Anxiety Disorders Clinical Trial
Official title:
Augmented Treatment of Specific Phobias in Children
This study will compare the effectiveness of two types of cognitive behavioral therapy, one-session exposure treatment and family-enhanced one-session exposure treatment, in treating children with specific phobias.
A specific phobia is a fear of a particular object or situation. For many children, phobias
result in considerable academic difficulties, social and personal distress, and interference
in day-to-day activities. Physical symptoms typically accompany the intense anxiety caused
by a specific phobia and may include blushing, profuse sweating, trembling, nausea, and
difficulty talking. Phobias can persist a lifetime and may lead to other adult anxiety,
mood, and substance use disorders. One-session exposure treatment (OST), a form of cognitive
behavior therapy, has been considered a rapid and effective treatment for adults with a
variety of specific phobias. Upward of 75 to 80% of adults treated with OST were considered
diagnoses free following treatment. OST has proven useful in treating some children with
specific phobias but not all. It is possible that parental factors may affect whether a
child continues to experience a phobia and how well a child responds to treatment. For
example, parents who are overly protective or have a phobia themselves may prevent their
child from overcoming a specific phobia. Family-enhanced OST (augmented OST) involves the
parents of affected children and provides the parents with strategies to assist their
children in overcoming phobias. This study will compare the effectiveness of OST and
augmented OST in treating children with specific phobias. This study will also evaluate how
parental factors influence the expression and maintenance of phobias in children.
Participants in this study will be randomly assigned to receive OST or augmented OST.
Participants receiving OST will attend one extended treatment session, lasting up to 3 hours
in duration. During this session, the child will be taught a number of cognitive and
behavioral skills to deal effectively with the feared situation or object. The child will
also be exposed to the feared situation or object in a highly structured, safe, and
controlled manner. This treatment will only be delivered to the child and will not involve a
parent or guardian. Participants receiving augmented OST will attend the same type of
extended treatment session, but, in addition, their parent or guardian will attend a 3-hour
session. During this session, parents will first be educated on specific phobias, including
why phobias occur and how they are maintained over time. Next, parents will observe their
child being treated from behind a one-way mirror for about 1 hour. During this time, a
therapist will explain what the child's therapist is doing and discuss ways for parents to
implement the treatment at home. Parents will then be asked to join their child and the
therapist for the last hour of the child's session to assist the therapist with treatment.
Outcomes will be assessed for all participants immediately after treatment and at 1-, 6-,
and 12-month follow-up evaluations during which the presence of specific phobias will be
measured. Parents will also be asked to provide information about their child's school
grades and school attendance for the year prior to participating in the study and up to 1
year after the child completes the treatment. The child's teacher may be asked to complete a
questionnaire regarding the child's behavior in school. All of the information collected
will help to determine how much progress each child has made as a result of treatment.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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