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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH136132 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Family members/support persons' engagement in mental health services has been linked to reduced burden and stress and improves engagement and outcomes in individuals in the early stages of psychosis. The goal of FAMES is to address low family member/support person engagement in services. FAMES will also address disparities in coordinated specialty care (CSC) by using a culturally responsive family engagement strategy to be delivered by family peers.
The overall goal of this mixed-methods, clustered stepped-wedged designed study is to examine the effectiveness of a family peer implemented in coordinated specialty care programs at engaging family members in services. The use of a family peer is anticipated to increase family member participant's feelings of connectedness, self-efficacy, and motivation which will in turn improve family member participants engagement in scheduled coordinated specialty care services such as family psychoeducation.
Recruitment will consist of dyads compromised of a family member support person and a corresponding individual receiving coordinated specialty care services. Recruitment will occur over two waves, the attention control condition (ACC) and the FAMES condition. The ACC will last for 18 months and will recruit 225 participant dyads during which time family member participants will be contacted weekly for 12 weeks where they will be provided with positively framed messaging, educational materials around psychosis, tips for addressing relevant concerns in areas such as communication and de-escalation, and a list of community-based and online resources and events. The FAMES condition will last for 30 months and will recruit 225 participant dyads during which time family member participants will receive a modified cultural formulation interview, brief check-ins, psychoeducation, and will have access to an online community.
Recruitment will take place at nine coordinated specialty care programs across four states (Washington, Oregon, Tennessee, and New Mexico) which have been randomized to a clustered stepped wedge program design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Control Condition | Active Comparator | 225 dyads (family members/support persons and individuals receiving services for psychosis) will be recruited over a period of 18 months to receive 12 weeks of weekly communication via text, email or phone call, which includes positive messaging, community resources, appointment reminders, and psychoeducation. |
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| Active Condition | Active Comparator | This arm lasts for 30 months during each wave of the clustered randomized stepped wedge design. 225 participants will receive the FAMES intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAMES | Behavioral | 225 dyads (family member/support persons and individuals receiving services for psychosis) will be recruited over a period of 30 months. Family member/support persons will be connected to a family peer for a period of 12 weeks who will use the cultural formulated interview to develop rapport and identify unique cultural needs which can inform treatment and resource identification. Participants will receive brief contact, family psychoeducation, and be connected to an online family resource group where they can receive additional support from certified peers and other family member/support persons. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement in coordinated specialty care psychoeducation | Will be measured as first session attendance rate and total attendance rate per family provided by administrative data from the coordinated specialty care site partners. | Baseline through study completion; repeated measure to assess change through study completion, average of 3 months |
| Engagement in Family Engagement Strategy | Total number of Family Engagement Strategy session attended and the total number of contact minutes to measure engagement. | Baseline through study completion; repeated measure to assess change through study completion, average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale | A self-report measure which includes 10 Likert-style items to assess the degree to which an individual appraises life as stressful. Scores range from 0-40 where scores greater that 13 indicate moderate to high perceived stress. | Baseline through study completion; repeated measure to assess change through study completion, average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| General Self-Efficacy Scale | A self-report 10-item measure completed by the family member participant. Scores range from 10-40 with higher scores indicating greater self-efficacy. | Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months |
| Social Connectedness subscale of the Youth Services Survey - Families |
Family Member / Support Person Inclusion Criteria:
Exclusion Criteria:
Primary Service User Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oladunni Oluwoye, Associate Professor, Ph.D. | Contact | 509-368-6805 | oladunni.oluwoye@wsu.edu | |
| Bryony Stokes, Program Manager, M.S. | Contact | 509-505-7001 | bryony.mueller@wsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deschutes County Behavioral Health EASA | Not yet recruiting | Bend | Oregon | 97703 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41402877 | Derived | Oluwoye O, Stokes B, Crisanti AS, Garcia KS, Kriegel L, Puzia M, Sanchez AL, Shelton RC, Weeks DL. FAMily Motivational Engagement Strategy (FAMES) for coordinated specialty care programs: study protocol to evaluate a culturally responsive engagement intervention and equity focused implementation strategies in a hybrid type 2 randomized stepped-wedge trial. Trials. 2025 Dec 16;26(1):568. doi: 10.1186/s13063-025-09280-0. |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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A cluster randomized stepped wedge design with an attention control condition (n=225 dyads) lasting 18 months and an active implementation condition (n=225 dyads) lasting 30 months.
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| Control | Behavioral | participants will receive 12 weeks of automated communication which contain positive messaging, appointment reminders, links to community resources, and coping skills. |
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| General Anxiety Disorder - 7 | Self-report measure to assess symptoms of anxiety. Scores range from 0-21 where scores greater than 10 are indicative of clinically significant anxiety. | Baseline through study completion; repeated measure to assess change through study completion, average of 6 months |
| Client Engagement | Provider reported service utilization. Total number of appointments attended. | Baseline through study completion; repeated measure to assess change through study completion, average of 6 months |
| Client - Patient Health Questionnaire - 9 | A self-report from the individual receiving coordinated specialty care services on their symptoms of depression. Scores range from 0-27 where any score 10 or greater is indicative of clinically significant symptoms of depression. | Baseline through study completion; repeated measure to assess change through study completion, average of 6 months |
| Family - Patient Health Questionnaire - 9 | A self-report from the family member participant on their symptoms of depression. Scores range from 0-27 where any score 10 or greater is indicative of clinically significant symptoms of depression. | Baseline through study completion; repeated measure to assess change through study completion, average of 6 months |
| Community Assessment of Psychic Experiences - Positive Scale 15-items Scale | A self-report measure from the individual receiving the coordinated specialty care services. Scores range from 0-3 where scores greater than 1.46 indicate clinically significant symptoms of psychosis. | Baseline through study completion; repeated measure to assess change through study completion, average of 6 months |
Social connectedness will be measured using four questions (e.g., "I know people who will listen and understand me when I need to talk") from the YSS-F. Scores range from 4 to 20, higher scores indicating greater social connectedness. |
| Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months |
| Treatment Motivation Questionnaire | A self-report measure completed by the family member/support person participant. Includes 26 Likert-scale questions to assess motivation about services. Scores range from 27 to 182 where greater scores indicated greater motivation. | Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months |
| Comprehensive Healthcare | Recruiting | Pasco | Washington | 99301 | United States |
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| Lucid Living | Recruiting | Tacoma | Washington | 98418 | United States |
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| Comprehensive Healthcare | Recruiting | Yakima | Washington | 98902 | United States |
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