Table 4 Study assessments

Implementation outcomes

Fidelity

Providers, families, and participants

Adapted version of the OTNY fidelity scale. The scale assesses the degree to which FEP services deliver evidence-based practices. Fidelity assessment will be based on providers’ feedback, supervision calls, and site visits. Site visits have been established as a best practice for fidelity assessment [20].

6, 12, 24 months

NA

Acceptability

Providers

Providers’ attitudes to evidence-based practices will be measured by the Evidence-Based Practice Attitude Scale (EBPAS) [21]. The EBPAS consists of 15 items rated on a five-point scale from 0 (“Not at all”) to 4 (“Very great extent”). Range: 0–60 points.

Baseline, 12, 24 months

15 min

Uptake

Participants

The CollaboRATE [22] is a 3-item scale that measures Shared-Decision Making from users’ perspective. Each of the three items is rated on a scale of 0 (“no effort was made”) to 9 (“every effort was made”). Range: 0–27 points.

Baseline, 12, 24 months

5 min

Providers

The Shared Decision Making Questionnaire – Physician Version (SDM-Q-Doc) [23] will be employed to measure SDM at the provider level. This asks the clinician first to enter the health problem the consultation was about and which decision was made. The questionnaire continues with nine items about the steps in the SDM process, scoring at a six point scale that ranges from 0 (completely disagree) to 5 (completely agree). A total score can be calculated by summing the scores of all items. A high score indicates more SDM.

Baseline, 12, 24 months

10 min

Providers and participants

The Recovery Self-Assessment (RSA) [24] provider and patient versions is a 32-item, self-administered rating scale that focuses on perceptions of recovery principles and overall quality of services. It captures both providers’ and patients’ perceptions that a specific recovery-oriented intervention, in this case OTCH, is agreeable, palatable or satisfactory. Each item is rated on a 5-point scale (1 = Strongly Disagree; 5 = Strongly agree). Higher scores indicating greater quality care. Range: 32–160 points.

Baseline, 12, 24 months

15 min

Providers and partcipants

Ten ad-hoc questions regarding receipt of services that are central to OTCH including supported employment-education, family intervention/support, psychosocial interventions, and personal strenghts and resiliency training

Baseline, 12, 24 months

3 min

Service outcomes

Patient-centeredness

Participants

The Youth Services Survey (YSS) [25] is a scale that assesses perceptions about accessibility, quality, and impact of mental health service over a period of time. Only the first 15 items will be used in this study. Each item is rated on a 5-point scale from 1= “Strongly disagree” to 5 = “Strongly agree” (Range: 15–75 points).

Baseline, 12, 24 months

10 min

Medication adherence

Participants

Measured by the Brief Adherence Rating Scale (BARS) [26] It consists of 4 items: 3 questions and an overall visual analog rating scale to assess the percentage of antipsychotic medication doses taken by the user in the past month (0–100%).

Baseline, 12, 24 months

5 min

Retention

Participants

Time remaining in treatment will be estimated by counting the number of days between randomization to the time of the last mental health service received as defined by the RAISE-ETP report. The Service Utilization and Resources Form for Schizophrenia (SURF) [27] will be used to record users’ utilization of psychiatric and psychosocial rehabilitation services by conducting telephone contacts on a three-monthly basis. Range: from 0 to 365 days over a 12-month period; from 0 to 730 days over a 24-month period.

Every 3 months

15 min

Clinical outcomes

Psychotic symptoms

Participants

Positive and Negative Syndrome Scale (PANSS) [28] scale will be used to assess positive and negative symptoms (only the first 14 items). This scale includes seven rating points that represent increasing levels of psychopathology, from 1 (“absent”) to 7 (“extreme”). Range 7–49 points.

Baseline, 12, 24 months

20 min

Functioning

Participants

The Social and Role Functioning in Psychosis and Schizophrenia (SRFP) [29] scale asks for social, behavioral, and occupational difficulties associated with mental illness, including psychosis and schizophrenia. The scale rates functioning on a scale of 0 (“extreme role dysfunction”) to 10 (“superior social/interpersonal functioning”). Range: 7–70 points.

Baseline, 12, 24 months

20 min

Recovery orientation

Participants

The Questionnaire about the Process of Recovery (QPR) [30] assesses users’ perceptions about recovery from psychosis. It has 15 items each scored on a 4-point scale ranging from 0 (“strongly disagree”) to 4 (“strongly agree”). Higher scores on the measure are indicative of recovery (Range: 0–60 points).

Baseline, 12, 24 months

15 min

Moderators

Poverty

Community-level

Administrative data from the Chilean System of Social Protection [31] will be utilized to estimate percentage of the population living below the national poverty lines (0–100%).

As available across study period

N/A

Providers’ Attitudes to EBP

Providers

This will be measured by the Evidence-Based Practice Attitude Scale (EBPAS) [21] as described above under implementation outcomes.

Baseline

10 min

Providers’ Recovery orientation

Providers

The Recovery Self-Assessment (RSA) [24] as described above under implementation outcomes

Baseline

15 min

Symptoms

Participants

Measured by PANSS [28] as described above under clinical outcomes

Baseline

20 min

DUP

Participants

The time between the onset of psychotic symptoms and initiation of treatment at a mental health clinic based on the FEP registry.

Baseline

NA

Functioning

Participants

Measured by SRFP [29] as described above under clinical outcomes

Baseline

20 min

Socio-demographics

Participants

Age (15–19, 20–24, 25–29, 30–34, 35–40 years), gender (male, female), ethnicity, education, employment, and marital status

Baseline

10 min