Clinical trial NCT05500001: Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Official title: Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Family Members
Anosognosia
Paranoia
Keywords: Young Adult
Psychosis
Family Psychoeducation
Family Burden
Acceptance and Commitment Therapy
LEAP
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: Families Supporting Adults with Mental Illness-Alberta
First posted: 2022-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A longitudinal pre-post study design will be used. A non-equivalent comparison group will be available for some measures.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: A lack of education, resources, and support for family carers of young adults with psychotic illnesses leaves them ill-equipped to support their loved one. Although family support groups exist, few groups offer evidence-based, skills-focused, psychoeducation taught by certified professionals and provided on a public-health level. By equipping families with skills and knowledge, public healthcare harnesses a powerful ally to maintain community stabilization.

Aims: The primary study goal is to implement a psychoeducation intervention for family carers supporting young adults with psychosis to reduce family burden and foster community stabilization of service users.

Methods: A longitudinal pre-post design will be used to assess the long-term effectiveness of the psychoeducation intervention for family carers supporting a young adult with psychosis on service utilization and functional indexes. Nine expert-reviewed, and family peer-informed psychoeducation modules are administered in 2-hour sessions over 9 weeks to family carers.

Conclusion: Presenting the novel approach of an expert-reviewed, peer-informed psychoeducation intervention for family carers, with a focus on knowledge and skill development, the researchers contribute to literature and best practice in patient and family-centered care.

Detailed description: Background:

A lack of education, resources, and support for family carers of young adults with psychotic illnesses leaves them ill-equipped to support their loved one. Often family carers are excluded from the discharge planning process or are unaware of how to support of their loved one in community. Although best practice documents champion family involvement the implementation of these guidelines is challenge and families are often excluded from care.There is evidence of the disparity between best practice documents and true practice in the literature.

Family inclusion also addresses the impact of psychotic disease on the family's functioning and mental health. Psychotic illness (e.g., anosognosia, paranoia) can interfere with relational health and the natural maturation of family relationships over time. Families face extreme challenges when supporting a young adult with psychotic illness including social isolation, likely because their typical social supports are unable to relate to their situation, prompting them to seek support with those who share their situation (i.e., family support groups). Family carers, even in the face of these hardships, work with great tenacity toward improving service user stability in community.

There is a lack of high-quality effectiveness research showing longitudinal evidence for treatment effects on the carer and the young person in family psychoeducation groups. For example, one study provided a family intervention that was primarily knowledge- and support-based. These researchers used a pre-post design to assess the mental health knowledge, but did not assess long-term effectiveness of the group, overall family functioning, and functioning of the service user.

The intent for this longitudinal pre-post study is to evaluate the effect of skills-based educational programming for family carers supporting young adults admitted to or discharged from hospital with psychosis of any etiology on 6-month and 24-month service user readmission rates and service user/family functional indexes. The investigators hypothesize that system integration of a program which delivers early support for the family carers by way of an educational intervention beginning prior to or shortly after hospital discharge may reduce family burden as well as improve short- and long-term patient outcomes. To the investigators' knowledge, this study is the first to evaluate effectiveness of a family carer skills-based education intervention within a public healthcare system.

The investigators will use a longitudinal pretest-posttest design with a non-equivalent control group to evaluate the short- and long-term effectiveness of this family psychoeducation intervention. While a control group can be used for comparison of the service utilization data for young adults with psychosis using archival data from health records, gathering long-term control group data from families not participating in the trial is unethical in that denial of an intervention for up to two years is potentially harmful to both the families and the young adult they support. Likewise, control group data gathered directly from young adult service users presents the same ethical problem. Using archival health utilization data, however, allows us to exclude any service users' whose families have elected to access the psychoeducation program within the 2-year timeframe of the study. This allows us to find control data for health service utilization while not withholding the psychoeducation intervention from those who seek it. The investigators acknowledge that the control group is non-equivalent because families and service users who chose not to engage in the study may vary systematically from those who did.

Each measure will be taken pre-intervention (i.e., baseline), post-intervention, then again at 6- and 24-months post-intervention. A gift card incentive ($25.00 per data collection meeting) will be provided to family and young adult participants as a token of appreciation for their participation.

Service utilization data will be collected for 12-months pre-intervention to be compared to 12-months post-intervention and 12-24 months post-intervention.

Recruitment:

Study information will be disseminated by clinical teams and through community organizations, and family carers meeting eligibility criteria will self-identify for participation. Once recruited, and with family consent, young adult service users of participating family carers will be contacted for recruitment into the study.

Measures:

A variety of measures will be used to collect functional index data for the family members and the young adult service users. Health utilization data will be mined for 12-months pre-intervention, and up to 24-months post-intervention to assess long term service user outcomes. See Outcome Measures section for details.

Secondary Data Control Group:

While randomization into treatment and control groups was not feasible for this study, non-equivalent control group data can be mined from health records for young adults whose family did not participate in the study.

Intervention:

The educational modules are developed by experts in the areas of interest and are evidence based, family peer-informed and expert peer-reviewed. The curriculum consists of 9 modules delivered weekly over 9 weeks. Evidence-based content includes the Listen-Empathize-Agree-Partner (LEAP) communication Program, and Acceptance and Commitment Therapy. The family psychoeducation classes are to take place at a designated AHS location.

Limitations and Conclusion:

The described protocol is one of the first attempts in the literature to evaluate an evidence-based intervention for carers of young adults with psychotic illness. The current study builds on others by incorporating psychoeducational elements, modules specific to the LEAP approach, and modules specific to ACT. Furthermore, the design of the study intends to gather longitudinal 24-month post-intervention data from carers and service users, including health service utilization data.

Several limitations must be considered with regards to this protocol. First, using a pre-post design the investigators cannot draw causal conclusions regarding the effect of the intervention. To address this limitation the investigators will use secondary data from health records as a non-equivalent control group for health utilization data. A second limitation is that participants self-select for the study, and may differ systematically from those who choose not to participate. For example, the sample will likely be biased towards families who are already supportive and involved in their young adults' care. The sample of young adults participating will be additionally biased because those who are especially unwell may be unable to participate. By comparing the health utilization data of the participants to the nonequivalent control group in a longitudinal design the investigators will gain some evidence to rule out history effects. Even with these limitations, the described design builds on existing knowledge of effective family psychoeducation groups and their long term effects on young adults experiencing psychosis.

Eligibility criteria: Inclusion Criteria:

* Young adult service user is aged 17-27 at time of recruitment
* Young adult service user has had an admission or discharge from an Alberta Health Services or Covenant Health psychiatric unit for psychosis in the Edmonton Zone within previous 12-months

Exclusion Criteria:

* Not proficient in English
* Young adult service user has NOT had an admission or discharge from an Alberta Health Services or Covenant Health psychiatric unit for psychosis in the Edmonton Zone within previous 12-months

Primary outcomes:
measure: Family Burden Interview Schedule
timeFrame: Baseline-Day 0 (Pre-intervention)
measure: Family Burden Interview Schedule
timeFrame: 9-Week Follow-Up (Post-Intervention)
measure: Family Burden Interview Schedule
timeFrame: 6-Month Follow-Up (Post-Intervention)
measure: Family Burden Interview Schedule
timeFrame: 24-Month Follow-Up (Post-Intervention)
measure: Positive and Negative Symptom Schedule
timeFrame: Baseline-Day 0 (Pre-intervention)
measure: Positive and Negative Symptom Schedule
timeFrame: 9-Week Follow-Up (Post-Intervention)
measure: Positive and Negative Symptom Schedule
timeFrame: 6-Month Follow-Up (Post-Intervention)
measure: Positive and Negative Symptom Schedule
timeFrame: 24-Month Follow-Up (Post-Intervention)
measure: Manchester Short Assessment of Quality of Life
timeFrame: Baseline-Day 0 (Pre-intervention)
measure: Manchester Short Assessment of Quality of Life
timeFrame: 9-Week Follow-Up (Post-Intervention)
measure: Manchester Short Assessment of Quality of Life
timeFrame: 6-Month Follow-Up (Post-Intervention)
measure: Manchester Short Assessment of Quality of Life
timeFrame: 24-Month Follow-Up (Post-Intervention)
Secondary outcomes:
measure: Inpatient Readmission Rate
timeFrame: 12-24 months post-intervention
measure: Inpatient Readmission Rate
timeFrame: 12-months pre-intervention
measure: Inpatient Readmission Rate
timeFrame: 12-months post-intervention
measure: Inpatient Admission Frequency
timeFrame: 12-months pre-intervention
measure: Inpatient Admission Frequency
timeFrame: 12-months post-intervention
measure: Inpatient Admission Frequency
timeFrame: 12-24 months post-intervention
measure: Emergency Department Visit Frequency
timeFrame: 12-months pre-intervention
measure: Emergency Department Visit Frequency
timeFrame: 12-months post-intervention
measure: Emergency Department Visit Frequency
timeFrame: 12-24 months post-intervention
measure: Community Appointment Frequency
timeFrame: 12-months pre-intervention
measure: Community Appointment Frequency
timeFrame: 12-months post-intervention
measure: Community Appointment Frequency
timeFrame: 12-24 months post-intervention
measure: Crisis Service Frequency
timeFrame: 12-months pre-intervention
measure: Crisis Service Frequency
timeFrame: 12-months post-intervention
measure: Crisis Service Frequency
timeFrame: 12-24 months post-intervention
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Hospital Edmonton
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Melanie Robles, md
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Health services
name: Adam Abba-Aji, MD
role: PRINCIPAL_INVESTIGATOR
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