Family MembersNCT04188366
Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis
A study testing FAMES and Treatment-as-Usual in people with Family Members, run by Washington State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Members
- What is being tested?
- FAMES and Treatment-as-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Aged 18 years or older;
- 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
- Received no more than 6 months of services
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Journeys: Coordinated specialty care
Yakima, Washington, 98902
About this study
Official title: Improving Family Engagement in First Episode Psychosis Care
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.
Read the 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.
- Conditions
- Family Members
- Being tested
- FAMES, Treatment-as-Usual
- Keywords
- Coordinated Specialty Care, Family Engagement, First Episode Psychosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAMESBehavioural
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).
Treatment-as-UsualBehavioural
Participants will receive usual services and family-based treatment offered
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: FAMES |
| FAMES Pilot Trial | Experimental | Pilot testing of FAMES and implementation toolkit Receives: Behavioral: FAMES; Behavioral: Treatment-as-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Month 1 of treatment period and month 1 follow-up period; repeated measure to assess change in acceptability and feasibility
Secondary outcomes (5)
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
Measured: 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
Provider reported service utilization. Percentage of families that dropout (family member declined or missed three consecutive appointments).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jan 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
- NCT04188366
- Sponsor's protocol ID
- 17761-001
- Other IDs
- K01MH117457-01A1
- Status last verified
- Apr 2025
- First submitted
- 27 Nov 2019
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32847910
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Family Engagement in First Episode Psychosis Care
- ClinicalTrials.gov ID
- NCT04188366
- Acronym / sponsor ID
- 17761-001
- Conditions
- Family Members
- Keywords
- Coordinated Specialty Care, Family Engagement, First Episode Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 5 Dec 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAMES Modification | Experimental | Behavioral: FAMES3-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 | Behavioral: FAMES, Behavioral: Treatment-as-UsualPilot testing of FAMES and implementation toolkit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older;
- 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
- Received no more than 6 months of services
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FAMESParticipants 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). | Behavioural | FAMES Modification, FAMES Pilot Trial |
| Treatment-as-UsualParticipants will receive usual services and family-based treatment offered | Behavioural | FAMES Pilot Trial |
Primary outcome
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: 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)
Time frame: 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.
Qualitative interviews
Time frame: 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
5 secondary outcomes
Level of Engagement to measure effectiveness of FAMES
Time frame: 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
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Burden Assessment Scale (BAS)
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Iowa Cultural Understanding Assessment
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Treatment Self-Regulation Questionnaire (TSRQ)
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Derived from this study: PubMed 32847910Oluwoye 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAMES and Treatment-as-Usual in people with Family Members, run by Washington State University at 1 site 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 3 inclusion and 0 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: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire-8 (CSQ-8) (time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion). The study lists 3 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 NCT04188366, 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 20 Apr 2025.