School-based Interventions for Test Anxiety in Adolescents

Anxiety Clinical Trial

Official title:

Reducing Clinical Anxiety in Adolescents Through Selective Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03610542
• Other study ID #: EHC0341
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2020
• Source: Liverpool John Moores University
• Contact: David W Putwain, PhD
• Phone: (+44) 0151 231 5270
• Email: d.w.putwain[@]ljmu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the clinical and cost effectiveness of test anxiety as a form of selective prevention for clinical anxiety. Participants will be randomly allocated to cognitive behavioural therapy without booster sessions, cognitive behavioural therapy with two booster sessions, or a no intervention control.

Description:

Test anxiety affects a substantial proportion of adolescents, who show an increased risk of suicide, and of developing clinical anxiety and poor mental health. Externally resourced school-based cognitive behavioural therapy (CBT) interventions have been shown to be effective in treating test anxiety. Intervening in test anxiety, a sub-clinical anxiety, may prevent anxieties from developing into a clinical disorder. The primary outcomes are test anxiety, clinical anxiety, and wellbeing, measured at baseline, post-intervention, and 6 and 12-month follow-up. In addition, to identify treatment mechanisms additional measures are taken of uncertain control, metacognition, and emotional regulation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

Inclusion Criteria:

• Participants are aged 14-16 years of age

• In the upper 66th percentile of test anxiety scores

Exclusion Criteria:

• Participants are receiving other treatment for anxiety

• Participants have a diagnosis of clinical anxiety depression or Attention Deficit Hyperactivity Disorder

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Triggers for anxiety
Students learn about different triggers for anxiety, what the signs and indicators of anxiety are, and identify their own triggers for anxiety
• Identifying and challenging negative thoughts
Students learn about the types of unrealistic thoughts that underpin anxiety and how anxiety can be reduced with more realistic thoughts. Students identify their own unrealistic thoughts that contribute to anxiety and what more realistic thoughts can be used.
• Relaxation
Students are taught to relax through (1) breathing exercises, (2) progressive muscle relaxation, and (3) imagery. Student practice these techniques.
• Goal Setting
Students learn how to set goals, monitor goal progress, and check when goals have been achieved. Students then identify their own goals.
• Overcoming avoidance
Students identify ways that they avoid anxiety-provoking situations (e.g., procrastinating exam study). Students develop plans for exposure to anxiety-provoking situations and learn study strategies to build confidence.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Liverpool John Moores University	Leeds University, Manchester University, The Welcome Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test Anxiety Inventory	The Test Anxiety Inventory is a 20 item measure measured on a 4-point scale (1 = Almost Never, 4 = Almost Always). Three scores are provided: Total (20 items), worry subscale (8 items) and emotionality (8 items). The total score range is 20-80 and the worry and emotionality subscale scores are 8-32. A higher score represents higher anxiety. This will administered 4 times over a 12 month period to assess change: Baseline, 6 weeks (immediate-post intervention), 6-month follow-up and 12 month follow-up.	Change assessed over a 12 month period
Secondary	The Metacognition Questionnaire	The Metacognition Questionnaire is a 30-item questionnaire that consists of six subscales: Cognitive confidence, positive beliefs, cognitive self-consciousness, uncontrollability and danger, and need to control thoughts. Each subscale comprises of 5 items and uses a 4-point scale (1 = do not agree, 4 = agree very much) and the range of scores for each subscale is 5-20. A higher score represents negative beliefs about worry. These subscales will administered 4 times over a 12 month period to assess change: Baseline, 6 weeks (immediate-post intervention), 6-month follow-up and 12 month follow-up.	Change assessed over a 12 month period
Secondary	Cognitive Emotion Regulation Questionnaire (short version)	The Cognitive Emotion Regulation Questionnaire has 18 items and consists of nine subscales: Self-blame, other-blame, rumination, catastrophizing, positive refocusing, planning, positive reappraisal, putting into perspective and acceptance. Each subscale comprises of 2 items and uses a 5-point scale (1 = almost never, 5 = almost always) and the range of scores for each subscale is 2-10. A higher score represents greater use of cognitive coping strategies. These subscales will administered 4 times over a 12 month period to assess change: Baseline, 6 weeks (immediate-post intervention), 6-month follow-up and 12 month follow-up.	Change assessed over a 12 month period
Secondary	Motivation and Engagement Scale (uncertain control subscale)	4 items measure measured on a 7-point scale (1 = strongly disagree, 7 = strongly agree) resulting in a score from 7-28. A higher score represents greater uncertain control. This subscale will administered 4 times over a 12 month period to assess change: Baseline, 6 weeks (immediate-post intervention), 6-month follow-up and 12 month follow-up.	Change assessed over a 12 month period
Secondary	Revised Children's Anxiety and Depression Scale (panic, generalized anxiety, and social anxiety subscales)	The generalised anxiety subscale (6 items), panic subscale (9 items), and social anxiety subscale (9 items) of the Revised Children's Anxiety and Depression Scale, are all measured on a 4-point scale (0 = Never, 3 = Always). The range of scores for the generalised anxiety subscale is 0-18, the panic subscale is 0-27, and the social anxiety subscale is 0-27. A higher score represents higher anxiety. These subscales will administered 4 times over a 12 month period to assess change: Baseline, 6 weeks (immediate-post intervention), 6-month follow-up and 12 month follow-up.	Change assessed over a 12 month period
Secondary	School-related Wellbeing Scale	6 items measured on a 5-point scale (1 = Strongly Disagree, 5 = Strongly Agree) resulting in a score from 6-30. A higher score represents higher school-related wellbeing. These subscales will administered 4 times over a 12 month period to assess change: Baseline, 6 weeks (immediate-post intervention), 6-month follow-up and 12 month follow-up.	Change assessed over a 12 month period