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Clinical Trials/NCT07366580
NCT07366580Not yet recruitingNot Applicable

TOUCHMinds: An RCT on Help-seeking for Adolescent Anxiety

Aveiro University1 site in 1 country96 target enrollmentStarted: September 15, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
96
Locations
1
Primary Endpoint
General Help-Seeking Questionnaire (GHSQ).

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
15 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Arms & Interventions

Experimental: Clinical Group (study I and study II)

Experimental

Adolescents meeting diagnostic criteria for one or more anxiety disorders (study I n= 5; study II n = 24). Participants receive the TOUCHminds intervention. Assessments are conducted at pre-intervention (study I and II), post-intervention (9 weeks later; study I and II), and at 3-month follow-up (study II).

Intervention: TOUCHminds - Web-Based Intervention (Behavioral)

Control: Clinical Group (study II)

No Intervention

Adolescents meeting diagnostic criteria for one or more anxiety disorders (study II n = 24). Participants do not receive the intervention during the main study period but are assessed at the same time points as the intervention group: pre-intervention, post-intervention (9 weeks later), and 3-month follow-up. After completing the final assessment, they are granted access to the TOUCHminds intervention.

Experimental: Subclinical Group (study I and study II)

Experimental

Adolescents presenting subclinical anxiety symptoms (i.e., high self-reported anxiety but no mental disorder diagnosis; study I n= 5; study II n = 24). Participants receive the TOUCHminds intervention. Assessments are conducted at pre-intervention (study I and II), post-intervention (9 weeks later; study I and II), and at 3-month follow-up (study II).

Intervention: TOUCHminds - Web-Based Intervention (Behavioral)

Control: Subclinical Group (study II)

No Intervention

Adolescents presenting subclinical anxiety symptoms (i.e., high self-reported anxiety but no mental disorder diagnosis; study II n = 24). Participants do not receive the intervention during the main study period but are assessed at the same time points as the intervention group: baseline (pre-intervention), post-intervention (9 weeks later), and 3-month follow-up. After completing the final assessment, they are granted access to the TOUCHminds intervention.

Outcomes

Primary Outcomes

General Help-Seeking Questionnaire (GHSQ).

Time Frame: 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).

The GHSQ is a 12-item self-report scale that assesses adolescents' intentions to seek help for personal-emotional problems from various sources. Responses are rated on a 7-point Likert scale (1 = 'extremely unlikely' to 7 = 'extremely likely'). Its items refer to formal help (e.g., mental health professionals), semi-formal help (e.g., priests), informal help (e.g., partner), and self-help (e.g., the internet). sources. Higher scores indicate stronger intentions to seek help. The GHSQ has been adapted for use in Portugal and, despite the lack of formal psychometric studies, has been widely applied in research. For this study, the scale is further adapted to better reflect adolescents' social context. The adapted version includes formal help (e.g., psychologist), semi-formal help (e.g., teacher), informal help (e.g., friend), and self-help (e.g., online websites) sources. In addition, the original response option "I would not seek help from anyone" will be retaine.

Adolescent Help-Seeking Behavior Scale (AHSBS).

Time Frame: 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).

The AHSBS is a 17-item self-report scale developed for this study to assess how often adolescents seek help for emotional or psychological difficulties. Using the same items as the adapted GHSQ, but with new instructions, participants are asked to indicate how frequently they have turned to various sources of help in recent weeks. Responses are given on a 5-point Likert scale (1 = 'never' to 5 = 'always'). Help sources are categorized into formal, semi-formal, informal, and self-help. The total score reflects overall help-seeking frequency, with sub-scores available for each category. The AHSBS is currently under study for its psychometric properties and is expected to show good internal consistency, a structure consistent with help-seeking categories (formal, informal, semi-formal, and self-help), and construct validity in relation help-seeking intentions, stigma, and well-being.

Secondary Outcomes

  • Adolescents' Mental Health Knowledge (AMHK).(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).(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).(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).(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).(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).)

Investigators

Sponsor
Aveiro University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paula Vagos

PhD

Aveiro University

Study Sites (1)

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