School-based Interventions for Test Anxiety in Adolescents

September 2, 2020 updated by: Liverpool John Moores University

Reducing Clinical Anxiety in Adolescents Through Selective Intervention

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behaviour Therapy
Cognitive behaviour therapy conducted in groups of 6-8 persons.One forty-five minute session per week for 6 weeks: Triggers for anxiety, identifying and challenging negative thoughts, relaxation, overcoming avoidance, and goal setting.
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
Other Names:
  • STEPS
Behavioral: 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.
Other Names:
  • STEPS
Behavioral: Relaxation
Students are taught to relax through (1) breathing exercises, (2) progressive muscle relaxation, and (3) imagery. Student practice these techniques.
Other Names:
  • STEPS
Behavioral: Goal Setting
Students learn how to set goals, monitor goal progress, and check when goals have been achieved. Students then identify their own goals.
Other Names:
  • STEPS
Behavioral: 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.
Other Names:
  • STEPS
Experimental: Cognitive Behaviour Therapy with 2 Booster Sessions
Cognitive behaviour therapy conducted in groups of 6-8 persons.One forty-five minute session per week for 6 weeks: Triggers for anxiety, identifying and challenging negative thoughts, relaxation, overcoming avoidance, and goal setting. 2 booster sessions (forty-five minutes each) will be provided at three and nine months. Each session will recap the content of the initial 6 sessions.
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
Other Names:
  • STEPS
Behavioral: 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.
Other Names:
  • STEPS
Behavioral: Relaxation
Students are taught to relax through (1) breathing exercises, (2) progressive muscle relaxation, and (3) imagery. Student practice these techniques.
Other Names:
  • STEPS
Behavioral: Goal Setting
Students learn how to set goals, monitor goal progress, and check when goals have been achieved. Students then identify their own goals.
Other Names:
  • STEPS
Behavioral: 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.
Other Names:
  • STEPS
No Intervention: Control
This is a no intervention control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test Anxiety Inventory
Time Frame: Change assessed over a 12 month period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Metacognition Questionnaire
Time Frame: Change assessed over a 12 month period
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
Cognitive Emotion Regulation Questionnaire (short version)
Time Frame: Change assessed over a 12 month period
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
Motivation and Engagement Scale (uncertain control subscale)
Time Frame: Change assessed over a 12 month period
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
Revised Children's Anxiety and Depression Scale (panic, generalized anxiety, and social anxiety subscales)
Time Frame: Change assessed over a 12 month period
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
School-related Wellbeing Scale
Time Frame: Change assessed over a 12 month period
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool John Moores University

Collaborators

The Welcome Trust
Manchester University
Leeds University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHC0341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

A curated dataset will be uploaded to the Mendeley Open Data repository and assigned a doi that can be linked to all published articles via Science Direct

IPD Sharing Time Frame

Data will be uploaded in December 2022 and remain available permanently

IPD Sharing Access Criteria

Registration with Mendeley Open Data or Science Direct

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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