STIME: Preventing serious mental health problems in children and teens

The STIME Project: Intersectoral Prevention of Severe Youth Mental Health Difficulties

This project will test five STIME prevention programs to see if they help children and adolescents aged 3–17 with early signs of mental health difficulties stay well compared with usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 3 Years to 17 Years
• Sex: All
• Sponsor: Center for Clinical Research and Prevention (network)
• Locations: 1 site (Frederiksberg)
• Trial ID: NCT07413887 on ClinicalTrials.gov

What this trial studies

The project comprises five separate randomized controlled trials, each testing one of the STIME interventions (Signs of Disordered Eating, Signs of Internalizing, Signs of Self-Harm, Take the Control Back, and The Parent Pilots) against Management As Usual. Each intervention combines early identification and screening, therapy delivered from evidence-informed manuals, and support within the child’s learning environment. Trials target a subclinical population of children and adolescents before specialized psychiatric treatment is required and use narrow, intervention-specific inclusion and exclusion criteria. STIME is implemented in collaboration between municipalities and regional child and adolescent psychiatry to measure effectiveness in real-world settings.

Who should consider this trial

Good fit: Children and adolescents roughly aged 3–17 who show early, subclinical signs of anxiety, disordered eating, self-harm risk, or related mental health difficulties and whose families and local schools are willing to participate are ideal candidates.

Not a fit: Children or adolescents who already meet criteria for moderate to severe psychiatric disorders, have major functional impairment, low cognitive functioning, or lack necessary family/school support are unlikely to benefit from these prevention programs.

Why it matters

Potential benefit: If successful, these programs could reduce progression to more severe psychiatric problems and improve daily functioning, school engagement, and long-term outcomes for affected children and families.

How similar studies have performed: Previous prevention programs have shown promise in reducing progression of youth mental health problems, but evidence on how well such programs work when implemented across real-world municipal and clinical settings is still limited.

Eligibility criteria

Each of the interventions has elaborate and narrowly defined inclusion and exclusion criteria. These are listed below for each intervention.

'Signs of Internalizing'

Inclusion criteria

* Adolescents aged 12-17 years
* Mild to moderate impairment in daily functioning (e.g., reduced engagement in school, social life, or leisure activities compared to before symptoms)
* Adolescents with well-managed ADHD or autism may be included if they demonstrate sufficient mentalizing abilities and can benefit from the intervention with parental support
* Presence of both anxiety and depressive symptoms, neither of which dominates or meets full diagnostic criteria
* The family is motivated to participate

Exclusion criteria

* Symptoms of moderate to severe depression
* Presence of OCD, PTSD, agoraphobia, panic disorder, or other psychiatric conditions
* Low cognitive functioning
* Moderate to severe functional impairment (e.g., school dropout, extreme social withdrawal, daily reliance on adult support, lack of motivation for treatment)
* Recent unsuccessful psychological treatment
* Primary problems related to family dynamics or a highly burdened family situation
* Increased or acute suicide risk
* Presence of self-harm or symptoms of disordered eating

'Signs of Disordered Eating'

Inclusion criteria

* Children and adolescents aged 10-17 years
* High body dissatisfaction, preoccupation with food and/or body image, and/or early behavioral signs of an eating disorder
* Stable physical condition, manageable in consultation with the adolescent's general practitioner
* Able to consume food with guidance and support
* The family is motivated to participate

Exclusion criteria

* Previous treatment for an eating disorder
* Symptoms meeting criteria for specialized psychiatric treatment
* Low cognitive functioning
* Significant weight loss
* Solely restrictive or selective eating without other eating disorder symptoms
* Severe comorbidity
* Increased or acute suicide risk
* Eating difficulties solely related to lifestyle factors

'Signs of Self-Harm'

Inclusion criteria

* Adolescents aged 12-17 years
* Current thoughts of self-harm
* At least one episode of direct (non-suicidal) self-harm within the past three months
* The family is motivated to participate

Exclusion criteria

* Increased suicide risk
* Psychiatric disorder requiring further assessment or not adequately treated
* Low cognitive functioning
* Self-harm only in socially accepted contexts (e.g., piercings or tattoos)
* Only indirect self-harm (e.g., excessive substance use)
* Only self-harm by proxy (involving another person)

'Take the Control Back'

Inclusion criteria

* Children and adolescents aged 5-17 years
* Experiencing obsessive thoughts and/or compulsive behaviors of mild to moderate severity
* Experiencing self-perceived distress related to obsessive thoughts and/or compulsive behaviors
* Experiencing obsessive thoughts as egodystonic, and thus aware that they are excessive (for the youngest participants, this criterion may be waived in cases of limited insight)
* Functioning is impaired by obsessive thoughts and/or behaviors, e.g., reduced school functioning, social difficulties, or impaired functioning at home
* The family is motivated to participate

Exclusion criteria

* Symptoms meeting criteria for specialized psychiatric treatment
* Has another psychiatric disorder that requires assessment or is not adequately managed
* Has difficulties other than obsessive thoughts and behaviors that currently constitute the primary burden, and which must be addressed first
* Has previously received OCD treatment within psychiatric care (may be offered STIME if assessed but not treated due to mild severity)
* Has an increased or acute risk of suicide
* Has low functioning for other reasons, e.g., significantly reduced cognitive functioning

'the Parent Pilots'

Inclusion criteria

* Parents of children aged 3-10 years who experience developmentally inappropriate difficulties with restlessness, hyperactivity, attention, and/or impulsivity
* The symptoms must be present at home as a minimum, but may also occur across settings such as home, daycare, and school
* The child's difficulties must be significant enough to affect overall daily functioning
* The parents are motivated to participate

Exclusion Criteria:

* Symptoms of attention difficulties that require psychiatric treatment
* Presence of another psychiatric disorder that requires treatment
* Previous treatment for ADHD within the psychiatric system
* Low level of functioning due to other causes, such as significantly reduced cognitive functioning

Where this trial is running

Frederiksberg

• Center for Clinical Research and Prevention — Frederiksberg, Denmark (RECRUITING)

Study contacts

• Study coordinator: Michaela Louise Schiøtz, PhD, cand.scient.san.publ.

Conditions: Preventive Intervention, Mental Health Difficulties, Mental Health, Adolescents, Children, Preventive intervention, Sub-clinical symptoms, Randomized controlled trial