Recruiting

Observational Study

Sponsor:

University of Alberta

Code:

NCT05500001

Conditions

Psychotic Disorders

Family Members

Anosognosia

Paranoia

Eligibility Criteria

Sex: All

Age: 17 - 27

Healthy Volunteers: Not accepted

Interventions

Supporting Patients by Family Education in Psychotic Illness Group

Study Details

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.

Conditions

Psychotic Disorders

Family Members

Anosognosia

Paranoia

Study ID

NCT05500001

Start date

Sep 1, 2022

Status verified date

Nov, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17 - 27

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

113 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Family Psychoeducation Intervention Arm

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).

Interventions

Supporting Patients by Family Education in Psychotic Illness Group

Psychoeducation for families supporting young adults with psychosis.

Primary outcome measure

  • Family Burden Interview Schedule [ Time Frame: Baseline-Day 0 (Pre-intervention) ]
  • Family Burden Interview Schedule [ Time Frame: 9-Week Follow-Up (Post-Intervention) ]
  • Family Burden Interview Schedule [ Time Frame: 6-Month Follow-Up (Post-Intervention) ]
  • Family Burden Interview Schedule [ Time Frame: 24-Month Follow-Up (Post-Intervention) ]
  • Positive and Negative Symptom Schedule [ Time Frame: Baseline-Day 0 (Pre-intervention) ]
  • Positive and Negative Symptom Schedule [ Time Frame: 9-Week Follow-Up (Post-Intervention) ]
  • Positive and Negative Symptom Schedule [ Time Frame: 6-Month Follow-Up (Post-Intervention) ]
  • Positive and Negative Symptom Schedule [ Time Frame: 24-Month Follow-Up (Post-Intervention) ]
  • Manchester Short Assessment of Quality of Life [ Time Frame: Baseline-Day 0 (Pre-intervention) ]
  • Manchester Short Assessment of Quality of Life [ Time Frame: 9-Week Follow-Up (Post-Intervention) ]
  • Manchester Short Assessment of Quality of Life [ Time Frame: 6-Month Follow-Up (Post-Intervention) ]
  • Manchester Short Assessment of Quality of Life [ Time Frame: 24-Month Follow-Up (Post-Intervention) ]

Central Contacts and Locations

Central contacts

Melanie Robles, MD

(780) 983-9773maduples@ualberta.ca

Locations

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada, T5H 3V9

Contacts

Melanie Robles, MD

(780) 983-9773maduples@ualberta.ca

Alberta Hospital Edmonton

Recruiting

Edmonton, Alberta, Canada, T5J 2J7

Contacts

Melanie Robles, MD

(780) 983-9773maduples@ualberta.ca

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Melanie Robles, MD

(780) 983-9773maduples@ualberta.ca

Grey Nuns Community Hospital

Recruiting

Edmonton, Alberta, Canada, T6L 5X8

Contacts

Melanie Robles, MD

maduples@ualberta.camaduples@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

  • Young Adult
  • Psychosis
  • Family Psychoeducation
  • Family Burden
  • Acceptance and Commitment Therapy
  • LEAP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-11-18.