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Набор скоро начнётся NCT07366580

TOUCHminds: Help-seeking in Adolescents With Anxiety

Без фазы С лечением Anxiety Symptoms Anxiety Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: TOUCHminds - Web-Based Intervention.
Кому может быть актуально
Состояния в реестре: Anxiety Symptoms, Anxiety Disorders. Базовые параметры: 15 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Португалия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

TOUCHMinds: An RCT on Help-seeking for Adolescent Anxiety

Обзор

Adolescents frequently experience clinical and subclinical anxiety symptoms, yet many avoid seeking professional help. While universal interventions exist to promote help-seeking, targeted programs for adolescents with elevated anxiety symptoms remain scarce. Therefore, accessible and tailored strategies are needed to effectively promote help-seeking among this group. TOUCHminds is a web-based intervention designed to enhance help-seeking among adolescents with clinical or subclinical anxiety. The program consists of six self-guided modules featuring interactive activities (e.g., images, videos, simulation activities, and audio recordings), combined with three synchronous sessions led by a psychologist via videoconference. The intervention explicitly targets precursors of help-seeking, including mental health literacy, mental health stigma, self-compassion, readiness to change, and stage of change. This research project comprises two studies. Study I, a feasibility study involving 10 adolescents aged 15 to 17, will assess recruitment procedures, dropout rates, usage patterns, therapist fidelity, acceptability, usability, satisfaction, and preliminary effects. Study II, a randomized controlled trial (RCT), intends to include 96 adolescents randomly assigned to four groups: clinical intervention, clinical control, subclinical intervention, and subclinical control. Clinical participants are those who meet diagnostic criteria for one or more anxiety disorders, whereas subclinical participants present high self-reported anxiety but no mental disorder diagnosis. Intervention effects will based on self-report assessments conducted at pre-intervention, post-intervention (9 weeks later), and at 3-month follow-up. This research will provide evidence regarding the suitability and effectiveness of TOUCHminds in promoting help-seeking among adolescents experiencing different levels of anxiety symptoms. Findings will contribute to the field of empirically validated web-based interventions tailored specifically for adolescents.

Подробное описание

Nearly 14% of adolescents experience mental health disorders, many of which remain unrecognized and untreated. Anxiety disorders, affecting approximately 5.5% of adolescents aged 15-19, commonly emerge during childhood or adolescence and are linked to anxiety persisting into adulthood, increased risk of other disorders such as substance abuse and major depressive disorder, and significant impairments across life domains, including reduced quality of life and lower educational attainment. Despite these risks, adolescents often show reluctance to seek help, particularly when symptoms are more severe. Barriers to help-seeking include lack of mental health literacy, which prevents from recognizing the severity of one's condition or from identifying it as a mental health issue, and mental health stigma, leading adolescents to conceal their struggles. Interventions often overlook additional barriers such as shame and low self-confidence. Promising facilitators for overcoming these barriers include fostering self-compassion, involving kindness and understanding towards oneself in difficult situations, and promoting well-being across emotional, psychological, and social dimensions. Additionally, enhancing readiness to change and utilizing motivational interviewing techniques, based on the transtheoretical model stages of change, may further facilitate adolescents' engagement in help-seeking behaviors by increasing motivation and managing ambivalence.

Interventions aimed at promoting adolescent help-seeking have typically been universal, potentially limiting their effectiveness for adolescents with clinical or subclinical symptoms who require more targeted support to recognize their need for professional help. Selective and indicated interventions, specifically tailored to these adolescents, have shown greater long-term efficacy but remain underexplored. Most existing programs primarily address barriers such as stigma and mental health literacy. Web-based interventions, particularly those that are multicomponent (e.g., psychoeducation, quizzes, vignettes) and involve minimal professional contact, have been suggested as effective in overcoming barriers such as stigma and low mental health literacy. However, key facilitators such as self-compassion, readiness for change and motivational interviewing techniques are largely absent from existing interventions, even though web-based interventions targeting self-compassion or integrating motivational interviewing appear to enhance their well-being and adolescents' engagement with mental health care.

TOUCHminds targets these gaps through a multicomponent web-based intervention, combined with synchronous psychologist-led sessions, addressing both help-seeking intentions and behaviors. The investigators will also assess changes in post-intervention and during follow-up, as the stability of change has been rarely explored in previous works targeting help-seeking. Additionally, the investigators aim to include adolescents with subclinical symptoms, often overlooked in existing programs. Finally, mechanisms of change remain unclear, particularly whether reduced stigma or improved mental health literacy drive help-seeking. Study I (feasibility) will assess recruitment procedures, dropout rates, usage patterns, therapist fidelity, acceptability, usability, satisfaction, and preliminary effects on help-seeking, in the precursors (mental health literacy, stigma, self-compassion, stage of change, readiness for change) of help-seeking and in well-being. Study II (RCT) will compare intervention groups (clinical, subclinical) with control groups across three moments. Expected results include increases in help-seeking intentions (both intervention groups), behaviors (intervention group clinical), precursors, and well-being, and changes in those precursors will explain shifts in intentions/behaviors over time.

All procedures will be authorized by the Directorate-General for Education, the General Data Protection Regulation of the University of Aveiro, and the University of Aveiro Ethics Committee for Clinical Research. Adolescents will be recruited in portuguese schools; adolescents and their guardians will receive full study information, confidentiality assurances, and will provide parental consent and adolescent assent, with no incentives. Screening comprises the State-Trait Anxiety Inventory for Children (STAIC) and a sociodemographic form; participants scoring 1 standard deviation above the mean will be invited to a Mini-KID diagnostic interview via videoconference to confirm inclusion/exclusion (i.e., include primary anxiety disorder and no diagnosis; exclude psychotic symptoms and suicidal risk). After completing the Mini-KID interview, the psychologist will complete the Clinical Global Impression - Severity scale (CGI-S) to provide a baseline assessment of psychopathology severity. Eligible participants will then be emailed to register to the platform, while adolescents outside criteria (e.g., psychotic symptoms, suicidal risk, other primary disorders) will be referred to school psychology services.

Вмешательства

  • Поведенческое TOUCHminds - Web-Based Intervention
    A web-based intervention designed to promote help-seeking in adolescents with clinical or subclinical anxiety symptoms. The program combines six self-guided online modules with three individual videoconference sessions with a trained psychologist. It integrates core components from Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Compassion-Focused Therapy (CFT), Motivational Interviewing, and the Transtheoretical Model of Change. The intervention is tailored to the d

Первичные конечные точки

  • General Help-Seeking Questionnaire (GHSQ). [Срок оценки: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).]
  • Adolescent Help-Seeking Behavior Scale (AHSBS). [Срок оценки: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).]
Вторичные конечные точки (5)
  • Adolescents' Mental Health Knowledge (AMHK). [Срок оценки: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).]
  • Peer Mental Health Stigmatization Scale (PMHSS). [Срок оценки: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).]
  • Self-Compassion Scale for Adolescents (SCS-A). [Срок оценки: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).]
  • University of Rhode Island Change Assessment (URICA). [Срок оценки: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).]
  • Mental Health Continuum - Short Form - for youth (MHC-SF). [Срок оценки: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).]

Критерии участия

Критерии включения

For all experimental and control groups, the inclusion criteria are:

  • Aged between 15 and 17 years old at the time of screening;
  • Fluent in Portuguese;
  • Have access to a smartphone, tablet, or computer;
  • Have reliable internet access.

Clinical Groups Specific:

  • Must meet criteria for a primary diagnosis of at least one anxiety disorder, as assessed by the MINI-KID (Rijo et al., 2016).

Subclinical Groups Specific:

  • Must not meet diagnostic criteria for any mental health disorder, as assessed by the MINI-KID (Rijo et al., 2016).

Критерии исключения

Exclusion criteria for all experimental and all control groups are:

  • Psychotic symptoms or suicidal risk as assessed via the Mini-Kid (Rijo et al., 2016);
  • Being part of the special needs teaching system.
  • Currently receiving psychological counselling.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Португалия · 1 центр
  • William James Center for Research, Department of Education and Psychology, University of A — Aveiro

Публикации

  • World Health Organization. (2024, October 10). Mental health of adolescents. https://www.who.int/news-room/fact-sheets/detail/adolescent-mental-health
  • Woodward LJ, Fergusson DM. Life course outcomes of young people with anxiety disorders in adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Sep;40(9):1086-93. doi: 10.1097/00004583-200109000-00018. PMID 11556633
  • Wilson, C. J., Deane, F. P., Ciarrochi, J., & Rickwood, D. (2005). Measuring help-seeking intentions: Properties of the General Help-Seeking Questionnaire. Canadian Journal of Counselling, 39(1), 15-28.
  • Werner-Seidler A, Perry Y, Calear AL, Newby JM, Christensen H. School-based depression and anxiety prevention programs for young people: A systematic review and meta-analysis. Clin Psychol Rev. 2017 Feb;51:30-47. doi: 10.1016/j.cpr.2016.10.005. Epub 2016 Oct 24. PMID 27821267
  • van Doorn M, Nijhuis LA, Egeler MD, Daams JG, Popma A, van Amelsvoort T, McEnery C, Gleeson JF, Ory FG, Avis KA, Ruigt E, Jaspers MWM, Alvarez-Jimenez M, Nieman DH. Online Indicated Preventive Mental Health Interventions for Youth: A Scoping Review. Front Psychiatry. 2021 Apr 29;12:580843. doi: 10.3389/fpsyt.2021.580843. eCollection 2021. PMID 33995136
  • Tuijnman A, Kleinjan M, Olthof M, Hoogendoorn E, Granic I, Engels RC. A Game-Based School Program for Mental Health Literacy and Stigma on Depression (Moving Stories): Cluster Randomized Controlled Trial. JMIR Ment Health. 2022 Aug 17;9(8):e26615. doi: 10.2196/26615. PMID 35976200
  • Strawn JR, Lu L, Peris TS, Levine A, Walkup JT. Research Review: Pediatric anxiety disorders - what have we learnt in the last 10 years? J Child Psychol Psychiatry. 2021 Feb;62(2):114-139. doi: 10.1111/jcpp.13262. Epub 2020 Jun 5. PMID 32500537
  • Schlack R, Peerenboom N, Neuperdt L, Junker S, Beyer AK. The effects of mental health problems in childhood and adolescence in young adults: Results of the KiGGS cohort. J Health Monit. 2021 Dec 8;6(4):3-19. doi: 10.25646/8863. eCollection 2021 Dec. PMID 35146318

Идентификаторы

NCT: NCT07366580 · 2024.05050.BD · 2024.05050.BD

Первоисточники (государственные реестры)

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