NCT Number: NCT07366580
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.
Trial opening soon.
Get Notified15 year–17 year
All sexes
Interventional
Not applicable
Aveiro, Portugal
Catarina Monteiro, M.Sc.
CONTACT
969232691 ext. 00351
Catarina Monteiro, M.Sc.
PRINCIPAL_INVESTIGATOR
Daniel Rijo, PhD
PRINCIPAL_INVESTIGATOR
Paula Vagos, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For all experimental and control groups, the inclusion criteria are:
Clinical Groups Specific:
Subclinical Groups Specific:
Exclusion criteria
Exclusion criteria
for all experimental and all control groups are:
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 developmental stage of adolescents and is delivered remotely to participants meeting the inclusion criteria.
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.
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.
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 AMHK is a 15-item self-report scale assessing mental health literacy in adolescents, including symptom recognition, help-seeking, and attitudes toward mental health. Items (e.g., "If someone, over a period of time, avoids or misses school parties or oral presentations because they are afraid of being judged, to what extent do you consider it likely that they are experiencing symptoms of social anxiety?") are rated on a 4-point Likert-type scale ranging from 1 ("Very unlikely" or "Very useless") to 4 ("Very likely" or "Very useful"). It was adapted from the Mental Health Literacy Scale (MHLS) and developed with input from adolescents through think-aloud sessions to ensure developmental and cultural relevance. The measure is currently undergoing validation in a Portuguese adolescent sample to assess its internal consistency, construct validity, and factorial structure.
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 PMHSS is a 24-item self-report scale that assesses peer attitudes toward adolescents with mental health problems. Of these, 16 negative items measure two components: Stigma Agreement (personal endorsement of stigmatizing beliefs) and Stigma Awareness (perceptions of societal stigma). In this study, only these 16 items were used. Items (e.g., "Most people believe that young people with emotional or behavioral problems are dangerous") are rated on a 5-point Likert scale ranging from 'strongly disagree' to 'strongly agree'. Previous psychometric information indicates good internal consistency for the negative items and acceptable values for Stigma Agreement and Stigma Awareness. The Portuguese version is currently undergoing validation in an adolescent sample to assess its internal consistency, construct validity, and factorial structure.
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 SCS-A is a 26-item self-report measure that assesses adolescents' self-compassion, defined as the ability to respond to personal difficulties with understanding and non-judgment. Items (e.g., "How I typically act toward myself in difficult times") are rated on a 5-point Likert scale (1 = 'almost never' to 5 = 'almost always'). The scale includes six subscales reflecting both compassionate (Self-Kindness, Common Humanity, Mindfulness) and uncompassionate (Self-Judgment, Isolation, Over-Identification) self-responding. Previous psychometric information on its Portuguese version indicates good internal consistency for the total scale and acceptable reliability for the subscales. Construct validity has been supported by positive associations with positive emotional memories and negative associations with symptoms of depression, anxiety, and stress.
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 URICA is a 32-item self-report scale designed to evaluate motivation for behavior change across four stages: pre-contemplation, contemplation, action, and maintenance. Items (e.g., "I have been thinking that I could change something about myself") are rated on a 5-point Likert scale (1 = 'strongly disagree' to 5 = 'strongly agree'). Each stage is scored from 8 to 32, allowing identification of the individual's predominant stage. A readiness to change score is derived by summing the scores of contemplation, action, and maintenance, and subtracting the pre-contemplation score. Previous psychometric information indicates acceptable internal consistency for the total score in late adolescents and young adults, although subscale reliability was more variable. No analyses of item quality or factorial structure were previously performed. This measure is currently being further adapted and validated for use with Portuguese adolescents.
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 MHC-SF is a 14-item self-report scale for the assessment of adolescents' flourishing based on levels of subjective well-being: emotional, social, and psychological well-being. In response to the instruction ("Please answer the following questions about how you have been feeling during the past month"), participants rate each item (e.g., "How often do you felt happy?") using a 6-point Likert scale ranging from 0 = 'Never' to 5 = 'Every day'. Previous psychometric information indicates good internal consistency values and construct validity in relation to measures of quality of life, life satisfaction, anxiety, depression and internalizing and externalizing problems.
Time frame: Completed after the interview at baseline for all groups (CGI-S), and after each intervention session for experimental groups only (CGI-S and CGI-I; Studies I-II).
The CGI is a clinician-rated measure designed to evaluate both the global severity of illness and changes in clinical status over time. It consists of three subscales: Severity of Illness (CGI-S), Global Improvement (CGI-I), and Efficacy Index. In the present study, only the CGI-S and CGI-I will be used. The CGI-S, which evaluates the severity of psychopathology, is rated on a seven-point scale, ranging from 1 = 'normal' to 7 = 'among the most extremely ill'. The CGI-I, which assesses the perceived change since the initiation of the intervention, is also rated on a seven-point scale, ranging from 1 = 'very much improved' to 7 = 'very much worse', and reflects clinical change relative to the participant's initial evaluation. For the current study, items were translated and adapted to European Portuguese by experts in clinical assessment and intervention, ensuring both linguistic and cultural adequacy.
Contact information is provided by the study sponsor or research team.
Aveiro University
Other
TOUCHMinds: An RCT on Help-seeking for Adolescent Anxiety
Acronym: TOUCHminds
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06475040
Anxiety Disorders, Anxiety Symptoms
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT03707158
Anxiety, Anxiety Disorders
Miami, Florida, United States
View Trial DetailsNCT06315218
Anxiety Disorders, Anxiety Symptoms
View Trial DetailsNCT07427524
Anxiety Disorders, Anxiety Symptoms
Paris, France
View Trial Details