43 |
| serious Total, serious adverse events | 0 / 41 | 0 / 42 | 0 / 43 |
Outcome results
Primary
Total Fidelity Scores for Each Study Condition Measured Via Direct Observation (TPOCS-RS) and Study Arm Fidelity Method Scores
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.
Time frame: through study completion, an average of 1 month
Population: Participants (i.e., therapists) were assigned to one of 3 conditions: self-report, chart stimulated recall, or behavioral rehearsal. The unit of analysis for Maximum Mean condition score and Maximum Mean direct observation (TPOCS-RS) score was client session; therapists could include more than one client session for inclusion in analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self-report | Total Fidelity Scores for Each Study Condition Measured Via Direct Observation (TPOCS-RS) and Study Arm Fidelity Method Scores | Maximum Mean Condition Score | 5.28 Maximum CBT score on a scale | Standard Deviation 1.17 |
| Self-report | Total Fidelity Scores for Each Study Condition Measured Via Direct Observation (TPOCS-RS) and Study Arm Fidelity Method Scores | Maximum Mean direct observation (TPOCS-RS) Score | 3.42 Maximum CBT score on a scale | Standard Deviation 1.55 |
| Chart Stimulated Recall | Total Fidelity Scores for Each Study Condition Measured Via Direct Observation (TPOCS-RS) and Study Arm Fidelity Method Scores | Maximum Mean Condition Score | 4.53 Maximum CBT score on a scale | Standard Deviation 1.18 |
| Chart Stimulated Recall | Total Fidelity Scores for Each Study Condition Measured Via Direct Observation (TPOCS-RS) and Study Arm Fidelity Method Scores | Maximum Mean direct observation (TPOCS-RS) Score | 3.69 Maximum CBT score on a scale | Standard Deviation 1.36 |
| Behavioral Rehearsal | Total Fidelity Scores for Each Study Condition Measured Via Direct Observation (TPOCS-RS) and Study Arm Fidelity Method Scores | Maximum Mean Condition Score | 4.09 Maximum CBT score on a scale | Standard Deviation 1.48 |
| Behavioral Rehearsal | Total Fidelity Scores for Each Study Condition Measured Via Direct Observation (TPOCS-RS) and Study Arm Fidelity Method Scores | Maximum Mean direct observation (TPOCS-RS) Score | 3.72 Maximum CBT score on a scale | Standard Deviation 1.59 |