Family Members
Conditions
Keywords
Coordinated Specialty Care, Family Engagement, First Episode Psychosis
Brief summary
Investigators aim to develop and evaluate a culturally informed family motivational engagement strategy (FAMES) and implementation toolkit for coordinated specialty care (CSC) programs for first episode psychosis. First, 5 family member participants will be recruited into a three-month trial of FAMES and implementation toolkit. The investigators will then conduct a 16-month non-randomized, stepped-wedge trial with 50 family members from 5 CSC programs in community-based mental health clinics.
Detailed description
FAMES involves three distinct and revolving components - early, continuous, and motivational contact - that incorporate motivational techniques and the Diagnostic and Statistical Manual of Mental Disorders 5TH Edition (DSM-5) Cultural Formulation Interview (CFI). The overarching objective of this study is to assess the feasibility and acceptability of a brief provider-led FAmily Engagement Motivational Strategy (FAMES) and its accompanying implementation toolkit. The investigators will also preliminary examine whether FAMES improves family engagement and retention in treatment, and motivation. A total of 50 participants with a loved one enrolled in CSC program for FEP will be recruited from five CSC programs in Washington State to take part in a non-randomized stepped-wedge pilot trial. Each CSC program will represent a cluster and serve as its own control. A two-month implementation transition period will occur at each CSC program and during which providers will be introduced to the intervention using the implementation toolkits and trained to conduct FAMES. A 12-month open cohort design will be utilized to recruit approximately 50 family members during the study period.
Interventions
BEHAVIORALFAMES
Participants will receive three distinct and revolving components - early, continuous, and motivational contact - that incorporate motivational techniques and the Diagnostic and Statistical Manual of Mental Disorders 5TH Edition (DSM-5) Cultural Formulation Interview (CFI).
BEHAVIORALTreatment-as-Usual
Participants will receive usual services and family-based treatment offered
Sponsors
National Institute of Mental Health (NIMH)
Washington State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older; 2. One family member (e.g., parent, guardian, aunt, uncle, spouse, grandparent, sibling, close friend) of an individual enrolled in a Washington State CSC program; and 3. Received no more than 6 months of services
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative interviews | Month 1 of treatment period and month 1 follow-up period; repeated measure to assess change in acceptability and feasibility | Interviews with providers and family member participants to assess acceptability and of FAMES |
| Client Satisfaction Questionnaire-8 (CSQ-8) | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion | Self-report measure to assess acceptability, a brief measure for family member participant. Items are scored from 1 to 4. Possible total scores range from 8 to 32, with higher scores (\>23) indicating greater satisfaction. |
| Youth Services Survey-Families (YSS-F) | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion | Self-report measure to assess acceptability in the following domains: appropriateness, participation, cultural sensitivity, social connectedness, and outcomes. Items in a domain are summed and divided by the total number of items, and scores greater than 3.5 are reported in the positive range for the domain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burden Assessment Scale (BAS) | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion | Self-report measure to assess family functioning. Total possible scores range from 10 to 171 (higher scores indicating greater burden) |
| Treatment Self-Regulation Questionnaire (TSRQ) | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion | Self-report measure to assess motivation. Scale ranges from 1=not at all true to 7=very true. |
| Iowa Cultural Understanding Assessment | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion | Self-report measure to assess provider cultural competence. All items are scored from 1=strongly disagree to 5=strongly agree. Total scores range from 25 to 125 (higher scores indicating great cultural competence) |
| Level of Engagement to measure effectiveness of FAMES | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion | Provider reported service utilization. Total number of contact hours between provider and family member to measure engagement |
| Rate of Retention to measure effectiveness of FAMES | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion | Provider reported service utilization. Percentage of families that dropout (family member declined or missed three consecutive appointments). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Organizational Readiness to Change Assessment (ORCA) | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion | Self-report provider measure to assess assess evidence assessment, contextual readiness and facilitation needs. All items are scored from 1=strongly disagree to 5=strongly agree |
Countries
United States
Outcome results
None listed