Family MembersFAMESNCT06945055
FAmily Engagement Strategy for Coordinated Specialty Care
A study testing FAMES in people with Family Members and Implementation, run by Washington State University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Members, Implementation
- What is being tested?
- FAMES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- If they do not understand the consent process.
- If they do not speak and/or understand English or Spanish.
- Primary Service User Inclusion Criteria
- enrolled in coordinated specialty care services for less than or equal to 6 months.
- 15 years of age or older.
- Has a family member/support person willing to engage in the study. during the active implementation period (FAMES) did not participate in the attention control condition.
- if they do not understand the consent process
- If they do not speak and/or understand English or Spanish
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Deschutes County Behavioral Health EASA
Bend, Oregon, 97703
Shannon Brister-Raugust, 541-322-7545, shannon.brister@deschutes.org
- Recruiting
Comprehensive Healthcare
Pasco, Washington, 99301
Lucinda Sanchez, 5094121051, lucinda.sanchez@comphc.org
- Recruiting
Lucid Living
Tacoma, Washington, 98418
Gregory Jones, DNP, 360-539-8899, gregory@transitionalcare.net
- Recruiting
Comprehensive Healthcare
Yakima, Washington, 98902
Victor Larios, MSW, 5095754084, victor.larios@comphc.org
About this study
Official title: Integration of a Culturally Responsive Family Peer Delivered Engagement Strategy in Coordinated Specialty Care
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.
Read the detailed description
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.
- Conditions
- Family Members, Implementation
- Being tested
- FAMES, Control
- Keywords
- early psychosis, family peer, engagement
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAMESBehavioural
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.
ControlBehavioural
participants will receive 12 weeks of automated communication which contain positive messaging, appointment reminders, links to community resources, and coping skills.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Control |
| 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. Receives: Behavioral: FAMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months
Secondary outcomes (6)
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.
Measured: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Mar 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family MembersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Oladunni Oluwoye, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945055
- Sponsor's protocol ID
- 144707-002
- Other IDs
- R01MH136132
- Acronym
- FAMES
- Status last verified
- Nov 2025
- First submitted
- 24 Mar 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41402877
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of a Culturally Responsive Family Peer Delivered Engagement Strategy in Coordinated Specialty Care
- ClinicalTrials.gov ID
- NCT06945055
- Acronym / sponsor ID
- FAMES / 144707-002
- Conditions
- Family Members, Implementation
- Keywords
- early psychosis, family peer, engagement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Attention Control Condition | Active comparator | Behavioral: Control225 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. |
| Active Condition | Active comparator | Behavioral: FAMESThis arm lasts for 30 months during each wave of the clustered randomized stepped wedge design. 225 participants will receive the FAMES intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- If they do not understand the consent process.
- If they do not speak and/or understand English or Spanish.
- Primary Service User Inclusion Criteria
- enrolled in coordinated specialty care services for less than or equal to 6 months.
- 15 years of age or older.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAMES225 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. | Behavioural | Active Condition |
| Controlparticipants will receive 12 weeks of automated communication which contain positive messaging, appointment reminders, links to community resources, and coping skills. | Behavioural | Attention Control Condition |
Primary outcome
Engagement in coordinated specialty care psychoeducation
Time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months
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.
Engagement in Family Engagement Strategy
Time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months
Total number of Family Engagement Strategy session attended and the total number of contact minutes to measure engagement.
6 secondary outcomes
Perceived Stress Scale
Time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
General Anxiety Disorder - 7
Time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Client Engagement
Time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Client - Patient Health Questionnaire - 9
Time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Family - Patient Health Questionnaire - 9
Time frame: 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
Time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Derived from this study: PubMed 41402877Oluwoye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAMES in people with Family Members and Implementation, run by Washington State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oladunni Oluwoye, Associate Professor, Ph.D. (509-368-6805, oladunni.oluwoye@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in coordinated specialty care psychoeducation (time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06945055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.