Psychotic DisordersNCT05500001
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
A study testing Supporting Patients by Family Education in Psychotic Illness Group in people with Psychotic Disorders and Family Members, run by University of Alberta at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 27 years
- Conditions the study is for
- Psychotic Disorders, Family Members, Anosognosia
- What is being tested?
- Supporting Patients by Family Education in Psychotic Illness Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Sep 2022to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Melanie Robles, MD, (780) 983-9773, maduples@ualberta.ca
- Recruiting
Alberta Hospital Edmonton
Edmonton, Alberta, T5J 2J7
Melanie Robles, MD, (780) 983-9773, maduples@ualberta.ca
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Melanie Robles, MD, (780) 983-9773, maduples@ualberta.ca
- Recruiting
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
Melanie Robles, MD, maduples@ualberta.ca, maduples@ualberta.ca
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Psychotic Disorders, Family Members, Anosognosia, Paranoia
- Being tested
- Supporting Patients by Family Education in Psychotic Illness Group
- Keywords
- Young Adult, Psychosis, Family Psychoeducation, Family Burden, Acceptance and Commitment Therapy, LEAP
- Medical subject headings
- Psychotic Disorders, Agnosia, Paranoid Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting Patients by Family Education in Psychotic Illness GroupBehavioural
Psychoeducation for families supporting young adults with psychosis.
| Study group | Role | What they receive |
|---|---|---|
| Family Psychoeducation Intervention Arm | Experimental | These participants will receive the psychoeducation intervention and outcome measures will be taken from them and their young adult service user. The intervention includes psychoeducation on stages of a family's journey, the biopsychosocial basis of psychosis, and skills for coping (Acceptance and Commitment Therapy for Caregivers) and communicating (LEAP). Receives: Behavioral: Supporting Patients by Family Education in Psychotic Illness Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Burden Interview Schedule
assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health
Measured: Baseline-Day 0 (Pre-intervention)
Family Burden Interview Schedule
assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health
Measured: 9-Week Follow-Up (Post-Intervention)
Family Burden Interview Schedule
assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health
Measured: 6-Month Follow-Up (Post-Intervention)
Family Burden Interview Schedule
assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health
Measured: 24-Month Follow-Up (Post-Intervention)
Positive and Negative Symptom Schedule
assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control)
Measured: Baseline-Day 0 (Pre-intervention)
Positive and Negative Symptom Schedule
assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control)
Measured: 9-Week Follow-Up (Post-Intervention)
Positive and Negative Symptom Schedule
assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control)
Measured: 6-Month Follow-Up (Post-Intervention)
Positive and Negative Symptom Schedule
assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control)
Measured: 24-Month Follow-Up (Post-Intervention)
Manchester Short Assessment of Quality of Life
assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items.
Measured: Baseline-Day 0 (Pre-intervention)
Manchester Short Assessment of Quality of Life
assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items.
Measured: 9-Week Follow-Up (Post-Intervention)
Manchester Short Assessment of Quality of Life
assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items.
Measured: 6-Month Follow-Up (Post-Intervention)
Manchester Short Assessment of Quality of Life
assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items.
Measured: 24-Month Follow-Up (Post-Intervention)
Secondary outcomes (15)
Inpatient Readmission Rate
Readmission rate for mental health diagnosis within 30 days of an inpatient discharge
Measured: 12-24 months post-intervention
Inpatient Readmission Rate
Readmission rate for mental health diagnosis within 30 days of an inpatient discharge
Measured: 12-months pre-intervention
Inpatient Readmission Rate
Readmission rate for mental health diagnosis within 30 days of an inpatient discharge
Measured: 12-months post-intervention
Inpatient Admission Frequency
Frequency of hospital admissions for mental health diagnosis
Measured: 12-months pre-intervention
Inpatient Admission Frequency
Frequency of hospital admissions for mental health diagnosis
Measured: 12-months post-intervention
Inpatient Admission Frequency
Frequency of hospital admissions for mental health diagnosis
Measured: 12-24 months post-intervention
Emergency Department Visit Frequency
Frequency of emergency departments visits within 30 days of last emergency presentation
Measured: 12-months pre-intervention
Emergency Department Visit Frequency
Frequency of emergency departments visits within 30 days of last emergency presentation
Measured: 12-months post-intervention
Emergency Department Visit Frequency
Frequency of emergency departments visits within 30 days of last emergency presentation
Measured: 12-24 months post-intervention
Community Appointment Frequency
Appointment frequency for community-based services
Measured: 12-months pre-intervention
Community Appointment Frequency
Appointment frequency for community-based services
Measured: 12-months post-intervention
Community Appointment Frequency
Appointment frequency for community-based services
Measured: 12-24 months post-intervention
Crisis Service Frequency
Frequency of crisis calls and visits
Measured: 12-months pre-intervention
Crisis Service Frequency
Frequency of crisis calls and visits
Measured: 12-months post-intervention
Crisis Service Frequency
Frequency of crisis calls and visits
Measured: 12-24 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A longitudinal pre-post study design will be used. A non-equivalent comparison group will be available for some measures.
- Masking
- None (open label)
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services, Families Supporting Adults with Mental Illness-Alberta
- Responsible party
- Sponsor
- Investigators
- Melanie Robles, md, Principal investigator, University of AlbertaAdam Abba-Aji, MD, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500001
- Sponsor's protocol ID
- Pro00110691
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD datasets that will be collected and analyzed for this study will be available by request from the corresponding author. Given the small study population, narrow geographic region of recruitment, and Alberta Health Services\' data sharing policies, potentially identifying demographic data will not be available.
Publications
Alberta Health Services. (2018). Patient and Family Centered Care Resource Kit: How to Improve the Patient Experience. Quality and Healthcare Improvement, Engagement and Patient Experience Department.
Amador X. (2020).I Am Not Sick, I Don't Need Help! How To Help Someone Accept Treatment. New York: Vida Press
American Psychological Association [APA]. (2011). Family Interventions. Retrieved on August 9, 2022 from https://www.apa.org/pi/about/publications/caregivers/practice-settings/intervention/family
Day, K., & Petrakis, M. (2017). Family interventions in early psychosis service delivery: A systematized review. Social Work in Mental Health, 15(6): 632-650. doi:10.1080/15332985.2016.1271381
Day K, Starbuck R, Petrakis M. Family group interventions in an early psychosis program: A re-evaluation of practice after 10 years of service delivery. Int J Soc Psychiatry. 2017 Aug;63(5):433-438. doi: 10.1177/0020764017710301. Epub 2017 May 24.
PubMed 28537124Early Psychosis Guidelines Writing Group and EPPIC National Support Program (2016). Australian Clinical Guidelines for Early Psychosis, 2nd edition update, Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne.
Ewertzon M, Hanson E. Support Interventions for Family Members of Adults with Mental Illness: A Narrative Literature Review. Issues Ment Health Nurs. 2019 Sep;40(9):768-780. doi: 10.1080/01612840.2019.1591547. Epub 2019 May 30.
PubMed 31145025Hayes, S.C., Strosahl, K.D., & Wilson, K.G. (1999)Acceptance and commitment therapy: An experiential approach to behavior change. Guilford Press.
Jolley S, Johns LC, O'Donoghue E, Oliver J, Khondoker M, Byrne M, Butler L, De Rosa C, Leal D, McGovern J, Rasiukeviciute B, Sim F, Morris E. Group acceptance and commitment therapy for patients and caregivers in psychosis services: Feasibility of training and a preliminary randomized controlled evaluation. Br J Clin Psychol. 2020 Nov;59(4):524-551. doi: 10.1111/bjc.12265. Epub 2020 Sep 17.
PubMed 32944971Kreyenbuhl J, Buchanan RW, Dickerson FB, Dixon LB; Schizophrenia Patient Outcomes Research Team (PORT). The Schizophrenia Patient Outcomes Research Team (PORT): updated treatment recommendations 2009. Schizophr Bull. 2010 Jan;36(1):94-103. doi: 10.1093/schbul/sbp130. Epub 2009 Dec 2.
PubMed 19955388MacCourt, P. (2013). Family Caregivers Advisory Committee, Mental Health Commission of Canada. National Guidelines for a Comprehensive Service System to Support Family Caregivers of Adults with Mental Health Problems and Illnesses. Calgary, AB: Mental Health Commission of Canada. Retrieved from: http://www.mentalhealthcommission.ca
McFarlane WR, Dixon L, Lukens E, Lucksted A. Family psychoeducation and schizophrenia: a review of the literature. J Marital Fam Ther. 2003 Apr;29(2):223-45. doi: 10.1111/j.1752-0606.2003.tb01202.x.
PubMed 12728780Poon, A.W.C., Curtis, J., Howard, A., Ward, P.B., & Lappin, J.M. (2019). Health of Carers of Young People with Early Psychosis: A Biopsychosocial Approach. Australian Social Work, 72(3): 260-273, DOI: 10.1080/0312407X.2018.1530269
Rachamim L, Nacasch N, Sinay I. Complicated Grief, Depression, Health and Attachment Style in First Degree Relatives of Individuals with a Chronic Psychotic Disorders. Community Ment Health J. 2022 Apr;58(3):526-535. doi: 10.1007/s10597-021-00848-z. Epub 2021 Jun 16.
PubMed 34132930Rosas-Santiago, F.J., Genchi, J.J., Heredia, I.S., & Zamora, V.E.R. (2022). Psychoeducation and group acceptance and commitment therapy as psychological support strategies for informal caregivers of patients with a first psychotic episode: An experimental study. Psychosis: Psychological, Social and Integrative Approaches.[Preprint]. doi:10.1080/17522439.2022.2061041.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05500001
- Acronym / sponsor ID
- Pro00110691
- Conditions
- Psychotic Disorders, Family Members, Anosognosia, Paranoia
- Keywords
- Young Adult, Psychosis, Family Psychoeducation, Family Burden, Acceptance and Commitment Therapy, LEAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services, Families Supporting Adults with Mental Illness-Alberta
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A longitudinal pre-post study design will be used. A non-equivalent comparison group will be available for some measures.
| Arm | Type | Receives |
|---|---|---|
| Family Psychoeducation Intervention Arm | Experimental | Behavioral: Supporting Patients by Family Education in Psychotic Illness GroupThese participants will receive the psychoeducation intervention and outcome measures will be taken from them and their young adult service user. The intervention includes psychoeducation on stages of a family's journey, the biopsychosocial basis of psychosis, and skills for coping (Acceptance and Commitment Therapy for Caregivers) and communicating (LEAP). |
Who may qualify
- Ages
- 17 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supporting Patients by Family Education in Psychotic Illness GroupPsychoeducation for families supporting young adults with psychosis. | Behavioural | Family Psychoeducation Intervention Arm |
Primary outcome
Family Burden Interview Schedule
Time frame: Baseline-Day 0 (Pre-intervention)
assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health
Family Burden Interview Schedule
Time frame: 9-Week Follow-Up (Post-Intervention)
assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health
Family Burden Interview Schedule
Time frame: 6-Month Follow-Up (Post-Intervention)
assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health
Family Burden Interview Schedule
Time frame: 24-Month Follow-Up (Post-Intervention)
assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health
Positive and Negative Symptom Schedule
Time frame: Baseline-Day 0 (Pre-intervention)
assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control)
Positive and Negative Symptom Schedule
Time frame: 9-Week Follow-Up (Post-Intervention)
assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control)
Positive and Negative Symptom Schedule
Time frame: 6-Month Follow-Up (Post-Intervention)
assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control)
Positive and Negative Symptom Schedule
Time frame: 24-Month Follow-Up (Post-Intervention)
assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control)
Manchester Short Assessment of Quality of Life
Time frame: Baseline-Day 0 (Pre-intervention)
assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items.
Manchester Short Assessment of Quality of Life
Time frame: 9-Week Follow-Up (Post-Intervention)
assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items.
Manchester Short Assessment of Quality of Life
Time frame: 6-Month Follow-Up (Post-Intervention)
assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items.
Manchester Short Assessment of Quality of Life
Time frame: 24-Month Follow-Up (Post-Intervention)
assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items.
15 secondary outcomes
Inpatient Readmission Rate
Time frame: 12-24 months post-intervention
Inpatient Readmission Rate
Time frame: 12-months pre-intervention
Inpatient Readmission Rate
Time frame: 12-months post-intervention
Inpatient Admission Frequency
Time frame: 12-months pre-intervention
Inpatient Admission Frequency
Time frame: 12-months post-intervention
Inpatient Admission Frequency
Time frame: 12-24 months post-intervention
Emergency Department Visit Frequency
Time frame: 12-months pre-intervention
Emergency Department Visit Frequency
Time frame: 12-months post-intervention
Emergency Department Visit Frequency
Time frame: 12-24 months post-intervention
Community Appointment Frequency
Time frame: 12-months pre-intervention
Community Appointment Frequency
Time frame: 12-months post-intervention
Community Appointment Frequency
Time frame: 12-24 months post-intervention
Crisis Service Frequency
Time frame: 12-months pre-intervention
Crisis Service Frequency
Time frame: 12-months post-intervention
Crisis Service Frequency
Time frame: 12-24 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- BackgroundAlberta Health Services. (2018). Patient and Family Centered Care Resource Kit: How to Improve the Patient Experience. Quality and Healthcare Improvement, Engagement and Patient Experience Department.
- BackgroundAmador X. (2020).I Am Not Sick, I Don't Need Help! How To Help Someone Accept Treatment. New York: Vida Press
- BackgroundAmerican Psychological Association [APA]. (2011). Family Interventions. Retrieved on August 9, 2022 from https://www.apa.org/pi/about/publications/caregivers/practice-settings/intervention/family
- BackgroundDay, K., & Petrakis, M. (2017). Family interventions in early psychosis service delivery: A systematized review. Social Work in Mental Health, 15(6): 632-650. doi:10.1080/15332985.2016.1271381
- Background: PubMed 28537124Day K, Starbuck R, Petrakis M. Family group interventions in an early psychosis program: A re-evaluation of practice after 10 years of service delivery. Int J Soc Psychiatry. 2017 Aug;63(5):433-438. doi: 10.1177/0020764017710301. Epub 2017 May 24.
- BackgroundEarly Psychosis Guidelines Writing Group and EPPIC National Support Program (2016). Australian Clinical Guidelines for Early Psychosis, 2nd edition update, Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne.
- Background: PubMed 31145025Ewertzon M, Hanson E. Support Interventions for Family Members of Adults with Mental Illness: A Narrative Literature Review. Issues Ment Health Nurs. 2019 Sep;40(9):768-780. doi: 10.1080/01612840.2019.1591547. Epub 2019 May 30.
- BackgroundHayes, S.C., Strosahl, K.D., & Wilson, K.G. (1999)Acceptance and commitment therapy: An experiential approach to behavior change. Guilford Press.
- Background: PubMed 32944971Jolley S, Johns LC, O'Donoghue E, Oliver J, Khondoker M, Byrne M, Butler L, De Rosa C, Leal D, McGovern J, Rasiukeviciute B, Sim F, Morris E. Group acceptance and commitment therapy for patients and caregivers in psychosis services: Feasibility of training and a preliminary randomized controlled evaluation. Br J Clin Psychol. 2020 Nov;59(4):524-551. doi: 10.1111/bjc.12265. Epub 2020 Sep 17.
- Background: PubMed 19955388Kreyenbuhl J, Buchanan RW, Dickerson FB, Dixon LB; Schizophrenia Patient Outcomes Research Team (PORT). The Schizophrenia Patient Outcomes Research Team (PORT): updated treatment recommendations 2009. Schizophr Bull. 2010 Jan;36(1):94-103. doi: 10.1093/schbul/sbp130. Epub 2009 Dec 2.
- BackgroundMacCourt, P. (2013). Family Caregivers Advisory Committee, Mental Health Commission of Canada. National Guidelines for a Comprehensive Service System to Support Family Caregivers of Adults with Mental Health Problems and Illnesses. Calgary, AB: Mental Health Commission of Canada. Retrieved from: http://www.mentalhealthcommission.ca
- Background: PubMed 12728780McFarlane WR, Dixon L, Lukens E, Lucksted A. Family psychoeducation and schizophrenia: a review of the literature. J Marital Fam Ther. 2003 Apr;29(2):223-45. doi: 10.1111/j.1752-0606.2003.tb01202.x.
- Individual participant dataSharing planned: Yes. All IPD datasets that will be collected and analyzed for this study will be available by request from the corresponding author. Given the small study population, narrow geographic region of recruitment, and Alberta Health Services\' data sharing policies, potentially identifying demographic data will not be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie Robles, md principal investigator
University of Alberta
Adam Abba-Aji, MD principal investigator
Alberta Health services
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supporting Patients by Family Education in Psychotic Illness Group in people with Psychotic Disorders and Family Members, run by University of Alberta at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Robles, MD ((780) 983-9773, maduples@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Burden Interview Schedule (time frame: Baseline-Day 0 (Pre-intervention)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05500001, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.