Facing Fears In-session or Out-session?
Condition: Specific Phobia
Study type: Interventional

Summary: 
      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: 
      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).
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): . 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment