Clinical trial NCT05027880: Web-based Single-session Growth Mindset Intervention for Adolescent Anxiety
Official title: Examination of Web-based Single-session Growth Mindset Interventions for Reducing Adolescent Anxiety: A Four-arm Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Generalized
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 731
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anxiety disorders are the most common mental disorders worldwide. In Hong Kong, 7% of adolescents are diagnosed with anxiety disorders, and one in every four secondary school students reports clinical-level anxiety symptoms. However, 65% of them do not access services. Long waitlists in public services, the high cost of private services, or the fear of being stigmatized can hinder service access. The high prevalence of anxiety and low intervention uptake indicate a pressing need to develop timely, scalable, and potent interventions suitable for adolescents. Single-session interventions (SSIs) have the potential to be scalable interventions for diagnosable or subclinical psychopathology in adolescents. Providing precise and context-adapted intervention is the key to achieving intervention efficacy. This study aims to compare the effectiveness of four SSIs: Single-session Intervention of Growth Mindset for Anxiety (SIGMA), SIGMA with booster messages, SSI of Growth mindset of Personality (SSI-GP), and active control using support therapy (ST), in reducing adolescent anxiety. Adolescents (N=731, aged 12-20) from secondary schools have been randomized to one of the four intervention conditions: the SIGMA, SIGMA-BOOSTER, SSI-GP, or active control. The implementation of each intervention is approximately 45 minutes in length. Adolescent participants reported anxiety symptoms, depression symptoms, and suicidal/self-hurting thoughts (primary outcomes); perceived control, hopelessness, attitude toward help-seeking and psychological well-being (secondary outcomes) at pre-intervention, the 2-week and 8-week follow-up. A pilot test has confirmed the feasibility and acceptability of SIGMA among adolescents. We hypothesized that SIGMA (including SIGMA and SIGMA-BOOSTER) and SSI-GP will result in a larger reduction in anxiety symptoms than the control intervention. We also predict SIGMA (including SIGMA and SIGMA-BOOSTER) will be more effective than SSI-GP. We will use the intention-to-treat principle and generalised estimating equation models for data analysis. This study was conducted from December 2022 to June 2023, with results expected to be available by March 2024. This protocol introduces the implementation content and strategies of growth mindset SSIs among school students. The study will provide evidence on the efficacy of different growth mindset SSIs for adolescent anxiety. It will also establish implementation strategies for self-administrative SSIs among school students, which can serve as a pioneer implementation of a scalable and self-accessible brief intervention to improve the well-being of young people.


Eligibility criteria: Inclusion Criteria:

1. secondary school students in grades 7-11;
2. Chinese youth who can read and write Chinese;
3. enough visual and auditory abilities to complete the intervention and assessment;
4. ability to give assent to participate in the study.

Exclusion Criteria:

1. no parental consent;
2. inability to stay focused to complete the intervention which is approximately 45 minutes;
3. intellectual disability or severe illness or pain that would lead to significant bias in students' health and mental health situation.

Primary outcomes:
measure: Anxiety Symptoms
timeFrame: baseline
measure: Anxiety Symptoms
timeFrame: 2-week post-intervention
measure: Anxiety Symptoms
timeFrame: 8-week post-intervention
measure: Depression, and suicidal/self-hurting thoughts
timeFrame: baseline
measure: Depression, and suicidal/self-hurting thoughts
timeFrame: 2-week post-intervention
measure: Depression, and suicidal/self-hurting thoughts
timeFrame: 8-week post-intervention
Secondary outcomes:
measure: Perceived control
timeFrame: baseline
measure: Perceived control
timeFrame: 2-week post-intervention
measure: Perceived control
timeFrame: 8-week post-intervention
measure: Hopelessness
timeFrame: baseline
measure: Hopelessness
timeFrame: 2-week post-intervention
measure: Hopelessness
timeFrame: 8-week post-intervention
measure: Attitude towards seeking help
timeFrame: baseline
measure: Attitude towards seeking help
timeFrame: 2-week post-intervention
measure: Attitude towards seeking help
timeFrame: 8-week post-intervention
measure: Psychological wellbeing
timeFrame: baseline
measure: Psychological wellbeing
timeFrame: 2-week post-intervention
measure: Psychological wellbeing
timeFrame: 8-week post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: