Preventive InterventionSTIMENCT07413887
The STIME Project: Intersectoral Prevention of Severe Youth Mental Health Difficulties
A study testing 'Signs of Disordered Eating', 'Signs of Self-Harm' and 'Signs of Internalizing' in people with Preventive Intervention and Mental Health Difficulties, run by Center for Clinical Research and Prevention at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Preventive Intervention, Mental Health Difficulties
- What is being tested?
- 'Signs of Disordered Eating', 'Signs of Self-Harm' and 'Signs of Internalizing'
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Nov 2025to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Children and adolescents aged 10-17 years
Show all 24Show fewer
- 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
- 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
- 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
- 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
Who cannot join
- 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
Show all 36Show fewer
- Increased or acute suicide risk
- Presence of self-harm or symptoms of disordered eating
- 'Signs of Disordered Eating'
- 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'
- 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'
- 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'
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michaela Louise Schiøtz, PhD, cand.scient.san.publ. contact
Thea T Amholt, PhD, cand.psych contact
Denmark1 site, 1 recruiting
- Recruiting
Center for Clinical Research and Prevention
Frederiksberg
Michaela Schiøtz, +45 20 26 63 44, ckff-stime.bispebjerg-frederiksberg-hospitaler@regionh.dk
About this study
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.
Read the detailed description
This project consists of five separate randomized controlled trials, each designed to evaluate the effectiveness of one of the five STIME interventions.
Mental health difficulties in childhood can have wide-ranging negative consequences for a child's development, learning, education, physical and psychological health in adulthood, family formation, and later attachment to the labor market. Thus, mental health difficulties among children and adolescents constitute a significant public health issue that requires immediate cross-sectoral action.
Existing research points to effective strategies for the prevention of progression of mental health difficulties to mental health problems that require psychiatric treatment. However, we still know relatively little about whether and how interventions work in the real-life contexts in which they are intended to function. In particular, there is a lack of research on implementation in practice-an evidence gap that may be bridged by integrating systematic evaluation components into existing prevention programs such as STIME.
STIME is a collaboration between municipalities and the regional child and adolescent psychiatry, aiming to prevent the progression of mental health difficulties among children and adolescents aged 3-17 years, before specialized treatment is required. The interventions target a subclinical population-that is, children and adolescents who show signs of mental health difficulties, such as anxiety, disordered eating, or self-harm, but who do not meet the diagnostic criterias for a mental disorder. As part of the collaboration, regional mental health services are responsible for training municipal psychologists, while the municipalities are in charge of delivering the interventions.
Although a pilot evaluation indicates that the STIME interventions are promising, there is a need for a rigorous examination of their effectiveness. The present study will therefore investigate the effectiveness of five STIME interventions.
The study will be conducted as five separate randomized controlled trials. Participants eligible for partaking in 'Signs of Disordered Eating' will be allocated either to the intervention or MAU, involving a maximum of four online 45 min sessions over a period of ten weeks with a psychologist, upon which the 'Signs of Disordered Eating' intervention will be offered. Participants eligible for participation in 'Signs of Self-harm', 'Signs of Internalizing' or 'Take the Control Back' will be allocated either to the intervention or MAU, involving a maximum of three online 45 min sessions over a period of ten weeks with a psychologist, upon which the relevant intervention will be offered. The control group psychologists will have previous experience with the appropriate populations, but no prior knowledge or training in the STIME concepts.
For 'the Parent Pilots' intervention, parents will be randomized to either commencement of the intervention within the first group or the following group, which will commence when the first group finishes after ten weeks. As such, this will be a passive waitlist control group.
The primary aim is to determine whether participation in a STIME intervention results in greater improvements in mental health difficulties and everyday functioning compared to the control group. Effectiveness will be assessed using validated measures of wellbeing (primary outcome of interest) and functionality indicators relevant to each intervention's mental health difficulty (secondary outcome of interest). Outcomes will be measured at baseline (T0), immediately post intervention (T1), and six months post baseline (T2).
- Being tested
- 'Signs of Disordered Eating', 'Signs of Self-Harm', 'Signs of Internalizing', 'the Parent Pilots', 'Take the Control Back'
- Keywords
- Mental Health, Adolescents, Children, Preventive intervention, Sub-clinical symptoms, Randomized controlled trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Signs of Disordered Eating'Behavioural
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.
'Signs of Self-Harm'Behavioural
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.
'Signs of Internalizing'Behavioural
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.
'the Parent Pilots'Behavioural
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
'Take the Control Back'Behavioural
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.
Active comparator ('Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-harm' and 'Take the Control Back')Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: 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 | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
The study will assess signs of obsessive thoughts and compulsive behaviours among participants enrolled in the STIME intervention 'Take the control back', using an adapted and translated version of the Yale-Brown Obsessive Compulsive Scale (Goodman WK et al., 1989) (currently undergoing validation in a Danish youth population).
Measured: 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).
Well-being SDQ
SDQ Impact Scale (Goodman, A. \& Goodman, R., 2009). Strengths and Difficulties Questionnaire (SDQ) Impact Scale supplemental to the SDQ is the SDQ Impact Supplement assessing overall distress and impairment, with an impact score that ranges from 0 to 10 for parent- and self-report (and 0 to 6 for teacher report), where higher scores indicate greater impact of difficulties on the child's life
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start20 Nov 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Preventive InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Research and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413887
- Sponsor's protocol ID
- H-25031805
- Acronym
- STIME
- Status last verified
- Oct 2025
- First submitted
- 4 Feb 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
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.
PubMed 19242383Goodman 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.
PubMed 2684084Szomlaiski 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.
PubMed 18775056Esbjorn 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.
PubMed 22649520Garfinkel PE, Newman A. The eating attitudes test: twenty-five years later. Eat Weight Disord. 2001 Mar;6(1):1-24. doi: 10.1007/BF03339747.
PubMed 11300541Garner 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.
PubMed 6961471Topp 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.
PubMed 25831962
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STIME Project: Intersectoral Prevention of Severe Youth Mental Health Difficulties
- ClinicalTrials.gov ID
- NCT07413887
- Acronym / sponsor ID
- STIME / H-25031805
- Keywords
- Mental Health, Adolescents, Children, Preventive intervention, Sub-clinical symptoms, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Center for Clinical Research and PreventionResearch network
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project consists of five separate randomized controlled trials, each designed to evaluate the effectiveness of one of the five STIME interventions.
Mental health difficulties in childhood can have wide-ranging negative consequences for a child's development, learning, education, physical and psychological health in adulthood, family formation, and later attachment to the labor market. Thus, mental health difficulties among children and adolescents constitute a significant public health issue that requires immediate cross-sectoral action.
Existing research points to effective strategies for the prevention of progression of mental health difficulties to mental health problems that require psychiatric treatment. However, we still know relatively little about whether and how interventions work in the real-life contexts in which they are intended to function. In particular, there is a lack of research on implementation in practice-an evidence gap that may be bridged by integrating systematic evaluation components into existing prevention programs such as STIME.
STIME is a collaboration between municipalities and the regional child and adolescent psychiatry, aiming to prevent the progression of mental health difficulties among children and adolescents aged 3-17 years, before specialized treatment is required. The interventions target a subclinical population-that is, children and adolescents who show signs of mental health difficulties, such as anxiety, disordered eating, or self-harm, but who do not meet the diagnostic criterias for a mental disorder. As part of the collaboration, regional mental health services are responsible for training municipal psychologists, while the municipalities are in charge of delivering the interventions.
Although a pilot evaluation indicates that the STIME interventions are promising, there is a need for a rigorous examination of their effectiveness. The present study will therefore investigate the effectiveness of five STIME interventions.
The study will be conducted as five separate randomized controlled trials. Participants eligible for partaking in 'Signs of Disordered Eating' will be allocated either to the intervention or MAU, involving a maximum of four online 45 min sessions over a period of ten weeks with a psychologist, upon which the 'Signs of Disordered Eating' intervention will be offered. Participants eligible for participation in 'Signs of Self-harm', 'Signs of Internalizing' or 'Take the Control Back' will be allocated either to the intervention or MAU, involving a maximum of three online 45 min sessions over a period of ten weeks with a psychologist, upon which the relevant intervention will be offered. The control group psychologists will have previous experience with the appropriate populations, but no prior knowledge or training in the STIME concepts.
For 'the Parent Pilots' intervention, parents will be randomized to either commencement of the intervention within the first group or the following group, which will commence when the first group finishes after ten weeks. As such, this will be a passive waitlist control group.
The primary aim is to determine whether participation in a STIME intervention results in greater improvements in mental health difficulties and everyday functioning compared to the control group. Effectiveness will be assessed using validated measures of wellbeing (primary outcome of interest) and functionality indicators relevant to each intervention's mental health difficulty (secondary outcome of interest). Outcomes will be measured at baseline (T0), immediately post intervention (T1), and six months post baseline (T2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Signs of Disordered Eating'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. | Behavioural | Intervention group |
| 'Signs of Self-Harm'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. | Behavioural | Intervention group |
| 'Signs of Internalizing'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. | Behavioural | Intervention group |
| 'the Parent Pilots'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 | Behavioural | Intervention group |
| 'Take the Control Back'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. | Behavioural | Intervention group |
| Active comparator ('Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-harm' and 'Take the Control Back')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. | Behavioural | Control group |
Primary outcome
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).
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.
6 secondary outcomes
Disordered Eating
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).
Emotional dysregulation
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).
Anxiety and depression
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).
Impulsivity, hyperactivity, and inattention difficulties
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).
Obsessive thoughts and compulsive behaviors
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).
Well-being SDQ
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- BackgroundGratz 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: PubMed 19242383Goodman 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.
- Background: PubMed 2684084Goodman 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.
- Background: PubMed 18775056Szomlaiski 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.
- Background: PubMed 22649520Esbjorn 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.
- Background: PubMed 11300541Garfinkel PE, Newman A. The eating attitudes test: twenty-five years later. Eat Weight Disord. 2001 Mar;6(1):1-24. doi: 10.1007/BF03339747.
- Background: PubMed 6961471Garner 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.
- Background: PubMed 25831962Topp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michaela Louise Schiøtz, PhD, cand.scient.san.publ. contact
Thea T Amholt, PhD, cand.psych contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Signs of Disordered Eating', 'Signs of Self-Harm' and 'Signs of Internalizing' in people with Preventive Intervention and Mental Health Difficulties, run by Center for Clinical Research and Prevention at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaela Louise Schiøtz, PhD, cand.scient.san.publ. (+4527333083, michaela.louise.schioetz@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07413887, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.