The STIME Project: Intersectoral Prevention of Severe Youth Mental Health Difficulties
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorCenter for Clinical Research and Prevention
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
'Signs of Disordered Eating'
BehavioralA manual-based family intervention for children and adolescents (10-17 years) experiencing overwhelming thoughts about food and body image, without meeting criteria for a diagnosed eating disorder. The intervention spans 2-3 months and consists of 5-10 sessions. A STIME therapist from the child's local municipality conducts the sessions with either the parents alone (for children aged 10-12 years) or with the whole family (for children aged 13-17 years). The intervention is based on family-based therapy, emphasizing the parents' role in supporting their child's healthy development. The intervention focuses on presentation of difficulties and change, incorporating elements from Cognitive Behavioral Therapy (CBT), including externalization, validation, and skills training. Practical strategies are applied through homework assignments, goal setting, and self-monitoring.
'Signs of Self-Harm'
BehavioralA manual-based intervention targeting adolescents (12-17 years) with self-harming thoughts and behaviors not requiring specialized psychiatric care. The intervention involves 9 sessions delivered by a trained STIME therapist, with both joint and individual sessions involving the adolescent and parents. Based on CBT, it integrates methods from Acceptance and Commitment Therapy (ACT), Dialectical Behavior Therapy (DBT), and Emotion-Focused Therapy (EFT). Focus areas include developing an understanding of the function and consequences of self-harm, as well as the role and impact of emotions in behavior.
'Signs of Internalizing'
BehavioralA manual-based CBT intervention targeting adolescents (aged 12-17 years) with emotional difficulties consistent with anxiety and subclinical to mild depression, but not requiring treatment in specialized psychiatric care. The intervention begins with an assessment session and includes up to 14 sessions across 9 modules (6 core, 3 optional). Based on CBT, the intervention seeks to enhance the adolescent's understanding of how emotional experiences influence cognitive processes, physiological responses, and behavior. Methods include behavioral experiments, exposure, and emotion regulation strategies. The therapy is grounded in an individual case formulation, which identifies the maintaining factors of the young person's emotional difficulties and sets concrete goals for therapeutic work and change. Sessions involve the adolescent, parents, and relevant network members. Homework is assigned between sessions to support daily-life implementation.
'the Parent Pilots'
BehavioralA manual-based intervention for children and adolescents with subclinical signs of Attention Deficit Hyperactivity Disorder (ADHD). The intervention consists of four group sessions during 6-8 weeks, including parents/caregivers of up to eight children/adolescents, and is conducted by a STIME therapist from the child's local municipality. Individual sessions can be added when considered beneficial based on the family's needs. The intervention is based on family-based therapy and Vygotsky's Zone of Proximal Development and focuses on empowering parents to understand and address their child's behaviors. Between sessions, parents complete manual-structured homework and real-life practice at home. To reinforce progress and ensure consistency across the home and education settings, professionals from the child's educational setting or broader support network may also be involved
'Take the Control Back'
BehavioralA manual-based intervention for children and adolescents (aged 5-17 years) with mild to moderate obsessive thoughts and compulsive behaviors, but not requiring treatment in specialized psychiatric care. The intervention begins with an assessment session and includes a minimum of eight sessions. Grounded in family-based cognitive behavioral therapy, it combines goal-focused work, psychoeducation, exposure, response, and prevention as the main therapeutic components. The primary aim is to support the child/adolescent in being exposed to situations that may trigger obsessive thoughts and to refrain from allowing these thoughts to dictate behavior. Sessions involve the child/adolescent and their parents. To support the process, it is possible to involve professionals from the learning environment and the child/adolescent's wider network. Homework assignments are given between sessions for both the child/adolescent and their parents, to support practice in daily life.
Active comparator ('Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-harm' and 'Take the Control Back')
BehavioralFor the STIME-interventions 'Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-harm', and 'Take the control back', children and adolescents allocated to the control group will receive 3-4 individual online sessions with a psychologist over 10 weeks while waiting to start the intervention. The number of sessions depends on the presenting concern: up to three sessions for the interventions 'Signs of Internalizing', 'Signs of Self-harm', and 'Take the control back', and up to four sessions for the intervention 'Signs of Disordered Eating'. Sessions may involve the child/adolescent alone, the parents alone, or both together. Psychologists providing the sessions have experience working with all target groups, but have not received training in the STIME program. They will be given freedom to use less than the maximum number of sessions and to choose their therapeutic approach to mimic the variability of management as usual.
Treatment groups
1,200 Participants
are divided into 3 treatment groupsGroup A: Intervention groupExperimental treatment 5 interventions
Group B: Control groupActive comparator 1 intervention
Group C: Passive Control ('the Parent Pilots')No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Well-being
WHO-5 Well-being Index (Topp et al., 2015). The World Health Organization Five Well-Being Index, minimum score of 0 and maximum score 25, where higher scores indicate better mental well-being.
Time frame
For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).Secondary outcomes
1
Disordered Eating
The study will assess signs of disordered eating among participants enrolled in the STIME intervention 'Signs of Disordered Eating', using the Eating Attitudes Test (EAT-26) (Garfinkel \& Newman, 2001; Garner et al., 1982). The Eating Attitudes Test-26 (EAT-26) is the Eating Attitudes Test, 26-item version, a self-report screening measure for disordered eating attitudes and behaviors with a total score that can range from 0 to 78, where higher scores indicate greater eating-related concern and risk.
Time frame
For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).2
Emotional dysregulation
The study will assess emotional dysregulation among participants enrolled in the STIME intervention 'Signs of Self-harm', using the Difficulties in Emotion Regulation Scale (DERS-16) (Gratz \& Roemer, 2004). The Difficulties in Emotion Regulation Scale - 16-item version (DERS-16) is a brief self-report measure of overall difficulties in emotion regulation with 16 items rated on a 5-point scale yielding a total score that ranges from 16 to 80, where higher scores indicate greater difficulties in emotion regulation.
Time frame
For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).3
Anxiety and depression
The study will assess signs of anxiety and depression among participants enrolled in the STIME intervention, 'Signs of Internalizing', using the Revised Child Anxiety and Depression Scale (RCADS) (Esbjørn et al., 2012). The Revised Child Anxiety and Depression Scale (RCADS) is the Revised Child Anxiety and Depression Scale self-report questionnaire (usually 47 items) that assesses DSM-defined anxiety and depression symptoms with item scores from 0 ("Never") to 3 ("Always"), yielding subscale and total raw scores that can range from 0 (no symptoms) up to the maximum possible summed raw score (e.g., 0-141 for the full 47-item version) where higher scores indicate greater anxiety and/or depressive symptom severity.
Time frame
For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).4
Impulsivity, hyperactivity, and inattention difficulties
The study will assess signs of impulsivity, hyperactivity, and inattention difficulties among participants enrolled in the STIME intervention, 'The Parent Pilots', using the Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) (Szomlaiski et al., 2009). The Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) is the ADHD Rating Scale (often aligned with DSM criteria in its current ADHD-RS-5/IV versions) consisting of 18 items scored from 0 ("never/rarely") to 3 ("very often") with a total raw score range of 0 to 54, where higher scores indicate greater severity of ADHD symptoms
Time frame
For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).Sponsors and contacts
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Source ClinicalTrials.gov