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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new support system called the Family Peer Navigator model, designed to help Black and African American families engage in specialized care for early signs of psychosis. The researchers aim to determine if a family peer navigator can improve access to and engagement with necessary mental health services. Participants will either receive support from a Family Peer Navigator or attend basic educational sessions with service links. The trial seeks Black or African American adults with a loved one showing early risk of psychosis. As an unphased trial, it offers a unique opportunity to contribute to innovative mental health support strategies for 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 prior data suggests that the Family Peer Navigator model is safe for early psychosis?

Research has shown that the Family Peer Navigator model for early psychosis is generally well-received. Although studies do not list specific side effects, the main focus is on improving access to care and supporting families, particularly those from Black/African American communities. Previous studies have found that similar family support programs can be helpful without causing significant problems. Since this trial is not in its earliest stage, there is some confidence in its safety. The aim is to help families connect better with specialized care, using a supportive and non-invasive method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Family Peer Navigator for Early Psychosis approach is unique because it leverages the power of peer support from family members, offering a personalized and relatable connection that traditional treatments might lack. Unlike standard treatments that often rely heavily on medication or clinical interventions, this method involves trained family members providing psychoeducation and support, which could help bridge the gap between clinical care and real-life application. Researchers are excited about this because it not only empowers families but also has the potential to improve engagement and outcomes for those experiencing early psychosis by fostering understanding and support within the home environment.

What evidence suggests that this trial's treatments could be effective for early psychosis?

Research has shown that involving family can greatly improve recovery for people experiencing early psychosis. In a study with 349 participants receiving treatment for early psychosis, those whose family members participated in their care during the first month had better outcomes. This trial will compare two approaches: the Family Peer Navigator model and Care Coordination. Family Peer Navigator programs, like the one being tested, aim to boost family involvement. These programs have been shown to help reduce the chances of symptoms returning and lower stress for caregivers. This approach is especially helpful for Black/African American families because it is culturally informed and tailored to their needs. Overall, early family involvement in the treatment process seems to improve recovery. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/family-peer-navigator-for-early-psychosis-df61c

Family Peer Navigator for Early Psychosis 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 ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/13/7/e075729.abstract

Community-based family peer navigator programme to ... Developing and implementing a culturally informed FAmily Motivational Engagement Strategy (FAMES) to increase family engagement in first episode psychosis progr ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37407058/

A protocol for a hybrid type I feasibility study - PubMed - NIH Community-based family peer navigator programme to facilitate linkage to coordinated specialty care for early psychosis among Black families ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2017.00371/full

Do Family Interventions Improve Outcomes in Early ... Family interventions for psychosis (FIp) are effective in reducing service user relapse and carer distress in people with schizophrenia-spectrum conditions.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10335551/

Community-based family peer navigator programme to ... While, CSC has demonstrated positive impacts on treatment outcomes among youth in the early stages of psychosis, many families, especially Black ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4490051/

The NAVIGATE Program for First Episode Psychosis NAVIGATE is intended for individuals whose acute psychotic symptoms have remitted or been stabilized, as well as those who continue to have severe symptoms ...

7. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2018.00406/full

Editorial: Family Interventions in Psychosis Change ... The papers in this Research Topic speak to the broad evidence base in support of the rationale and delivery of family interventions with early psychosis ...