Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis

Sponsor
Washington State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04188366
Collaborator
National Institute of Mental Health (NIMH) (NIH)
55
1
2
30.9
1.8

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: FAMES
  • Behavioral: Treatment-as-Usual
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Improving Family Engagement in First Episode Psychosis Care
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: FAMES Modification

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

Behavioral: FAMES
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).

Experimental: FAMES Pilot Trial

Pilot testing of FAMES and implementation toolkit

Behavioral: FAMES
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).

Behavioral: Treatment-as-Usual
Participants will receive usual services and family-based treatment offered

Outcome Measures

Primary Outcome Measures

  1. Client Satisfaction Questionnaire-8 (CSQ-8) [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) [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 [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 Outcome Measures

  1. Level of Engagement to measure effectiveness of FAMES [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 [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) [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 [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) [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 Outcome Measures

  1. Organizational Readiness to Change Assessment (ORCA) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Aged 18 years or older;

  2. 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

  3. Received no more than 6 months of services

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 New Journeys: Coordinated specialty care Yakima Washington United States 98902

Sponsors and Collaborators

  • Washington State University
  • National Institute of Mental Health (NIMH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oladunni Oluwoye, Research Assistant Professor, Washington State University
ClinicalTrials.gov Identifier:
NCT04188366
Other Study ID Numbers:
  • 17761-001
  • K01MH117457-01A1
First Posted:
Dec 5, 2019
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Oladunni Oluwoye, Research Assistant Professor, Washington State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022