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NCT Number: NCT04188366

Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis

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.

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Key information

Conditions

Family Members

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Journeys: Coordinated specialty care

Yakima, Washington, 98902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

Treatment and study plan

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).

Treatment-as-usual

Behavioral

Participants will receive usual services and family-based treatment offered

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. 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

    Provider reported service utilization. Total number of contact hours between provider and family member to measure engagement

  2. 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

    Provider reported service utilization. Percentage of families that dropout (family member declined or missed three consecutive appointments).

  3. Burden Assessment Scale (BAS)

    Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion

    Self-report measure to assess family functioning. Total possible scores range from 10 to 171 (higher scores indicating greater burden)

  4. Iowa Cultural Understanding Assessment

    Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion

    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)

  5. Treatment Self-Regulation Questionnaire (TSRQ)

    Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion

    Self-report measure to assess motivation. Scale ranges from 1=not at all true to 7=very true.

Other outcomes

  1. Organizational Readiness to Change Assessment (ORCA)

    Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion

    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

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Improving Family Engagement in First Episode Psychosis Care

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2019
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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