Skills for Wellness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-21
SponsorNova Scotia Health Authority
About this trial
Severe mental illness such as schizophrenia and mood disorders typically develops at a young age and can cause life-long disability. Currently available treatments cannot cure severe mental illness. This makes it important to find ways to prevent severe mental illness in young people before it has a chance to develop. This research study will pilot a new preventive intervention for young people who are at high risk of developing severe mental illness. The investigators will target early preceding factors (the 'antecedents') to severe mental illness which includes anxiety, unusual hearing and visual experiences, the loss of previously acquired abilities, and sudden and unpredictable changes in mood. These antecedents strongly predict an increased risk of developing severe mental illness. They are often impairing and distressing to the individual but can be improved with self-management skills and parent training, and they are present in the individual years before the onset of severe mental illness which makes them an ideal target for early intervention. The goal is to intervene early enough in the young person's life that severe mental illness can be prevented, hopefully leading to a happy, healthy and productive adulthood. The investigators want to test the acceptability and short-term efficacy of this new preventive intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
FORBOW (Families Overcoming Risks and Building Opportunities for Well-Being) participant between 9-21 years old
Meet criteria for one or more antecedents (psychotic like experience, basic symptoms, anxiety or affective lability)
Disqualifiers
Diagnosis of severe mental illness (schizophrenia, other psychotic disorder, bipolar disorder, severe major depressive disorder)
More than 3 sessions of structured psychological therapy in the past 12 months
Insufficient understanding of the English language to benefit from the intervention
Trial design
Design model
Parallel
Treatments tested in this trial
maCBT
BehavioralMultimodal Antecedent-focussed Cognitive-behavioural Training (maCBT) is an individual manualized psychological intervention. It follows an integrated model focussed on normalisation of the unusual experiences, their re-appraisal, exploring helpfulness of current coping, and developing a repertoire of strategies to decrease the impact of these experiences on the young person's life. The maCBT follows a manual describing obligatory and optional therapeutic elements, proposed list of modules, outline of a therapeutic session, and the integrated cognitive model. The intervention will be delivered in 8 to 16 one-hour sessions in an individual format. Sessions will be initially weekly, and then spaced out to once every two weeks in the latter stages of the intervention.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: maCBTExperimental treatment 1 intervention
Group B: ComparisonNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Early antecedents to severe mental illness
Presence of any one (or more) of four early antecedents that may indicate risk for developing severe mental illness (psychotic-like experiences, basic symptoms, anxiety and affective lability). psychotic-like experiences - presence of one or more definite clinician-confirmed psychotic symptoms on Funny Feelings instrument. basic symptoms = presence of COGDIS (Cognitive Disturbances) or COPER (Cognitive-perceptive basic symptoms) high risk profile on the Schizophrenia Proneness Instrument - Child and Youth version (SPI-CY) anxiety = diagnosis of an anxiety disorder on K-SADS (Kiddie-Schedule for Affective Disorders and Schizophrenia) interview or score above the high specificity cutoff (30 or higher) on the SCARED (Screen for Child Anxiety Related Disorders) questionnaire (self or parent report) affective lability = score of 1 standard deviation or more above general population on the affective lability scales (self- or parent report)
Time frame
4-6 months after the end of the interventionSecondary outcomes
1
Severe mental illness (long-term outcome)
Diagnosis of major mood (major depressive disorder, bipolar disorder) or psychotic disorder (schizophrenia, schizoaffective, schizophreniform, or delusional disorder)on K-SADS or SCID (Structured Clinical Interview for DSM) diagnostic interviews on any follow-up visit.
Time frame
Annual follow-ups over 3, 5, 7 and 10 years2
Distress associated with unusual experiences
Distress ratings of the Funny Feelings questionnaire.
Time frame
4-6 months, 1, 2, 3, and 5 years post intervention3
Functioning
General, social and role functioning scales; employment status.
Time frame
4-6 months, 1, 2, 3, 5 , 7 and 10 years post intervention.4
psychotic-like experiences
presence of one or more definite clinician-confirmed psychotic symptoms on the Funny Feelings instrument
Time frame
4-6 months, 1, 2, 3, and 5 years post interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nova Scotia Health Authority
Lead sponsor
Nova Scotia Health Research Foundation
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov