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Completed

NCT Number: NCT03688360

Facing Fears In-session or Out-session?

Anxiety problems are a major concern of youth mental health given that the prevalence of anxiety disorders in Dutch children aged up to 12 is approximately 4 to 8 percent. In this group, specific phobias are among the most common. Cognitive Behavioral Therapy (CBT) with exposure as its key ingredient, takes a prominent place in national guidelines for the treatment of anxiety disorders. These guidelines are based on empirical support that exposure is effective in the treatment of specific phobia. Yet, despite the empirical evidence of its efficacy, a gap between theory and practice remains, with exposure-based CBT being underused in clinical practice. For example, a recent Dutch survey found that exposure was mostly practiced outside the formal therapy sessions as homework assignment. It is questionable whether this is effective, given that it might be hard for children to do these assignments independently (e.g., without the help of a therapist or their parents). This study therefore proposes to evaluate the effectiveness of different degrees of therapist and parent involvement during exposure, comparing therapist supported exposure with self-supported exposure with and without the use of parents as co-therapists.

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Key information

Conditions

Specific Phobia Phobia, Specific

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Accare Universitair Centrum voor Kinder en Jeugdpsychiatrie

Groningen, 9713 GZ, Netherlands

About this study

Objective: The primary goal of this study is to evaluate whether therapist supported in-session exposure exercises are more effective than individual out-session exposure exercises, or parent supported out-session exposure exercises. The secondary goal is to find child, parent and therapist factors that possibly relate to the effectiveness of the exposure exercises.

Study design: Randomized Controlled Trial (RCT) with three parallel groups (intervention versus intervention versus intervention).

Study population: Children aged 8 to 12 years with a specific phobia of the animal/situational subtype

Intervention (if applicable): The intervention will be designed as a CBT, a therapy which has proven to be effective in treating specific phobia. The intervention consists of three individual sessions, each up to 60 minutes long. Each condition starts with a psycho-education session on specific phobias and exposure. In the following two sessions, that differ per condition, either two therapist-guided in-session exposure exercises or two self-guided out-session exposure sessions are offered. In the out-session exposure sessions the child conducts the exposure exercises either with or without the help of a parent. The intervention will be provided by an experienced mental health professional.

Main study parameters/endpoints (see outcome measures paragraph): The main study parameter is specific phobia severity. Secondary study parameters are subjective level of fear, fearful cognitions, bodily tension, avoidance, coping (possible mediator variables), approach behavior and self-efficacy. Tertiary study parameters are healthcare costs and quality of life (cost-effectiveness), note: cost-effectiveness is assessed for another study. Other study parameters are specific phobiadiagnosis, general comorbidity, comorbid anxiety and depression, parental fear, parental modelling behaviors, and demographic variables (possible moderator variables); and credibility and expectancy of the treatment, treatment compliance, treatment satisfaction, and therapeutic alliance (treatment characteristics).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 8-12 years old and in primary school
  • Sufficient knowledge of the Dutch language
  • Meeting the criteria of a specific phobia of the situational or animal subtype

Exclusion criteria

  • Absence of permission of legal guardian(s)
  • Currently in treatment or receiving medication for anxiety
  • Received CBT for anxiety in the past 12 months
  • Specific phobia that do not fall under the situational or animal subtype, for example:
  • Aerophobia: fear of flying
  • Emetophobia: fear of vomiting
  • Hemophobia: fear of blood
  • Hosophobia: fear of infection
  • Astraphobia: fear of lightning
  • Different and more urgent request for help
  • (Risk of) suicidality, psychosis or domestic violence

Treatment and study plan

Cognitive behavioral therapy

Behavioral

. Each intervention will contain a 60-minute psycho-education session (PE) and two 60-minute exposure sessions (EX), conducted by a mental health professional together with a master student in psychology, who are both weekly supervised by a CBT certified psychologist. In the first (PE) session, participants learn about anxiety, specific phobias and exposure. During this session they will create a fear hierarchy, formulate their cognition about the feared object or situation and determine what they want to achieve during treatment (e.g. goal situation). The next two sessions consist of exposure exercises.

Primary outcomes

  1. Change in specific phobia severity (Interference, number of symptoms and general impression of the psychologist)

    Time frame: At intake (T0), four weeks later at pre-intervention assessment (T1), another four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

    Specific phobia severity in children will be measured with a clinical semi-structured interview using the Anxiety Disorder Interview Schedule for Children and Parents (ADIS-IV-C/P). The study will only include the section of specific phobia. Severity of the specific phobia will be rated on a 0-8 interval scale by an independent psychologist on the ADIS-IV (see above). This rating is based on the level of interference, number of symptoms and general impression of the psychologist. A rating 0, 1, 2 or 3 is labelled as no specific phobia, a rating of 4 or 5 is labelled as a mild specific phobia, whereas a rating of 6, 7 or 8 means the specific phobia is labelled as severe. This rating is used to randomize the participants to one of the conditions. The ADIS-IV has good test-retest reliability and concurrent validity.

Secondary outcomes

  1. Change in level of anxiety (Subjective level of fear, Fearful cognitions, Bodily tension, Avoidance and Coping)

    Time frame: During the first intervention week (T2), the second week (T3), and the third week (T4), and one week later at post-intervention assessment (T5), and four weeks later at follow-up assessment (T6)

    Level of anxiety compromised of Subjective level of fear, Fearful cognitions, Bodily tension, Avoidance and Coping will be measured by Visual Analogue Scales (VAS) ranging from 0-100 (ratio scale) on which the child rates the following aspects of the goal situation as set in the PE session:

    • Subjective level of fear: 'Not frightened at all' (0) - 'Completely frightened' (100)
    • Fearful cognitions: 'I do not believe this at all' (0) - 'I completely believe this' (100), in which the credibility of the cognition about the feared object or situation as set in the PE session is rated.
    • Bodily tension: 'My body feels not tense at all' (0) - 'My body feels completely tense' (100)
    • Avoidance: 'I would never avoid this situation/object if I could' (0) - 'I would always avoid this situation/object if I could' (100)
    • Coping: 'I cannot cope with this situation/object at all when I encounter it' (0) - 'I can completely cope with this situation/object when I encounter it' (100)

  2. Change in approach behaviour towards phobic stimulus (Time and distance)

    Time frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

    Approach behaviour will be measured by three situational Behavioural Approach Tests (BAT) for feared and avoided objects or situations. The test consists of a number of increasingly difficult steps in which children are asked to approach a phobic object or situation, but are told they can stop the test at any time they wish to do so. During the BAT, individuals are asked to provide "subjective unit of disturbance scale" (SUDS 0-100 ratio scale) ratings immediately after encountering the phobic animal or situation.

  3. Change in self-efficacy (Academic, Social and Emotional)

    Time frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

    Self-efficacy will be measured by the Self Efficacy Questionnaire for Children (SEQ-C; Muris, 2001). This questionnaire contains 24 questions regarding academic, social and emotional self-efficacy. Items are rated on a 5-point interval scale from 'not at all' (1) to 'very well' (5). The SEQ-C is proven to be a valid instrument with sufficient reliability (Muris, 2001).

Other outcomes

  1. Cost-effectiveness (Healthcare costs and In quality adjusted life years)

    Time frame: At pre-intervention assessment (T1) and eight weeks later at follow-up assessment (T6)

    In addition, cost-effectiveness of the intervention will be assessed by measuring costs and quality of life (effectiveness). Measuring cost-effectiveness is not the primary goal of this research but since this study is part of a larger national project in which cost-effectiveness will also be taken into account, we consider it relevant to state here.

    • Healthcare costs will be measured by registration of costs in a cost diary based on the Trimbos Institute and Institute of Medical Technology Assessment Questionnaire on Costs Associated with Psychiatric Illness (TiC-P) and PRODISQ.
    • The EuroQol Questionaire (EQ-5D-Y youth version) will be used to establish quality of life as expressed in quality adjusted life years (QALYs).

    Healthcare costs and in quality adjusted life years will be combined to report cost-effectiveness.

  2. Change in specific phobia diagnosis (Interference, number of symptoms and general impression of the psychologist)

    Time frame: At intake (T0), four weeks later at pre-intervention assessment (T1), another four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

    Specific phobia diagnosis will be assessed with the ADIS IV (see above). All items offer three possible answers: 'yes', 'no' or 'other' on a nominal scale (which is chosen when the adolescent answers 'I don't know' or 'sometimes'). If the adolescent meets all four criteria for specific phobia as set in the ADIS-IV, he or she can participate in the study.

  3. Change in comorbid anxiety and depression symptoms

    Time frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

    Given the high comorbidity of anxiety and depression in children, comorbid anxiety and depression will be assessed with the Revised Child Anxiety and Depression Scale for Children and Parents (RCADS-C/P) consisting of 47 items and the Phobia section of the Spence Children's Anxiety Scale for Children and Parents (SCAS-C/P) consisting of 9 items. All items are rated on a 4-point interval scale from 'never' to 'always'. Both the RCADS and the SCAS have good psychometric properties and are combined into the RCADSCAS for this study.

  4. Change in parental fear (Phobia, Avoidance and Associated anxiety)

    Time frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

    Parental fear will be measured by the Fear Questionnaire (FQ). This questionnaire contains 24 questions regarding phobia, avoidance, and associated anxiety. The specific phobia of the child will be added idiosyncratically for each family. Items are rated on an 8-point interval scale from 'no fear' to 'in panic'. Reliability and construct validity have proven to be sufficient.

  5. Change in parental modelling behaviours (Modelling and Reassurance)

    Time frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

    Parental modelling behaviours will be measured by the modelling/reassurance scale of the Child Development Questionnaire (CDQ). This scale contains 18 items all rated on a 5-point interval scale from 'never' to 'always'.

  6. Change in treatment credibility and expectancy of the treatment

    Time frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

    • Credibility and expectancy of the treatment are measured by the Credibility and Expectancy Questionnaire (CEQ-C/P). This questionnaire contains 6 items all rated on a 9-point interval scale. The psychometric properties of the scale have been qualified as good.

  7. Change in treatment satisfaction

    Time frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

    • Treatment satisfaction will be measured with the Service Satisfaction Scale (SSS). Four items are rated on a 4-point interval scale ranging from 'no, definitely not' to 'yes, definitely'. The psychometric properties of the scale have been qualified as good.

  8. Change in compliance to the treatment

    Time frame: During the second intervention week (T3), and the third intervention week (T4), and one week later at post-intervention assessment (T5), and four weeks later at follow-up assessment (T6)]

    Treatment compliance will be measured using a weekly checklist in which the child and parent can state how much time they spent on the out-session exposure homework assignment, rated in minutes.

  9. Therapeutic alliance in the treatment

    Time frame: One week after the last intervention week, at post-intervention assessment (T5)

    Therapeutic alliance is measured by the Therapeutic Alliance Scale for Children and Parents (TAS-C/P). Both parts consist of 12 items rated on a 4-point interval scale. The psychometric properties of the scale have been qualified as good.

Sponsors and collaborators

Lead sponsor

University of Groningen

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Optimizing Exposure in the Treatment of Anxiety in Youth: Facing Fears In-session or Out-session?

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2018
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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