Family Peer Navigator for Early Psychosis

Recruiting at 1 trial location

Overseen By Bryony Stokes, B.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington State University

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Building upon formative research, this mixed methods study will be conducted in three phases to develop, refine, and pilot-test a multi-component Family Peer Navigator model designed to increase access to and initial engagement in coordinated specialty care for early psychosis among Black/African American families.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Family Peer Navigator treatment for early psychosis?

Research shows that when family members are actively involved in the treatment of individuals with early psychosis, it can lead to better engagement and attendance in treatment programs. Additionally, peer support, including family peer support, has been found to improve self-esteem, quality of life, and emotional well-being, while also reducing hospitalizations and stigma. ^{1 2 3 4 5}

How is the Family Peer Navigator for Early Psychosis treatment different from other treatments for early psychosis?

The Family Peer Navigator for Early Psychosis treatment is unique because it involves family members who have lived experience with psychosis, providing support and guidance to other families. This approach helps reduce stigma, fosters hope, and improves coping strategies, which are not typically addressed by standard medical treatments. ^{2 3 6 7 8}

Eligibility Criteria

This trial is for Black/African American adults over 18 with a family member at risk of psychosis, indicated by a score of ≥3 on the Prodromal Questionnaire-Brief Version. Participants must speak English and be able to understand the consent process. Those already eligible for coordinated specialty care are excluded.

Inclusion Criteria

Identifies as Black/African American

Your loved one has been identified as at risk for developing psychosis based on a questionnaire score of 3 or higher.

Exclusion Criteria

Family members who cannot understand the consent process

Black/African American families referred to coordinated specialty care and who have already been determined eligible for services by providers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Refinement

Development and refinement of the Family Peer Navigator model with 10 family member participants over a four-month open trial

16 weeks

Pilot Trial

Randomized pilot trial of the Family Peer Navigator model with 40 families to assess acceptability, feasibility, and preliminary impact

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Care Coordination
• Family Peer Navigator for Early Psychosis

Trial Overview The study is testing a Family Peer Navigator model designed to help Black families access and engage in early psychosis care. It involves developing, refining, and pilot-testing this multi-component approach through mixed methods research.

Participant Groups

Group I: Family Peer Navigator model Psychosis Phase III Experimental Treatment 1 Intervention

Family member participants randomized to the Family Peer Navigator condition will participate in two sessions for introduction/assessment, four individual psychoeducation sessions, and six brief check ins delivered by Family Peer Navigators.

Group II: Care Coordination Phase III Active Control 1 Intervention

Family member participants randomized to the active control will receive two brief psychoeducation sessions, two brief check ins across one month and linked to appropriate services.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

In a study of 349 service users in early psychosis treatment, those whose family members were engaged in their care during the first month were significantly more likely to stay engaged and attend appointments over the next 7 months.

For every additional appointment attended by family members in the first 24 months, the likelihood of service users remaining engaged increased by 14%, highlighting the crucial role of family involvement in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking a Look at How Family Member Engagement Influences Service User Engagement in New Journeys: a Coordinated Specialty Care Program. Oluwoye, O., Fraser, ER., Kordas, G.[2023]

Family members of individuals with early psychosis play a crucial role in their loved ones' engagement with treatment, but they face significant stress and uncertainty in this role, as revealed through interviews with 18 family members.

Supportive elements of the clinical program, such as ongoing outreach, communication, and individualized care, are highly valued by families, highlighting the need for tailored support to help them manage their responsibilities and emotional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family member engagement with early psychosis specialty care. Lucksted, A., Stevenson, J., Nossel, I., et al.[2019]

Integrating peer support workers (PSW) and family peer support workers (FPSW) into early intervention for psychosis services has shown positive impacts on young patients, including improved self-esteem, quality of life, and emotional well-being, while also facilitating rehabilitation and reducing hospitalizations.

Despite the benefits, challenges such as planning, funding, role definition, and training need to be addressed to optimize the integration of peer support in clinical teams, highlighting the importance of collaboration among health professionals, managers, and decision-makers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Peer support for recovery in early intervention for psychosis: Issues surrounding its implementation in Quebec and the French-speaking world]. Pires de Oliveira Padilha, P., Gagné, G., Iyer, SN., et al.[2023]

The pilot study of the Norwegian version of the REACT program, which included web-based resources and phone support from family therapists, showed significant reductions in stress and expressed emotions among 19 relatives of people with psychosis after 26 weeks.

User feedback highlighted that the program empowered relatives by turning knowledge into action and improving their involvement with health services, although barriers such as clinician resistance to technology and lack of reimbursement were noted as challenges for broader implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Care for Caregivers of People With Psychosis: Mixed Methods Pilot Study. Romm, KL., Nilsen, L., Gjermundsen, K., et al.[2021]

The NAVIGATE program, developed under the RAISE initiative, is a comprehensive, team-based treatment designed specifically for individuals experiencing their first episode of psychosis, incorporating psychosocial components like family education and individual resiliency training.

This program aims to improve psychological and functional health through a collaborative approach, and a recent cluster-randomized controlled trial has been completed to evaluate its effectiveness compared to standard community care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The NAVIGATE Program for First-Episode Psychosis: Rationale, Overview, and Description of Psychosocial Components. Mueser, KT., Penn, DL., Addington, J., et al.[2018]

The E Sibling Project's online intervention for siblings of individuals with psychosis was found to be feasible and acceptable, with 19 out of 20 participants engaging with the resource over a 4-week period.

Participants reported the intervention as helpful and relevant, although improvements in navigation and intuitiveness are needed to enhance usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of online psychoeducation for siblings of people with psychosis. Sin, J., Henderson, C., Norman, I.[2022]

Family members and carers play a crucial role in supporting individuals with schizophrenia, often starting even before diagnosis by helping to seek medical attention.

Interventions that involve family members during early psychosis can reduce their distress and improve their ability to support the patient, highlighting the need for better communication and resources from the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the needs of carers during early psychosis. Jones, K.[2011]

Family peer support groups for caregivers of individuals with psychosis provide significant benefits, including emotional support, knowledge about the illness, and improved caregiving skills, as reported by 44 participants in a study conducted in Montreal.

Integrating family peer support into early intervention services for psychosis can enhance family engagement and reduce caregiver burden, promoting recovery for both patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-driven family support services in the context of first-episode psychosis: Participant perceptions from a Canadian early intervention programme. Levasseur, MA., Ferrari, M., McIlwaine, S., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Taking a Look at How Family Member Engagement Influences Service User Engagement in New Journeys: a Coordinated Specialty Care Program. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

Family member engagement with early psychosis specialty care. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

[Peer support for recovery in early intervention for psychosis: Issues surrounding its implementation in Quebec and the French-speaking world]. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Remote Care for Caregivers of People With Psychosis: Mixed Methods Pilot Study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The NAVIGATE Program for First-Episode Psychosis: Rationale, Overview, and Description of Psychosocial Components. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Usability of online psychoeducation for siblings of people with psychosis. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Addressing the needs of carers during early psychosis. [2011]

8. Australia pubmed.ncbi.nlm.nih.gov

Peer-driven family support services in the context of first-episode psychosis: Participant perceptions from a Canadian early intervention programme. [2019]