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

Recruiting now · Not applicable

Conditions studied: Preventive Intervention, Mental Health Difficulties

In brief

This randomized controlled trial aims to evaluate the effectiveness of participation in five different STIME (Strengthened Cross-Sectoral Initiative for Children and Young People's Mental Health) interventions: 'Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-Harm', 'Take the Control Back', and 'The Parent Pilots'. The hypothesis is that participation in one of these interventions will be more effective than Management As Usual (MAU). Each intervention consists of three core components: early identification and screening, therapy based on evidence-informed manuals, and support within the child's learning environment.

Key facts

Study ID

NCT07413887

Run by

Center for Clinical Research and Prevention

People needed

1200

Starts

2025-11-20

Expected to finish

2028-02-01

Last updated by the study team

2026-06-01

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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'

Where it is running

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

Full record on ClinicalTrials.gov

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