Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K01MH117457-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAMES Modification | Experimental | 3-month trial of FAMES. Results from modifications will be used to by stakeholders (i.e., family members, client, providers, organizational leadership,) to inform finalization and implementation of FAMES |
|
| FAMES Pilot Trial | Experimental | Pilot testing of FAMES and implementation toolkit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAMES | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire-8 (CSQ-8) | 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. | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion |
| Youth Services Survey-Families (YSS-F) | 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. | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion |
| Qualitative interviews | Interviews with providers and family member participants to assess acceptability and of FAMES | Month 1 of treatment period and month 1 follow-up period; repeated measure to assess change in acceptability and feasibility |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Engagement to measure effectiveness of FAMES | Provider reported service utilization. Total number of contact hours between provider and family member to measure engagement | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion |
| Rate of Retention to measure effectiveness of FAMES |
| Measure | Description | Time Frame |
|---|---|---|
| Organizational Readiness to Change Assessment (ORCA) | 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 | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Journeys: Coordinated specialty care | Yakima | Washington | 98902 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32847910 | Derived | Oluwoye O, Dyck D, McPherson SM, Lewis-Fernandez R, Compton MT, McDonell MG, Cabassa LJ. Developing and implementing a culturally informed FAmily Motivational Engagement Strategy (FAMES) to increase family engagement in first episode psychosis programs: mixed methods pilot study protocol. BMJ Open. 2020 Aug 26;10(8):e036907. doi: 10.1136/bmjopen-2020-036907. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 18, 2026 | |
| Reset | Apr 6, 2026 | |
| Release | Jun 2, 2026 | |
| Reset | Jun 26, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 18, 2026 | Apr 6, 2026 | |||
| Jun 2, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Treatment-as-Usual | Behavioral | Participants will receive usual services and family-based treatment offered |
|
Provider reported service utilization. Percentage of families that dropout (family member declined or missed three consecutive appointments). |
| Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion |
| Burden Assessment Scale (BAS) | Self-report measure to assess family functioning. Total possible scores range from 10 to 171 (higher scores indicating greater burden) | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion |
| Iowa Cultural Understanding Assessment | 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) | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion |
| Treatment Self-Regulation Questionnaire (TSRQ) | Self-report measure to assess motivation. Scale ranges from 1=not at all true to 7=very true. | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion |
| Jun 26, 2026 |