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

NCT07413887 | Recruiting

• 1 other identifier: H-25031805
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preventive Intervention; Mental Health Difficulties

Keywords

Mental Health; Adolescents; Children; Preventive intervention; Sub-clinical symptoms; Randomized controlled trial

Outcome Measures

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.

  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 (6)

• Disordered Eating

  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).

• Emotional dysregulation

  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).

• Anxiety and depression

  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).

• Impulsivity, hyperactivity, and inattention difficulties

  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).

• Obsessive thoughts and compulsive behaviors

  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).

Study Arms (3)

Intervention group

EXPERIMENTAL

Behavioral: 'Signs of Disordered Eating'; Behavioral: 'Signs of Self-Harm'; Behavioral: 'Signs of Internalizing'; Behavioral: 'the Parent Pilots'; Behavioral: 'Take the Control Back'

Control group

ACTIVE COMPARATOR

Behavioral: Active comparator ('Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-harm' and 'Take the Control Back')

Passive Control ('the Parent Pilots')

NO INTERVENTION

For the STIME intervention, 'the Parent Pilots', half of the families will be randomly assigned to the control group and will be enrolled in the intervention after 10 weeks.

Interventions

'Signs of Disordered Eating' BEHAVIORAL

A 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.

Intervention group

'Signs of Self-Harm' BEHAVIORAL

A 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.

Intervention group

'Signs of Internalizing' BEHAVIORAL

A 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.

Intervention group

'the Parent Pilots' BEHAVIORAL

A 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

Intervention group

'Take the Control Back' BEHAVIORAL

A 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.

Intervention group

Active comparator ('Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-harm' and 'Take the Control Back') BEHAVIORAL

For 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.

Control group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 'Signs of Internalizing'
• 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
• 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'

Sponsors & Collaborators

• Center for Clinical Research and Prevention: lead

Study Sites (1)

Center for Clinical Research and Prevention

Frederiksberg, Denmark

RECRUITING

Related Publications (8)

• Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment. 2004;26:41-54.

  BACKGROUND

• Goodman A, Goodman R. Strengths and difficulties questionnaire as a dimensional measure of child mental health. J Am Acad Child Adolesc Psychiatry. 2009 Apr;48(4):400-403. doi: 10.1097/CHI.0b013e3181985068.

  PMID: 19242383 BACKGROUND

• Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.

  PMID: 2684084 BACKGROUND

• Szomlaiski N, Dyrborg J, Rasmussen H, Schumann T, Koch SV, Bilenberg N. Validity and clinical feasibility of the ADHD rating scale (ADHD-RS) A Danish Nationwide Multicenter Study. Acta Paediatr. 2009 Feb;98(2):397-402. doi: 10.1111/j.1651-2227.2008.01025.x. Epub 2008 Sep 4.

  PMID: 18775056 BACKGROUND

• Esbjorn BH, Somhovd MJ, Turnstedt C, Reinholdt-Dunne ML. Assessing the Revised Child Anxiety and Depression Scale (RCADS) in a national sample of Danish youth aged 8-16 years. PLoS One. 2012;7(5):e37339. doi: 10.1371/journal.pone.0037339. Epub 2012 May 23.

  PMID: 22649520 BACKGROUND

• Garfinkel PE, Newman A. The eating attitudes test: twenty-five years later. Eat Weight Disord. 2001 Mar;6(1):1-24. doi: 10.1007/BF03339747.

  PMID: 11300541 BACKGROUND

• Garner DM, Olmsted MP, Bohr Y, Garfinkel PE. The eating attitudes test: psychometric features and clinical correlates. Psychol Med. 1982 Nov;12(4):871-8. doi: 10.1017/s0033291700049163.

  PMID: 6961471 BACKGROUND

• Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

  PMID: 25831962 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Michaela Louise Schiøtz, PhD, cand.scient.san.publ.

CONTACT

+4527333083; michaela.louise.schioetz@regionh.dk

Thea T Amholt, PhD, cand.psych

CONTACT

thea.toft.amholt@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 17, 2026
• Study Start: November 20, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 1, 2026

Record last verified: 2025-10

Locations

DK (1)