NCT07366580

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
8 months until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

January 9, 2026

Last Update Submit

January 16, 2026

Conditions

Keywords

AnxietyAdolescentsHelp-seekingWeb-based intervention

Outcome Measures

Primary Outcomes (2)

  • General Help-Seeking Questionnaire (GHSQ).

    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.

    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).

    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.

    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).

Secondary Outcomes (5)

  • 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).

Other Outcomes (1)

  • Clinical Global Impression Scale (CGI).

    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).

Study Arms (4)

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).

Behavioral: TOUCHminds - Web-Based Intervention

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).

Behavioral: TOUCHminds - Web-Based Intervention

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.

Interventions

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.

Experimental: Clinical Group (study I and study II)Experimental: Subclinical Group (study I and study II)

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William James Center for Research, Department of Education and Psychology, University of Aveiro.

Aveiro, Portugal

Location

Related Publications (50)

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MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Catarina Monteiro, M.Sc.

    William James Center for Research, Department of Education and Psychology, University of Aveiro.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catarina Monteiro, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This investigation comprises two sequential studies. Study I (feasibility) is a single-arm, pre-post study design with two intervention groups (clinical, n=5; subclinical, n=5), both receiving the TOUCHminds. Study I will assess recruitment procedures, dropout rates, usage patterns, therapist fidelity, acceptability, usability, satisfaction, and preliminary effects. Study II (RCT) is a randomized, controlled, parallel-group trial evaluating the effectiveness of the TOUCHminds in adolescents with clinical and subclinical anxiety symptoms. Participants will be randomly assigned to one of four conditions: Clinical Intervention (n = 24), Clinical Control (n = 24), Subclinical Intervention (n = 24), or Subclinical Control (n = 24).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 26, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations