Facing Fears In-session or Out-session?

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Specific Phobia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapist-guided in-session<br>The participants will engage in 2 x 45 minutes of exposure exercises conducted together with the therapist in the mental health care centre. In addition, they will conduct 2 x 45 minutes of exposure exercises by themselves out of session as a homework assignment. | Behavioral: Cognitive Behavioral Therapy<br>* . 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.<br>|
| Experimental: Self-guided out-session<br>The participants will prepare and discuss the exposure exercises together with the therapist in the mental health care centre, and conduct 2 x 2 x 45 minutes of exposure exercises by themselves out of session as a homework assignment. | Behavioral: Cognitive Behavioral Therapy<br>* . 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.<br>|
| Experimental: Parent-guided out-session<br>The participants and one of their parents will prepare and discuss the exposure exercises together with the therapist in the mental health care centre, and conduct 2 x 2 x 45 minutes of exposure exercises together with their parent out of session as a homework assignment. | Behavioral: Cognitive Behavioral Therapy<br>* . 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in specific phobia severity (Interference, number of symptoms and general impression of the psychologist) | 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of anxiety (Subjective level of fear, Fearful cognitions, Bodily tension, Avoidance and Coping) | 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) | 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) | 
| Change in approach behaviour towards phobic stimulus (Time and distance) | 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. | At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6) | 
| Change in self-efficacy (Academic, Social and Emotional) | 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). | At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6) |