FAmily Engagement Strategy for Coordinated Specialty Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Family member/support person of an individual enrolled in coordinated specialty care services for less than or equal to 6 months.
18 years of age or older.
During the active implementation period (FAMES) did not participate in the attention control condition.
Disqualifiers
If they do not understand the consent process.
If they do not speak and/or understand English or Spanish.
enrolled in coordinated specialty care services for less than or equal to 6 months.
15 years of age or older.
Trial design
Design model
Sequential
Treatments tested in this trial
FAMES
Behavioral225 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.
Control
Behavioralparticipants will receive 12 weeks of automated communication which contain positive messaging, appointment reminders, links to community resources, and coping skills.
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: Attention Control ConditionActive comparator 1 intervention
Group B: Active ConditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline through study completion; repeated measure to assess change through study completion, average of 3 months2
Engagement in Family Engagement Strategy
Total number of Family Engagement Strategy session attended and the total number of contact minutes to measure engagement.
Time frame
Baseline through study completion; repeated measure to assess change through study completion, average of 3 monthsSecondary outcomes
1
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.
Time frame
Baseline through study completion; repeated measure to assess change through study completion, average of 6 months2
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.
Time frame
Baseline through study completion; repeated measure to assess change through study completion, average of 6 months3
Client Engagement
Provider reported service utilization. Total number of appointments attended.
Time frame
Baseline through study completion; repeated measure to assess change through study completion, average of 6 months4
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.
Time frame
Baseline through study completion; repeated measure to assess change through study completion, average of 6 monthsOther outcomes
1
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.
Time frame
Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months2
Social Connectedness subscale of the Youth Services Survey - Families
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.
Time frame
Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months3
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.
Time frame
Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington State University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov