search
Back to results

School-based Interventions for Test Anxiety in Adolescents

Primary Purpose

Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Triggers for anxiety
Identifying and challenging negative thoughts
Relaxation
Goal Setting
Overcoming avoidance
Sponsored by
Liverpool John Moores University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Test Anxiety, Wellbeing

Eligibility Criteria

14 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Cognitive Behaviour Therapy

    Cognitive Behaviour Therapy with 2 Booster Sessions

    Control

    Arm Description

    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.

    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.

    This is a no intervention control arm

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    July 16, 2018
    Last Updated
    September 2, 2020
    Sponsor
    Liverpool John Moores University
    Collaborators
    The Welcome Trust, Manchester University, Leeds University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03610542
    Brief Title
    School-based Interventions for Test Anxiety in Adolescents
    Official Title
    Reducing Clinical Anxiety in Adolescents Through Selective Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Liverpool John Moores University
    Collaborators
    The Welcome Trust, Manchester University, Leeds University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety
    Keywords
    Test Anxiety, Wellbeing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly allocated to one of three conditions: Cognitive behavioural therapy with no booster sessions, Cognitive behavioural therapy with 2 booster sessions or a no intervention control arm.
    Masking
    Participant
    Masking Description
    Sequentially numbered opaque sealed envelopes will be used to conceal allocation. Envelopes will be prepared by a member of the research team and opened by participants.
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive Behaviour Therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Cognitive Behaviour Therapy with 2 Booster Sessions
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    This is a no intervention control arm
    Intervention Type
    Behavioral
    Intervention Name(s)
    Triggers for anxiety
    Other Intervention Name(s)
    STEPS
    Intervention Description
    Students learn about different triggers for anxiety, what the signs and indicators of anxiety are, and identify their own triggers for anxiety
    Intervention Type
    Behavioral
    Intervention Name(s)
    Identifying and challenging negative thoughts
    Other Intervention Name(s)
    STEPS
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Relaxation
    Other Intervention Name(s)
    STEPS
    Intervention Description
    Students are taught to relax through (1) breathing exercises, (2) progressive muscle relaxation, and (3) imagery. Student practice these techniques.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Goal Setting
    Other Intervention Name(s)
    STEPS
    Intervention Description
    Students learn how to set goals, monitor goal progress, and check when goals have been achieved. Students then identify their own goals.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Overcoming avoidance
    Other Intervention Name(s)
    STEPS
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Test Anxiety Inventory
    Description
    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.
    Time Frame
    Change assessed over a 12 month period
    Secondary Outcome Measure Information:
    Title
    The Metacognition Questionnaire
    Description
    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.
    Time Frame
    Change assessed over a 12 month period
    Title
    Cognitive Emotion Regulation Questionnaire (short version)
    Description
    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.
    Time Frame
    Change assessed over a 12 month period
    Title
    Motivation and Engagement Scale (uncertain control subscale)
    Description
    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.
    Time Frame
    Change assessed over a 12 month period
    Title
    Revised Children's Anxiety and Depression Scale (panic, generalized anxiety, and social anxiety subscales)
    Description
    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.
    Time Frame
    Change assessed over a 12 month period
    Title
    School-related Wellbeing Scale
    Description
    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.
    Time Frame
    Change assessed over a 12 month period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David W Putwain, PhD
    Phone
    (+44) 0151 231 5270
    Ext
    5270
    Email
    d.w.putwain@ljmu.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Seddon, BSc
    Phone
    (+44) 0151 231 4534
    Ext
    4534
    Email
    d.seddon@ljmu.ac.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

    Learn more about this trial

    School-based Interventions for Test Anxiety in Adolescents

    We'll reach out to this number within 24 hrs