Prevention of mental health-related impairment in children with high risk of developing mental disorders. Mental and Behavioural Disorders
Conditions
Interventions
This is a single-centre, two-arm, parallel-assignment, superiority RCT with 1:1 allocation to transdiagnostic mental-health prevention or monitored usual care, with masked outcome assessors.
Interven
Sponsors
Lund University
Eligibility
Sex/Gender
All
Age
8 Years to 9 Years
Inclusion criteria
Inclusion criteria: 1. Child age: Child must have turned or turn 9 during the current calendar year (assessed by year of birth). 2. Two biological parents with a lifetime history of mental illness: Parental mental illness is assessed in two steps. At screening, a semi-structured interview explores the following areas: (i) prior psychiatric or mental health treatment, (ii) mental disorder diagnosis by a health professional, (iii) inpatient psychiatric care, (iv) psychiatric medication or psychological treatment for a mental disorder, and (v) mental health-related sick leave. If only one parent is available, this parent provides information about the other parent. At baseline, each participating biological parent is invited to a diagnostic interview. Lifetime parental mental disorder status is based on the best available information from both steps. 3. Language ability: Child and at least one biological parent must be able to read, write, and communicate in Swedish (per parent report). 4. Assessment participation: Child and at least one biological parent must be able to attend yearly in-person assessments at the research unit (per parent report). 5. Digital access: Family must have access to the internet and a smartphone or touchscreen tablet (per parent report). 6. Willingness to participate in parent-focused prevention: At least one biological parent must express willingness to engage in a long-term digital prevention program (per parent report after parental mental disorder status has been determined).
Exclusion criteria
Exclusion criteria: 1. Safety or welfare risks: Any child- or parent-related condition that would make participation unsafe or unethical, such as acute suicidality, uncontrolled neurological illness, confirmed ongoing abuse investigations, or current need for inpatient psychiatric/medical care. 2. Practical barriers to study adherence: Circumstances likely to disrupt required visits, follow-ups, or digital access, such as expected relocation outside the region, unresolved custody disputes, lack of reliable internet/smartphone access, or simultaneous participation in another long-term psychosocial intervention trial. 3. Ability to use the program: Limitations that prevent meaningful engagement with the digital intervention, such as intellectual disability or major sensory impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child mental health-related functional impairment measured using the interview version of the Uppsala Functional Impairment in Daily life (UFID) at 36 months post-randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Child mental health-related functional impairment measured using the interview version of the UFID at 12 and 24 months post-randomization 2. Presence of any child mental disorder, any DSM-5 diagnostic category (anxiety disorders, depressive disorders, obsessive-compulsive and related disorders, trauma- and stressor-related disorders, eating disorders, externalizing disorders, and neurodevelopmental disorders), and count of mental disorders, measured using the DIAMOND-KID interview at 12, 24, and 36 months post-randomization 3. Overall child psychosocial functioning measured using the Children’s Global Assessment Scale (CGAS) at 12, 24, and 36 months post-randomization 4. Overall severity of child mental health problems measured using the Clinical Global Impressions-Severity (CGI-S) scale at 12, 24, and 36 months post-randomization 5. Child anxiety and depression symptoms measured using the child-reported 30-item version of the Revised Child Anxiety and Depression Scale (RCADS-30) at 4, 8, 12, 16, 20, 24, 28, 32, and 36 months 6. Child anxiety and depression symptoms measured using the parent-reported 30-item version of the RCADS-30 at 4, 8, 12, 16, 20, 24, 28, 32, and 36 months 7. Child externalizing symptoms measured using the parent-rated Conduct Problems Scale at 4, 8, 12, 16, 20, 24, 28, 32, and 36 months 8. Child irritability measured using the child-reported Inventory of Depression and Anxiety Symptoms (IDAS-II) Irritability scale at 4, 8, 12, 16, 20, 24, 28, 32, and 36 months 9. Child irritability measured using the parent-reported IDAS-II Irritability scale at 4, 8, 12, 16, 20, 24, 28, 32, and 36 months 10. Child neurodevelopmental symptoms measured using the Concentrate and Stay Still and Communication scales of the parent-reported Extended Strengths and Weaknesses Assessment of Normal Behavior – General Instrument at 4, 8, 12, 16, 20, 24, 28, 32, and 36 months 11. Child emotional resilience measured using the child-reported Behavioral, Emotional, and | — |
Countries
Sweden
Contacts
Public ContactMatti Cervin
Outcome results
None listed