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

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое '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-base
• Поведенческое '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 understan
• Поведенческое '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 resp
• Поведенческое '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 o
• Поведенческое '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
• Поведенческое 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 fo

Первичные конечные точки

• Well-being [Срок оценки: 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).]

Вторичные конечные точки (6)

• Disordered Eating [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Критерии участия

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

'Signs of Internalizing'

Критерии включения

• 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

Критерии исключения

• 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'

Критерии включения

• 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

Критерии исключения

• 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'

Критерии включения

• 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

Критерии исключения

• 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'

Критерии включения

• 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

Критерии исключения

• 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'

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Дания · 1 центр

• Center for Clinical Research and Prevention — Frederiksberg

Публикации

• 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. PMID 19242383
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07413887 · H-25031805

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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